Author: Editor

Harold A. Burstein, M.D, discusses guideline updates on integration results from TAILORx. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline UpdateIntegration of Results from TAILORx Guideline Question For women with early-stage invasive breast cancer, which other biomarkers have demonstrated clinical utility to guide decisions on the need for adjuvant systemic therapy? Target Population Women with early-stage invasive breast cancer being considered for adjuvant systemic therapy. Target Audience Medical, surgical, and radiation oncologists; oncology nurses and physician assistants; pathologists; general practitioners; and patients. Methods An Expert Panel was…

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Thomas Yau MD, MBBS Of University of Hong Kong Discusses Nivolumab + Ipilimumab Combo Therapy In Patients with aHCC Results From CheckMate 040: ORR of 14& mOS of 16 Months, First Report of Efficacy & Safety of The NIVO + IPI combo in SOR-Treated patients With aHCC. BACKROUND: NIVO monotherapy (mono) is approved for sorafenib (SOR)-treated pts with HCC based on data from CheckMate 040 (NCT01658878), which reported an objective response rate (ORR) of 14% and median overall survival (mOS) of 16 months (mo). This is the first report of efficacy and safety of the NIVO + IPI combination in…

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Larissa Nekhlyudov MD MPH Of Brigham & Womens Hospital/Dana-Farber Cancer Institute, Harvard Medical School Discusses Bringing Primary Physician Back Into The Care Of Patients With Cancer: Not All Primary Care Physicians Feel Comfortable Or Would Like To Engage With Their Patients While They Are Getting Cancer Care. BACKROUND: CancerLinQ Discovery (CLQD) is a real-world dataset (RWD) derived from electronic health records across the US. This analysis builds on the prior observation of cautioned use of bevacizumab (Bev) among older adults using Medicare claims data. The goals of this study are to estimate the prevalence and incidence of hypertension (HT) and…

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Larissa Nekhlyudov MD MPH Of Brigham & Womens Hospital/Dana-Farber Cancer Institute, Harvard Medical School Discusses Need To Optimize Communication & Care Coordination: Sexual Health Is Important & Doctors Need To Ask Questions About It, Electronic Health Records Have Potential To Improve Communication. BACKROUND: CancerLinQ Discovery (CLQD) is a real-world dataset (RWD) derived from electronic health records across the US. This analysis builds on the prior observation of cautioned use of bevacizumab (Bev) among older adults using Medicare claims data. The goals of this study are to estimate the prevalence and incidence of hypertension (HT) and blood pressure (BP) patterns among…

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Scott Tagawa MD @drscottagawa Of Weill Cornell Medicine and NewYork-Presbyterian Discusses Some That Image Well Do Not Respond: BRCA2 Is Associated With A Better Outcome While p53 Alterations May Have A Worse Prognosis. BACKROUND: Testosterone suppression (TS) is the backbone of treatment for mHSPC. OS is improved by the addition of early docetaxel (DOC) or abiraterone to TS. ENZAMET assessed the effects of enzalutamide (ENZA), a potent androgen receptor (AR) inhibitor, versus a nonsteroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide) in addition to SOC (TS with or without DOC) in mHSPC. METHODS: Men with mHSPC were randomly assigned 1:1 to…

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Scott Tagawa MD @drscottagawa Of Weill Cornell Medicine and NewYork-Presbyterian Discusses If They Are Imaging Negative, How Are They Responding: No Imaging Modality Is Perfect, 80% Use Plain Imaging Which Is Not As Sensitive As What Were Doing Now. BACKROUND: Patients (pts) with advanced urothelial cancer (UC) who progress after checkpoint inhibitor (CPI) therapy (following failure of or ineligibility for platinum-based chemotherapy) have limited options. Trop-2 is an epithelial cell surface antigen overexpressed in UC (Avellini. Oncotarget 2017). Sacituzumab govitecan (SG) is an antibody-drug conjugate that targets Trop-2 and delivers the active metabolite SN38 of the topoisomerase I inhibitor irinotecan…

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Scott Tagawa MD @drscottagawa Of Weill Cornell Medicine and NewYork-Presbyterian Discusses TROPHY-u-01 Trial: A Phase II Open-Label Study Of Sacituzumab Govitecan (IMMU-132) In Patients With Advanced Urothelial Cancer.BACKROUND: Patients (pts) with advanced urothelial cancer (UC) who progress after checkpoint inhibitor (CPI) therapy (following failure of or ineligibility for platinum-based chemotherapy) have limited options. Trop-2 is an epithelial cell surface antigen overexpressed in UC (Avellini. Oncotarget 2017). Sacituzumab govitecan (SG) is an antibody-drug conjugate that targets Trop-2 and delivers the active metabolite SN38 of the topoisomerase I inhibitor irinotecan to tumor cells (Starodub. Clin Cancer Res 2015). In a phase 1/2…

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Scott Tagawa MD @drscottagawa Of Weill Cornell Medicine and NewYork-Presbyterian Discusses Targeting PSMA: Patients That Have At Least One Bright Image Tend To Have A Better Chance At Responding. BACKROUND: Prostate surface membrane antigen (PSMA) is usually overexpressed in PC and is enriched in castration-resistant tumors. PSMA-TRT is of increasing interest to the field. Many in the field of theranostics have assumed that PSMA uptake on imaging is a pre-requisite for response. We have conducted a number of trials which have incorporated PSMA imaging, but have not selected patients for treatment based upon imaging results and performed an analysis examining…

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Keith T. Flaherty, M.D. Of Array BioPharma Discusses Updated Data From Phase 3 COLUMBUS Trial: Encorafenib Was The Agent Of Interest In This Study, Encorafenib Was Superior To Vemurafenib. BACKROUND: BRAF/MEK-inhibitor combinations have a central role in the treatment of BRAF V600mutant melanoma based on demonstrated benefits on progression-free survival (PFS) and overall survival (OS). Because of these meaningful improvements in outcome, mature landmark analyses of PFS and OS, as well as analyses of some prognostic subgroups, require long-term follow-up. Here we report an updated analysis of OS and other endpoints from the COLUMBUS trial. METHODS: In Part 1 of…

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Neelima Denduluri MD @ndenduluri1 Of US Oncology Research Discusses Updates On Patient Care From ASCO: New Ways To Educate Patients Like Micro-learning Videos, Analysis About Cost-Effective Breast Cancer Screening. Investigators from McKesson, The US Oncology Network (The Network) and US Oncology Research will showcase detailed findings from more than 60 studies during the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting, being held in Chicago from May 31 to June 4, 2019, will bring together more than 32,000 oncology professionals from around the globe. ASCO continues to serve as a meaningful platform for community oncologists…

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Joshua Allen PhD @jallenphd Of Oncoceutics, Inc. Discusses Why Does This Subset Of Patients Respond To ONC201: It Appears To Be Very Effective In This Subset Of The Disease Because Its A Vulnerability Produced By This Mutation. BACKROUND: H3 K27M-mutant glioma is associated with a poor prognosis and there is no effective therapy following radiation. We report the clinical experience with single agent ONC201, the first small molecule DRD2 antagonist in oncology, in adults with recurrent H3 K27M-mutant glioma. METHODS: Twenty-nine adult patients with recurrent H3 K27M-mutant glioma have been treated with single agent ONC201 as of January 20, 2019:…

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Joshua Allen PhD @jallenphd Of Oncoceutics, Inc. Discusses Other Suitable Combinations For This Agent That Could Help More People: Which Combination Makes The Most Sense For A Given Patient Will Depend On What Is Happening In Their Tumor. BACKROUND: H3 K27M-mutant glioma is associated with a poor prognosis and there is no effective therapy following radiation. We report the clinical experience with single agent ONC201, the first small molecule DRD2 antagonist in oncology, in adults with recurrent H3 K27M-mutant glioma. METHODS: Twenty-nine adult patients with recurrent H3 K27M-mutant glioma have been treated with single agent ONC201 as of January 20,…

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Joshua Allen PhD @jallenphd Of Oncoceutics, Inc. Discusses Latest Data For Patients Treated With ONC201 With H3 K27M-Mutant Glioma: Median Onset Of Response Was 3 Months, Median Followup Of Slightly More Than 7 Months.BACKROUND:H3 K27M-mutant glioma is associated with a poor prognosis and there is no effective therapy following radiation. We report the clinical experience with single agent ONC201, the first small molecule DRD2 antagonist in oncology, in adults with recurrent H3 K27M-mutant glioma.METHODS:Twenty-nine adult patients with recurrent H3 K27M-mutant glioma have been treated with single agent ONC201 as of January 20, 2019: 19 patients on NCT03295396; 8 patients on…

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Debra Patt MD @dapattmd Of US Oncology Research Discusses Using A.I. & Predictive Analytics In Healthcare: Will Augment Physicians Decisions As Opposed To Replace Them & Provide Appropriate Choice Architecture. Investigators from McKesson, The US Oncology Network (The Network) and US Oncology Research will showcase detailed findings from more than 60 studies during the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting, being held in Chicago from May 31 to June 4, 2019, will bring together more than 32,000 oncology professionals from around the globe. ASCO continues to serve as a meaningful platform for community…

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Debra Patt MD @dapattmd Of US Oncology Research Discusses Delivering Innovated Care In The Clinic: Innovations Made In The Clinic Have Been Transformative In Terms Of Improving The Quality & Value Of Care For Patients. Investigators from McKesson, The US Oncology Network (The Network) and US Oncology Research will showcase detailed findings from more than 60 studies during the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting, being held in Chicago from May 31 to June 4, 2019, will bring together more than 32,000 oncology professionals from around the globe. ASCO continues to serve as…

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Geraldine O’ Sullivan Coyne, MD, discusses the Phase I Trial fo Murlentamab. Background: Membranous expression of AMHRII is found in ~70% of gynecological tumors. Murlentamab (M) binds with high affinity both AMHRII (at cell membrane) and CD16 (on macrophage, via its low fucose Fc). M reprograms TAMs, restoring their antitumoral functions (phagocytosis) resulting in cytotoxic T cell reactivation. Methods: Pts with advanced/metastatic AMHRII-expressing ovarian, cervical or endometrial cancer with measurable disease and performance status ? 1 received M as single agent (SA) in 8 dose escalating and 2 expansion cohorts. Combination with CP was studied in 2 escalating cohorts. Safety,…

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Geraldine O’ Sullivan Coyne, MD, discusses the Phase I Trial of Murlentamab. Background: Membranous expression of AMHRII is found in ~70% of gynecological tumors. Murlentamab (M) binds with high affinity both AMHRII (at cell membrane) and CD16 (on macrophage, via its low fucose Fc). M reprograms TAMs, restoring their antitumoral functions (phagocytosis) resulting in cytotoxic T cell reactivation. Methods: Pts with advanced/metastatic AMHRII-expressing ovarian, cervical or endometrial cancer with measurable disease and performance status ? 1 received M as single agent (SA) in 8 dose escalating and 2 expansion cohorts. Combination with CP was studied in 2 escalating cohorts. Safety,…

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Scott Koenig, of Macrogenics, discusses what it will take to gain regulatory approval. About MacroGenics, Inc. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website…

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Scott Koenig, of Macrogenics, discusses achieving a better outcome for patients. About MacroGenics, Inc. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com.…

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Scott Koenig discusses the data on the Phase 3 SOPHIA study. About MacroGenics, Inc. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com.…

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Scott Koenig discusses the Phase 3 SOPHIA study. About MacroGenics, Inc. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics and the…

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Yousuf Zafar, MD, discusses the importance of patient care. Financial barriers to clinical trial enrollment are an area of active investigation. Financial toxicity as a concept describes how high costs and financial burden can lead to compromised care and outcomes. Despite the potential to yield large survival benefits and improved access to cutting-edge therapies, less than 5% of adult patients with cancer are enrolled in a clinical trial. Disparities in trial enrollment exist along age, ethnic, and sociodemographic lines, with younger, poorer, nonwhite patients with private insurancethe exact population who may be at highest risk for financial toxicityless likely to…

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Yousuf Zafar, MD, discusses the importance of questioning the qaulity and completenesss of Data. Financial barriers to clinical trial enrollment are an area of active investigation. Financial toxicity as a concept describes how high costs and financial burden can lead to compromised care and outcomes. Despite the potential to yield large survival benefits and improved access to cutting-edge therapies, less than 5% of adult patients with cancer are enrolled in a clinical trial. Disparities in trial enrollment exist along age, ethnic, and sociodemographic lines, with younger, poorer, nonwhite patients with private insurancethe exact population who may be at highest risk…

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Yousuf Zafar, MD, discuses the role of Real World Evidence in cancer care. Financial barriers to clinical trial enrollment are an area of active investigation. Financial toxicity as a concept describes how high costs and financial burden can lead to compromised care and outcomes. Despite the potential to yield large survival benefits and improved access to cutting-edge therapies, less than 5% of adult patients with cancer are enrolled in a clinical trial. Disparities in trial enrollment exist along age, ethnic, and sociodemographic lines, with younger, poorer, nonwhite patients with private insurancethe exact population who may be at highest risk for…

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Dr. Mehool Patel dicusses how artificial intelligence makes an impact on decisions for both clinicians and patients alike. Background: Next generation sequencing (NGS) in hematological tumors is increasingly shaping clinical treatment decisions at the point of care. While the impact of NGS panels in solid tumors is largely therapeutic, targeted sequencing in hematological tumors can additionally provide diagnostic and prognostic insights. Additional data generated in hematological tumor sequencing makes manual interpretation and annotation of variants tedious and non-scalable. In this study we compared hematological tumor variant interpretation using an artificial intelligence decision-support system, Watsonä for Genomics (WfG), with expert guided…

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Rod Humerickhouse discusses the importance of Minimal Residual Disease Negativity. Background: The multinational, open-label, phase 3 CLL14 trial compared fixed-duration targeted VenG treatment with chlorambucil-obinutuzumab (ClbG) in previously untreated pts with CLL and comorbidities. Here we present endpoint analyses with particular emphasis on MRD? and PFS. Methods: Pts with a CIRS score >6 and/or an estimated creatinine clearance <70 mL/min were randomized 1:1 to receive equal duration treatment with 12 cycles (C) of standard Clb or Ven 400 mg daily in combination with G for first 6 C. Primary endpoint was PFS. MRD? in peripheral blood (PB) or bone marrow…

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Rod Humerickhouse discusses the Phase 3 CLL14 Trial. Background: The multinational, open-label, phase 3 CLL14 trial compared fixed-duration targeted VenG treatment with chlorambucil-obinutuzumab (ClbG) in previously untreated pts with CLL and comorbidities. Here we present endpoint analyses with particular emphasis on MRD? and PFS. Methods: Pts with a CIRS score >6 and/or an estimated creatinine clearance <70 mL/min were randomized 1:1 to receive equal duration treatment with 12 cycles (C) of standard Clb or Ven 400 mg daily in combination with G for first 6 C. Primary endpoint was PFS. MRD? in peripheral blood (PB) or bone marrow (BM) 3…

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Dr. Cora Sternberg Of Weill Cornell Medicine and NewYork-Presbyterian discusses the broader implications of the SAUL study. Background: Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic UC based on IMvigor210 and IMvigor211 phase II and III trials. The single-arm SAUL study (NCT02928406) with a broader patient (pt) population demonstrated median overall survival (OS) of 8.7 months and a safety profile consistent with previous atezo trials. Methods: Pts with locally advanced/metastatic UC or non-UC of the urinary tract received atezo 1200 mg every 3 weeks until disease progression or unacceptable toxicity. Populations excluded from IMvigor211 (renal…

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Dr. Cora Sternberg Of Weill Cornell Medicine and NewYork-Presbyterian discusses results of the SAUL study. Background: Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic UC based on IMvigor210 and IMvigor211 phase II and III trials. The single-arm SAUL study (NCT02928406) with a broader patient (pt) population demonstrated median overall survival (OS) of 8.7 months and a safety profile consistent with previous atezo trials. Methods: Pts with locally advanced/metastatic UC or non-UC of the urinary tract received atezo 1200 mg every 3 weeks until disease progression or unacceptable toxicity. Populations excluded from IMvigor211 (renal impairment, ECOG…

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Edward B. Garon discusses what the results of the KEYNOTE-001 mean for the patient. Background: Pembrolizumab (pembro) monotherapy has demonstrated durable antitumor activity in advanced PD-L1expressing NSCLC. We present 5-y OS for patients (pts) enrolled in the phase 1b KEYNOTE-001 study (NCT01295827), the first trial evaluating pembro in advanced NSCLC. These data provide the longest efficacy/safety follow-up for NSCLC pts treated with pembro. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. The primary efficacy…

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Edward B. Garon discusses results from KEYNOTE-001. Background: Pembrolizumab (pembro) monotherapy has demonstrated durable antitumor activity in advanced PD-L1expressing NSCLC. We present 5-y OS for patients (pts) enrolled in the phase 1b KEYNOTE-001 study (NCT01295827), the first trial evaluating pembro in advanced NSCLC. These data provide the longest efficacy/safety follow-up for NSCLC pts treated with pembro. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. The primary efficacy endpoint was ORR. OS was a secondary…

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Dr. Ronald Shcheff, MD, Of Weill Cornell Medicine and NewYork-Presbyterian discusses the results from KEYNOTE-001. Background: Pembrolizumab (pembro) monotherapy has demonstrated durable antitumor activity in advanced PD-L1expressing NSCLC. We present 5-y OS for patients (pts) enrolled in the phase 1b KEYNOTE-001 study (NCT01295827), the first trial evaluating pembro in advanced NSCLC. These data provide the longest efficacy/safety follow-up for NSCLC pts treated with pembro. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. The primary…

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Michael Hall, MD Of Fox Chase Cancer Center Discusses POLO Trial: PFS Increased With Olaparib As Maintenance Therapy For BRCA+ Metastatic Pancreatic Cancer.The PARP inhibitor olaparib (Lynparza) significantly improved progression-free survival (PFS) in patients with germline BRCA-mutated metastatic pancreatic cancer compared to placebo when used as maintenance therapy in the phase III POLO trial, presented at the 2019 ASCO Annual Meeting.1,2Overall, the median PFS was 7.4 months with olaparib versus 3.8 months with placebo (hazard ratio [HR], 0.53; 95% CI, 0.35-0.82; P = .004).This is the first positive phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic…

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Michael Ciesielski, Phd @mjciesielski Of Roswell Park Comprehensive Cancer Center Discusses Latest Data On SurVaxM Vaccine: Doubled Progression Free Period, Patients Are Surviving About 30 Months On Vaccine, Standard Of Care Median Survival Of 15 Months. CHICAGO With their phase II study in patients with aggressive brain cancer now completed, the developers of the cancer immunotherapy SurVaxM are sharing research results at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO), reporting that combination therapy with the vaccine was more effective than standard therapy for nearly all patients. The meeting, which continues through June 4 at McCormick…

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Dr. Joseph Tabernero, MD, discusses the safety profile for Pembrolizumab. Background: KEYNOTE062 (NCT02494583) was a randomized, active controlled study of 1L P or P+C vs C in pts with PD-L1 combined positive score ?1 (CPS ?1), HER2-negative, advanced GC. Methods: Eligible pts were randomized 1:1:1 to P 200 mg Q3W for up to 2 y, P+C (cisplatin 80 mg/m2 + 5-FU 800 mg/m2/d on d1-d5 Q3W [or capecitabine 1000 mg/m2 BID on d1-d14 Q3W per local guideline]) or placebo Q3W + C. Randomization was stratified by region, disease status, and fluoropyrimidine treatment. Primary endpoints were OS in CPS ?1 and…

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Dr. Joseph Tabernero, MD, discusses the phase 3 keynote-062 study. Background: KEYNOTE062 (NCT02494583) was a randomized, active controlled study of 1L P or P+C vs C in pts with PD-L1 combined positive score ?1 (CPS ?1), HER2-negative, advanced GC. Methods: Eligible pts were randomized 1:1:1 to P 200 mg Q3W for up to 2 y, P+C (cisplatin 80 mg/m2 + 5-FU 800 mg/m2/d on d1-d5 Q3W [or capecitabine 1000 mg/m2 BID on d1-d14 Q3W per local guideline]) or placebo Q3W + C. Randomization was stratified by region, disease status, and fluoropyrimidine treatment. Primary endpoints were OS in CPS ?1 and…

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Philadelphia, PA (May 17, 2019) – Oncoceutics, Inc. announced that the latest efficacy data for the use of ONC201 in adult recurrent H3 K27M-mutant glioma will be presented in an Oral Abstract Session at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. In addition, there will be an update on ONC201 in previously irradiated pediatric H3 K27M-mutant glioma that will be presented in a poster session. The oral abstract session presentation, entitled “Single agent ONC201 in adult recurrent H3 K27M-mutant glioma” will describe the clinical experience of ONC201, in adults with recurrent H3 K27M-mutant glioma. It will…

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Shirish Gadgeel MD @umrogelcancer Of University Of Michigan Discusses Update Of KEYNOTE-189 Trial: Evaluated The Addition Of Pembrolizumab To Platinum & Pemetrexed Chemotherapy In Patients With Metastatic Nonsquamous NSCLC.BACKROUND: Pembro + chemo significantly improved OS and PFS over chemo alone and had manageable safety as 1L therapy for metastatic nonsquamous NSCLC in the KEYNOTE-189 study (NCT02578680). The benefit was observed irrespective of PD-L1 TPS. We present updated OS based on longer follow-up and, for the first time, PFS2. METHODS: Eligible pts were randomized 2:1 to pembro (n = 410) or placebo (n = 206) + pemetrexed and carboplatin or cisplatin…

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Shirish Gadgeel MD @umrogelcancer Of University Of Michigan Discusses KEYNOTE-189 Roadmap: Long Term Data & Specific Biomarkers Will Continue To Be Evaluated. BACKROUND: Pembro + chemo significantly improved OS and PFS over chemo alone and had manageable safety as 1L therapy for metastatic nonsquamous NSCLC in the KEYNOTE-189 study (NCT02578680). The benefit was observed irrespective of PD-L1 TPS. We present updated OS based on longer follow-up and, for the first time, PFS2. METHODS: Eligible pts were randomized 2:1 to pembro (n = 410) or placebo (n = 206) + pemetrexed and carboplatin or cisplatin for 4 cycles followed by pembro…

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Shirish Gadgeel MD @umrogelcancer Of University Of Michigan Discusses KEYNOTE-189 Questions: Seen Benefit In PD-L1 0 Tumors, Further Follow Up That Compares Pembrolizumab + Chemo To Pembrolizumab Alone. BACKROUND: Pembro + chemo significantly improved OS and PFS over chemo alone and had manageable safety as 1L therapy for metastatic nonsquamous NSCLC in the KEYNOTE-189 study (NCT02578680). The benefit was observed irrespective of PD-L1 TPS. We present updated OS based on longer follow-up and, for the first time, PFS2. METHODS: Eligible pts were randomized 2:1 to pembro (n = 410) or placebo (n = 206) + pemetrexed and carboplatin or cisplatin…

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… Qing Xu MD Of Shanghai Tenth Hospital Discusses Watson For Oncology (WFO): Developed With AI To Assist Oncologists In Treatment Decision-Making By Providing Evidence-Based Treatment Recommendations. BACKROUND:IBM Watson for Oncology (WFO) is developed with artificial intelligence to assist the oncologists in treatment decision-making by providing evidence-based treatment recommendations with priority and personality. We have been exploring the value of applying WFO in teaching and remote consulting among members in the hospital union to improve medical quality and conformity. METHODS:Four modes were followed to apply WFO to teaching and remote consulting. Firstly, a teaching hospital conducted instructional teaching for a…

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Qing Xu MD Of Shanghai Tenth Hospital Discusses Watson For Oncology (WFO): Developed With AI To Assist Oncologists In Treatment Decision-Making By Providing Evidence-Based Treatment Recommendations. BACKROUND: IBM Watson for Oncology (WFO) is developed with artificial intelligence to assist the oncologists in treatment decision-making by providing evidence-based treatment recommendations with priority and personality. We have been exploring the value of applying WFO in teaching and remote consulting among members in the hospital union to improve medical quality and conformity. METHODS: Four modes were followed to apply WFO to teaching and remote consulting. Firstly, a teaching hospital conducted instructional teaching for…

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Toni Choureiri, MD, discusses the biomarker analyses from JAVELIN Renal 101. Background: The phase 3 JAVELIN Renal 101 trial in previously untreated patients (pts) with aRCC demonstrated a progression-free survival (PFS) benefit and higher objective response rate with A+Ax vs S (Motzer, ESMO 2018; LBA6_PR). Here, we report outcomes from biomarker analyses of baseline tumor samples. Methods: We correlated efficacy with the results of molecular analyses of tissue samples from all 886 pts enrolled in JAVELIN Renal 101. Nephrectomy or tumor samples were characterized by immunohistochemistry (CD8 and PD-L1), whole-exome sequencing (WES), and RNAseq. WES and RNAseq were used to…

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Tina Cascone MD Of The University of Texas MD Anderson Cancer Center Discusses Toxicity Of Nivolumab & Ipilimumab: Were Still Learning How To Leverage These Treatments In The Pre-Operative Setting. BACKROUND: Neoadjuvant immune checkpoint inhibitors (ICIs) induce major pathologic response (MPR) rates of 20 to 45% in resected NSCLCs. We report the results of NEOSTAR – a phase 2 trial of neoadjuvant N or NI for NSCLCs. METHODS: Pts with stage I-IIIA (single N2) resectable NSCLC (AJCC 7th), PS 0-1, were randomized to N (3 mg/kg IV, D1, 15, 29) or N plus I (1 mg/kg IV, D1) followed by…

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Tina Cascone MD Of The University of Texas MD Anderson Cancer Center Discusses Results Of NEOSTAR Study: Study Looked At Neoadjuvant Nivolumab Or Nivolumab Plus Ipilimumab For Resectable NSCLC. BACKROUND: Neoadjuvant immune checkpoint inhibitors (ICIs) induce major pathologic response (MPR) rates of 20 to 45% in resected NSCLCs. We report the results of NEOSTAR – a phase 2 trial of neoadjuvant N or NI for NSCLCs. METHODS: Pts with stage I-IIIA (single N2) resectable NSCLC (AJCC 7th), PS 0-1, were randomized to N (3 mg/kg IV, D1, 15, 29) or N plus I (1 mg/kg IV, D1) followed by surgery…

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Dr. Kristin Higgins, MD, discusses the survival benefit of Durvalumab. Background: In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.4265; P < 0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.530.87; P = 0.00251). Safety was similar and durvalumab had no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients with WHO PS 0/1 (any tumor PD-L1 status) who received…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses Why Is CBX-11 Data Significant: Our Platform Technology Is Specific & Only Delivers The Molecule To The Tumor, Can Go In Combo With High Dose Chemotherapeutic Agents. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS:…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses When Will CBX-11 Enter The Clinic: Clinical Program Starting In January Or February Of 2020. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS: We sought to test the hypothesis that HRD-negative cancers can be effectively…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses What Is Alphalex & How Does It Work: Makes Use Of Acidic Tumor Environment To Deliver Anti Cancer Agents Directly Into The Tumor. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS: We sought to test…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses Strategy Of Alphalex Developement: The Agnostic Nature Of The Platform Allows Us To Bring Therapeutics To A Wider Patient Population. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS: We sought to test the hypothesis that…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses How Is Alphalex Different: Its An Antigen Agnostic Tumor Targeting Technology, Can Target Almost Any Solid Tumor In Theory. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS: We sought to test the hypothesis that HRD-negative…

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Vishwas Paralkar, PhD Of Cybrexa Therapeutics Discusses Cybrexa Additional Candidates: CBX-11 Is The First Of Many Candidates, More Data Will Be Released In The Coming Months. BACKROUND: Poly(ADP-ribose)polymerase inhibitors (PARPis) are a promising new class of anti-cancer agents, but their clinical application has largely been limited to tumors with homologous recombination deficiency (HRD), such as those with BRCA1/2 mutations. One strategy to target HRD-negative tumors with PARPis is to combine them with chemotherapy, although clinical trials indicate that dose-limiting toxicities are a major barrier to achieving synergistic efficacy with these combinations. METHODS: We sought to test the hypothesis that HRD-negative…

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Dr. Sanjay Popat, PhD, dicusses Health-related quality of life results from ALTA-1. Background: Results from ALTA-1L (NCT02737501), an international, multicenter trial, showed that brigatinib vs crizotinib as 1L ALK therapy significantly prolongs progression-free survival (PFS; HR: 0.49, 95% CI, 0.33, 0.74) in advanced ALK+ NSCLC. HRQoL was evaluated as a secondary objective. Methods: ALK+ NSCLC patients were randomized 1:1 to brigatinib 90 mg daily for 7 days, then 180 mg daily or crizotinib 250 mg twice daily as 1L ALK therapy; treatment cycles were 28 days. HRQoL was assessed with the EORTC QLQ-C30 and LC13. Change from baseline, duration of…

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Dr. Kristin Higgins, MD, discusses how radiation was given in the PACIFIC trials. Background: In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.4265; P < 0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.530.87; P = 0.00251). Safety was similar and durvalumab had no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients with WHO PS 0/1 (any tumor PD-L1…

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Dr. Kristin Higgins, MD, disucsses the three-year overall survival update from the PACIFIC trial.Background: In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.4265; P < 0.0001) and overall survival (OS; HR, 0.68; 95% CI, 0.530.87; P = 0.00251). Safety was similar and durvalumab had no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study. Methods: Patients with WHO PS 0/1 (any tumor PD-L1…

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Michael R. Migden, M.D., discusses locally advanced cutaneous squamous cell carcinoms. Background: Cemiplimab (REGN2810) produced substantial antitumor activity with durable responses in Phase 1 CSCC expansion cohorts and Phase 2 metastatic (m) CSCC cohort. We now present the primary analysis of the Phase 2 laCSCC cohort (NCT02760498; data cutoff date: Oct 10, 2018). Methods: Pts with laCSCC received cemiplimab 3 mg/kg IV every 2 weeks (Q2W). Tumor measurements were performed Q8W. The primary objective was to evaluate objective response rate (ORR; complete response [CR] + partial response [PR]) according to independent central review (per RECIST 1.1 for scans; modified WHO…

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Michael R. Migden, M.D., discusses the phase 2 results of Cemiplimab. Background: Cemiplimab (REGN2810) produced substantial antitumor activity with durable responses in Phase 1 CSCC expansion cohorts and Phase 2 metastatic (m) CSCC cohort. We now present the primary analysis of the Phase 2 laCSCC cohort (NCT02760498; data cutoff date: Oct 10, 2018). Methods: Pts with laCSCC received cemiplimab 3 mg/kg IV every 2 weeks (Q2W). Tumor measurements were performed Q8W. The primary objective was to evaluate objective response rate (ORR; complete response [CR] + partial response [PR]) according to independent central review (per RECIST 1.1 for scans; modified WHO…

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Karen Reckamp MD @KarenReckampMD Of City of Hope Discusses Who Should We Test: Theres No Screening Study That Has Been Shown To Help Improve Finding The Cancer Early In Non Smokers. BACKROUND: Eligibility for lung cancer screening is based largely on pack-years of smoking, missing many cases. To propose additional groups for screening, this observational study evaluated whether germline mutations associated with cancer risk accelerate onset of lung adenocarcinoma (LA) in ever- and never-smokers. METHODS: Patients with LA and family history of cancer were recruited from our oncology clinic and the Clinical Cancer Genomics Community Research Network. With consent, blood…

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Karen Reckamp MD @KarenReckampMD Of City of Hope Discusses Lung Cancer On The Rise: Understanding Why People Are Getting Diagnosed At Earlier Ages Is Important For Prevention & Cure. BACKROUND: Eligibility for lung cancer screening is based largely on pack-years of smoking, missing many cases. To propose additional groups for screening, this observational study evaluated whether germline mutations associated with cancer risk accelerate onset of lung adenocarcinoma (LA) in ever- and never-smokers. METHODS: Patients with LA and family history of cancer were recruited from our oncology clinic and the Clinical Cancer Genomics Community Research Network. With consent, blood samples were…

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Karen Reckamp MD @KarenReckampMD Of City of Hope Discusses Germline Mutations In Patients With Lung Cancer: Study Had 104 Patients Who Were Non Smokers & 65 Who Smoked, Looked At 4 Categories Of Germline Gene Mutation. BACKROUND: Eligibility for lung cancer screening is based largely on pack-years of smoking, missing many cases. To propose additional groups for screening, this observational study evaluated whether germline mutations associated with cancer risk accelerate onset of lung adenocarcinoma (LA) in ever- and never-smokers. METHODS: Patients with LA and family history of cancer were recruited from our oncology clinic and the Clinical Cancer Genomics Community…

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Dr. Paul Paik, MD, discusses the future of Tepotinib. Background: MET exon 14 skipping (METex14) mutations – reported in 3~4% of NSCLC patients (pts) – are activating, sensitive to MET inhibition and can be conveniently detected using liquid biopsy (LBx). We report data from an ongoing single-arm phase II study of tepotinib, a highly selective MET inhibitor, in NSCLC pts with METex14 mutations identified by LBx or tumor biopsy (TBx) (NCT02864992). Methods: Pts with advanced WT EGFR/ALK NSCLC, prospectively enrolled via either LBx (?60 pts) or TBx (?60 pts, overlap anticipated) central RNA-based METex14 mutation testing, receive tepotinib 500 mg…

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Dr. Paul K. Paik, MD, on the Phase II study of Tepotinib. Background: MET exon 14 skipping (METex14) mutations – reported in 3~4% of NSCLC patients (pts) – are activating, sensitive to MET inhibition and can be conveniently detected using liquid biopsy (LBx). We report data from an ongoing single-arm phase II study of tepotinib, a highly selective MET inhibitor, in NSCLC pts with METex14 mutations identified by LBx or tumor biopsy (TBx) (NCT02864992). Methods: Pts with advanced WT EGFR/ALK NSCLC, prospectively enrolled via either LBx (?60 pts) or TBx (?60 pts, overlap anticipated) central RNA-based METex14 mutation testing, receive…

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Dr. Sanjay Popat discusses the quality of life for patients using Brigatinib. Background: Results from ALTA-1L (NCT02737501), an international, multicenter trial, showed that brigatinib vs crizotinib as 1L ALK therapy significantly prolongs progression-free survival (PFS; HR: 0.49, 95% CI, 0.33, 0.74) in advanced ALK+ NSCLC. HRQoL was evaluated as a secondary objective. Methods: ALK+ NSCLC patients were randomized 1:1 to brigatinib 90 mg daily for 7 days, then 180 mg daily or crizotinib 250 mg twice daily as 1L ALK therapy; treatment cycles were 28 days. HRQoL was assessed with the EORTC QLQ-C30 and LC13. Change from baseline, duration of…

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Dr. Michael Atkins MD Of Georgetown University Discusses Who Should Get Ipi:Nivo VS NIVO Monotherapy: Patients With Elevated LDH, BRAF Mutant Tumors, & Brain Metastases Benefit From Combination Therapy. BACKROUND: We previously reported a 3-year overall survival (OS) rate of 63% with NIVO+IPI concurrent therapy in the initial phase I dose-escalation study for the combination, conducted in patients (pts) with advanced melanoma. Here, we report OS after 5 years of overall study follow-up and assess survival rates after stopping treatment. METHODS: Adults with previously treated or untreated unresectable stage III or IV melanoma, and ECOG performance status of 0 or…

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Dr. Michael Atkins MD Of Georgetown University Discusses CHECKMATE-004 Trial Results: 57% Of Patients Were Alive At 4 Years, Treatment Plan Was 2 Years, 23 Patients Completed Full Course. BACKROUND: We previously reported a 3-year overall survival (OS) rate of 63% with NIVO+IPI concurrent therapy in the initial phase I dose-escalation study for the combination, conducted in patients (pts) with advanced melanoma. Here, we report OS after 5 years of overall study follow-up and assess survival rates after stopping treatment. METHODS: Adults with previously treated or untreated unresectable stage III or IV melanoma, and ECOG performance status of 0 or…

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Dr. Sanjay Popat discusses if East Asian patients tolerate Brigatinib any differently than Crizotinb. Background: We report an analysis of BRG vs CRZ in Asian vs non-Asian pts with ALK inhibitornaive, ALK+ NSCLC from ALTA-1L (NCT02737501). Methods: Pts were randomized 1:1 to BRG 180 mg QD (7-day lead-in at 90 mg) or CRZ 250 mg BID. Primary endpoint: blinded independent review committee (BIRC)-assessed PFS (RECIST v1.1). Secondary efficacy endpoints: BIRC-assessed ORR, intracranial (i) ORR, and iPFS. Results: 275 pts were randomized; 108 Asian (BRG/CRZ, n = 59/49), 167 non-Asian (n = 78/89); median age: Asian, 55/56 y; non-Asian, 60/60 y.…

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Elad Sharon MD @EladSharonMD Of The National Cancer Institute Discusses Pembrolizumab Trial & Broadening Eligibility For HIV Patients: Patients With HIV Did Very Well With Pembrolizumab, The NCI Has Been Pushing To Broaden Eligibility. BACKROUND: People with HIV have been excluded from immuno-oncology (IO) studies. Anti- PD-1/PD-L1 therapies are approved for a growing number of cancers. We evaluated pembrolizumab (pembro) in people with HIV and cancer. METHODS: CITN-12 is a multicenter phase 1 trial. Key eligibility: advanced cancer; ECOG ?1; CD4 ?100 cells/?L; ?4 weeks antiretroviral therapy (ART), HIV viral load (VL) < 200 copies/mL. Exclusion: uncontrolled HBV/HCV, autoimmune disease.…

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Dr. Sanjay Popat, PhD, disucsses the Phase 3 ALTA-1L sub-analyses. Background: We report an analysis of BRG vs CRZ in Asian vs non-Asian pts with ALK inhibitornaive, ALK+ NSCLC from ALTA-1L (NCT02737501). Methods: Pts were randomized 1:1 to BRG 180 mg QD (7-day lead-in at 90 mg) or CRZ 250 mg BID. Primary endpoint: blinded independent review committee (BIRC)-assessed PFS (RECIST v1.1). Secondary efficacy endpoints: BIRC-assessed ORR, intracranial (i) ORR, and iPFS. Results: 275 pts were randomized; 108 Asian (BRG/CRZ, n = 59/49), 167 non-Asian (n = 78/89); median age: Asian, 55/56 y; non-Asian, 60/60 y. 32/24% of Asians vs…

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Katja Weisel from University Medical Center Hamburg-Eppendorf discusses the role of daratumumab in first line treatment. Background: MM patients (pts) with high cytogenetic risk have poor outcomes. In CASTOR, D-Vd prolonged progression-free survival (PFS) vs bortezomib and dexamethasone (Vd) alone, and exhibited tolerability in RRMM pts. We conducted a subgroup analysis of D-Vd vs Vd in CASTOR, based on cytogenetic risk. Methods: Pts received ?1 prior line of therapy. Cytogenetic risk was based on a combined analysis of next-generation sequencing (NGS) and fluorescence in situ hybridization/karyotype testing. High-risk pts had t(4;14), t(14;16), or del17p abnormalities. Standard (std)-risk pts were confirmed…

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Katja Weisel from the University Medical Center Hamburg-Eppendorf discusses the efficacy and safety of daratumumab, bortezomib, and dexamethasone. Background: MM patients (pts) with high cytogenetic risk have poor outcomes. In CASTOR, D-Vd prolonged progression-free survival (PFS) vs bortezomib and dexamethasone (Vd) alone, and exhibited tolerability in RRMM pts. We conducted a subgroup analysis of D-Vd vs Vd in CASTOR, based on cytogenetic risk. Methods: Pts received ?1 prior line of therapy. Cytogenetic risk was based on a combined analysis of next-generation sequencing (NGS) and fluorescence in situ hybridization/karyotype testing. High-risk pts had t(4;14), t(14;16), or del17p abnormalities. Standard (std)-risk pts…

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Background: MM patients (pts) with high cytogenetic risk have poor outcomes. In CASTOR, D-Vd prolonged progression-free survival (PFS) vs bortezomib and dexamethasone (Vd) alone, and exhibited tolerability in RRMM pts. We conducted a subgroup analysis of D-Vd vs Vd in CASTOR, based on cytogenetic risk. Methods: Pts received ?1 prior line of therapy. Cytogenetic risk was based on a combined analysis of next-generation sequencing (NGS) and fluorescence in situ hybridization/karyotype testing. High-risk pts had t(4;14), t(14;16), or del17p abnormalities. Standard (std)-risk pts were confirmed negative for all 3 abnormalities. Minimal residual disease (MRD; 105) was assessed via NGS using clonoSEQ…

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Lee Schwartzberg MD @oncstatdoc Of West Cancer Center Discusses Prophylaxis For CINV: Patients Should Be Treated With A Triple Combination To Get The Best Prophylaxis Against CINV. BACKROUND: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and…

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Lee Schwartzberg MD @oncstatdoc Of West Cancer Center Discusses Managing CINV: Developed New NK1 Receptor Antagonist, Clear Evidence Based Guidelines That Tell When To Use Triplet Or Double Combination. BACKROUND: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity…

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Lee Schwartzberg MD @oncstatdoc Of West Cancer Center Discusses Issues With CINV Remaining: If Guidelines Are Used Effectively A Large Majority Of Patients Will Not Have A Severe CINV Reaction. BACKROUND: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast,…

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Lee Schwartzberg MD @oncstatdoc Of West Cancer Center Discusses Intravenous NEPA Study: Combination Therapy To Prevent CINV In Patients Receiving Anthracycline/Cyclophosphamide (AC). BACKROUND: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with…

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Lee Schwartzberg MD @oncstatdoc Of West Cancer Center Discusses Akynzeo: Convient & Flexible Dosing, Can Be Given Orally & Intravenously. BACKROUND: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant,…

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Earn CME: https://naccme.com/program/7331 In this presentation from the ‘Looking to the Future With Hope: Advances in the Treatment of AML’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Mojtaba Akhtari discusses a patient case to examine whether transplant, conventional therapy, or novel targeted is most appropriate for the MRD+ patient subset and in what conditions. © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7331 In this presentation from the ‘Looking to the Future With Hope: Advances in the Treatment of AML’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Daniel A. Pollyea provides an update on the latest advances in the treatment of acute myeloid leukemia (AML). © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7330 In this presentation from the ‘CLL in the Era of Targeted Therapy’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Richard R. Furman utilizes a case presentation to examine personalized management strategies for relapsed/refractory, high risk patients with CLL. © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7330 In this presentation from the ‘CLL in the Era of Targeted Therapy’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Jacqueline C. Barrientos discusses therapeutic sequencing in CLL patients, with a focus on mono vs. combination therapy. © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7330 In this presentation from the ‘CLL in the Era of Targeted Therapy’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Richard R. Furman discusses novel agents and treatment strategies for patients with chronic lymphocytic leukemia (CLL). © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7329 In this presentation from the ‘Minimal Residual Disease (MRD) Testing in Multiple Myeloma’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Prashant Kapoor agues against using MRD as the primary treatment target for patients with multiple myeloma. © 2019 Imedex, an HMP Company

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Earn CME: https://naccme.com/program/7329 In this presentation from the ‘Minimal Residual Disease (MRD) Testing in Multiple Myeloma’ symposium at the 2019 Great Debates & Updates in Hematologic Malignancies in New York, Dr. Prashant Kapoor agues that MRD should be the treatment target for patients with multiple myeloma. © 2019 Imedex, an HMP Company

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Douglas S. Hawkins MD Of The University of Washington School of Medicine Discusses Questions About Larotrectinib: Who Should Be Tested, How Long Should They Be Treated, What Agent To Use BACKROUND: TRK fusions involving NTRK1, NTRK2, and NTRK3 genes have been identified in a broad range of pediatric and adult malignancies. Larotrectinib, a highly-selective oral TRK inhibitor, was well tolerated and showed encouraging antitumor activity in 17 pediatric patients (pts) with TRK fusion cancer (Laetsch et al, Lancet Oncol 2018). Here, we present data on the clinical efficacy and safety of larotrectinib in 38 pediatric pts with TRK fusion cancer…

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Douglas S. Hawkins MD Of The University of Washington School of Medicine Discusses Larotrectinib Efficacy & Safety In Pediatric TRK Fusion Cancer Patients: 94% Of The Children Treated With Larotrectinib Achieved A Response. BACKROUND: TRK fusions involving NTRK1, NTRK2, and NTRK3 genes have been identified in a broad range of pediatric and adult malignancies. Larotrectinib, a highly-selective oral TRK inhibitor, was well tolerated and showed encouraging antitumor activity in 17 pediatric patients (pts) with TRK fusion cancer (Laetsch et al, Lancet Oncol 2018). Here, we present data on the clinical efficacy and safety of larotrectinib in 38 pediatric pts with…

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Douglas S. Hawkins MD Of The University of Washington School of Medicine Discusses How To Identify Patients With An NTRK Gene Fusion: Will Require A Very Broad Genomic Sequencing. BACKROUND: TRK fusions involving NTRK1, NTRK2, and NTRK3 genes have been identified in a broad range of pediatric and adult malignancies. Larotrectinib, a highly-selective oral TRK inhibitor, was well tolerated and showed encouraging antitumor activity in 17 pediatric patients (pts) with TRK fusion cancer (Laetsch et al, Lancet Oncol 2018). Here, we present data on the clinical efficacy and safety of larotrectinib in 38 pediatric pts with TRK fusion cancer from…

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Matthew Galsky, MD, Director of Genitourinary Medical Oncology At The Tisch Cancer Institute at Mount Sinai Discusses HCRN GU14-182: Randomized Double-Blind Phase II Study Of Maintenance Pembrolizumab VS Placebo After First-Line Chemotherapy In Patients with mUC. BACKROUND: Platinum-based chemotherapy for 1st-line treatment of pts with metastatic urothelial cancer (mUC) is typically administered for a fixed duration followed by observation until recurrence. PD-1 blockade with pembro improves survival of pts with mUC progressing despite platinum-based chemotherapy. We explored the potential benefit of earlier use of PD-1 blockade using a “switch maintenance” approach. METHODS: Pts with mUC achieving at least stable disease…

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Matthew Galsky, MD, Director of Genitourinary Medical Oncology At The Tisch Cancer Institute at Mount Sinai Discusses HCRN GU14-182 Questions: OS Is The Endpoint Needed To See To Impact Practice, Phase 3 Study Will Answer Future Questions. BACKROUND: Platinum-based chemotherapy for 1st-line treatment of pts with metastatic urothelial cancer (mUC) is typically administered for a fixed duration followed by observation until recurrence. PD-1 blockade with pembro improves survival of pts with mUC progressing despite platinum-based chemotherapy. We explored the potential benefit of earlier use of PD-1 blockade using a “switch maintenance” approach. METHODS: Pts with mUC achieving at least stable…

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Philippe Moreau, MD Of Nantes Faculty of Medicine Discusses Daratumumab Phase 3 Study: Could Be A Pivotal Study In The Approval Of Daratumumab In The United States, Europe, & Other Countries. BACKROUND: VTd is a standard of care (SoC) for TE NDMM. CD38 mAb DARA significantly reduced the risk of progression/death and improved CR and MRD-negative rates in relapsed refractory MM or transplant-ineligible NDMM in phase 3 studies. We report the primary and final analysis of Part 1 of CASSIOPEIA. METHODS: In Part 1, TE NDMM pts 18-65 y were randomized 1:1 to VTd (6 28-day cycles [C; 4 pre-ASCT…

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Philippe Moreau, MD Of Nantes Faculty of Medicine Discusses Daratumumab Phase 3 Study: Phase 3 Randomized Study Of Daratumumab + Bortezomib:Thalidomide:Dexamethasone (D-VTd) VS VTd In Transplant-Eligible NDMM. BACKROUND: VTd is a standard of care (SoC) for TE NDMM. CD38 mAb DARA significantly reduced the risk of progression/death and improved CR and MRD-negative rates in relapsed refractory MM or transplant-ineligible NDMM in phase 3 studies. We report the primary and final analysis of Part 1 of CASSIOPEIA. METHODS: In Part 1, TE NDMM pts 18-65 y were randomized 1:1 to VTd (6 28-day cycles [C; 4 pre-ASCT induction, 2 post-ASCT consolidation]…

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Kim Nguyen Chi MD Of The University Of British Colombia Discusses TITAN Study & Docetaxel: There Is Some Support To Using Apalutamide After Patients Received Docetaxel. BACKROUND: TITAN was designed to determine whether APA, a selective next-generation androgen receptor inhibitor, plus ADT improves radiographic progression-free survival (rPFS) and overall survival (OS) compared with PBO plus ADT in pts with mCSPC. METHODS: In this randomized, double-blind phase 3 study, pts with mCSPC regardless of extent of disease were randomized (1:1) to APA (240 mg/d) or PBO, added to ADT, in 28-day cycles. Pts with prior treatment (tx) for localized disease or…

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Kim Nguyen Chi MD Of The University Of British Colombia Discusses TITAN Study: Phase III Double-Blind, Randomized Study Of Apalutamide Versus Placebo In Patients With (mCSPC). BACKROUND: TITAN was designed to determine whether APA, a selective next-generation androgen receptor inhibitor, plus ADT improves radiographic progression-free survival (rPFS) and overall survival (OS) compared with PBO plus ADT in pts with mCSPC. METHODS: In this randomized, double-blind phase 3 study, pts with mCSPC regardless of extent of disease were randomized (1:1) to APA (240 mg/d) or PBO, added to ADT, in 28-day cycles. Pts with prior treatment (tx) for localized disease or…

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Dr. Luis Paz-Ares, MD, Phd of the Hospital Universitario 12 De Octubre gives a brief overview of his ASCO 2019 presentation in Spanish entitled Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. Abstract: Background: Lurbinectedin (L) is a novel anticancer drug that inhibits activated transcription and induces DNA double-strand breaks, leading to apoptosis. Methods: A multicenter phase 2 basket trial assessed the efficacy and safety of L in several cancer types, including small cell lung cancer (SCLC). Primary endpoint was confirmed overall response rate (ORR) by RECIST v.1.1. In the SCLC…

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Dr. Luiz Paz-Ares, MD, Phd of th Hospital Universitario 12 De Octubre gives a brief overview of his presentation from ASCO 2019 entitiled Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. Abstract: Background: Lurbinectedin (L) is a novel anticancer drug that inhibits activated transcription and induces DNA double-strand breaks, leading to apoptosis. Methods: A multicenter phase 2 basket trial assessed the efficacy and safety of L in several cancer types, including small cell lung cancer (SCLC). Primary endpoint was confirmed overall response rate (ORR) by RECIST v.1.1. In the SCLC cohort,…

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Josep Llovet, MD Of Mount Sinai School of Medicine Discusses Ramucirumab For Sorafenib Intolerant Patients With HCC: 8 Month Median Survival For Ramucirumab & Improved Quality Of Life, Now Approved By FDA. BACKROUND: Len, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor ?, RET, and KIT, is approved for first-line treatment of unresectable HCC (uHCC) based on the open-label phase 3 REFLECT study in which len showed noninferior overall survival (OS) and significantly improved objective response rate (ORR), progression-free survival (PFS), and time-to-progression (TTP) vs sorafenib. In the phase 2 KEYNOTE-224 study of pembro (a PD-1 inhibitor)…

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Josep Llovet, MD Of Mount Sinai School of Medicine Discusses Ramucirumab Study: Good Safety Profile & Patients With Aggressive Tumors Respond Certainly To RAM. BACKROUND: Len, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor ?, RET, and KIT, is approved for first-line treatment of unresectable HCC (uHCC) based on the open-label phase 3 REFLECT study in which len showed noninferior overall survival (OS) and significantly improved objective response rate (ORR), progression-free survival (PFS), and time-to-progression (TTP) vs sorafenib. In the phase 2 KEYNOTE-224 study of pembro (a PD-1 inhibitor) as second-line treatment of advanced HCC, pembro showed…

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Josep Llovet, MD Of Mount Sinai School of Medicine Discusses When To Use Ramucirumab: Second Line & Aggressive Tumors, Moving To Frontline In Combination With TKIs Next. BACKROUND: Len, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor ?, RET, and KIT, is approved for first-line treatment of unresectable HCC (uHCC) based on the open-label phase 3 REFLECT study in which len showed noninferior overall survival (OS) and significantly improved objective response rate (ORR), progression-free survival (PFS), and time-to-progression (TTP) vs sorafenib. In the phase 2 KEYNOTE-224 study of pembro (a PD-1 inhibitor) as second-line treatment of advanced…

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Alexa Schrock, PhD, of Foundation Medicine Discusses High Microsatellite Instability (MSI-H) in Colorectal Carcinoma Study: Tumor mutational burden is predictive of response to immune checkpoint inhibitors in MSI-high metastatic colorectal cancer. This study, published in Annals of Oncology, shows that tumor mutational burden (TMB) may help inform treatment decisions for MSI-H metastatic colorectal cancer patients. In the study, researchers found that TMB appears to be an important biomarker within this subset of patients and may be a predictor for whether these patients will respond to immunotherapy. The study supports the idea that further stratifying MSI-H metastatic colorectal cancer patients based…

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Alexa Schrock PhD Of Foundation Medicine Discusses How To Act On TMB Score: Patients Might Need A Higher TMB To Have a Great Response. BACKROUND: Microsatellite instability (MSI) is a biomarker for response to immune checkpoint inhibitors (ICPIs). PD-1 inhibitors in metastatic colorectal carcinoma (mCRC) with MSI-high (MSI-H) have demonstrated a high disease control rate and favorable progression-free survival (PFS); however, reported response rates to pembrolizumab and nivolumab are variable and often <50%, suggesting that additional predictive biomarkers are needed. METHODS: Clinicopathologic data were collected from patients with MSI-H mCRC confirmed by hybrid capture-based next-generation sequencing (NGS) treated with PD-1/L1…

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Dr. Celestia Higano, MD from the University of Washington discusses the PEACE III Trial Decreased Fracture Rate by Mandating Bone-protecting Agents in the EORTC 1333 Background: Skeletal fractures, pathological or not, are a frequent and underestimated side-effect of systemic treatment of metastatic castration resistant prostate cancer (mCRPC). The ERA223 trial (NCT02043678) was recently unblinded following the report of a significant increase in the fracture rates when abiraterone is combined with Ra223. Hence, FDA and EMA advised against this combination. The question whether mandated use of bone protecting agents (BPA), zoledronic acid or denosumab, would have mitigated the fracture risk and…

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Dr. Celestia Higano, MD of the University of Washington discusses the Alliance A031201 a phase III trial of enzalutamide (ENZ) versus enzalutamide, abiraterone, and prednisone (ENZ/AAP) for metastatic castration resistant prostate cancer (mCRPC) Background: Androgen receptor (AR) signaling is an important growth mechanism in mCRPC, providing the rationale for treatment with AR axis inhibitors such as ENZ and AAP. Targeting AR with anti-androgens such as ENZ can result in compensatory autocrine and paracrine androgenic stimulation. Therefore, using ENZ with the androgen biosynthesis inhibitor AAP to dampen these resistance mechanisms could improve clinical outcomes relative to ENZ alone. Methods: Men with…

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Dr. Celestia Higano, MD of the University of Washington discusses the Titan Trial Apalutamide vs Placebo During Androgen-Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer. At 22.6-month follow-up, 66% of patients in the apalutamide group and 46% of patients in the placebo group remained on treatment. Apalutamide improved radiographic progression-free survival (hazard ratio [HR] = 0.48, 95% confidence interval [CI] = 0.390.60; P < .0001), with a 52% reduction in risk of death or radiographic progression; that benefit was observed across all subgroups analyzed. The median radiographic progression-free survival was not reached in the apalutamide group and was 22.1 months in…

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David M. Cognetti MD @KimmelCancerCtr Of Sidney Kimmel Cancer Center Discusses Photoimmunotherapy (PIT) Phase 2 Study Results: 30 Patients With A 43 ORR & OS Of 9.2 Months, Phase 3 Study Is Being Fast-Tracked. BACKGROUND: Patients with rHNSCC who have failed standard of care have poor prognoses and limited therapeutic options. In this study, final results are reported of a phase 2a trial of photoimmunotherapy (PIT) with a targeted drug RM-1929, consisting of the EGFR-directed antibody cetuximab conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells followed by photoactivation with nonthermal red light induces…

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David M. Cognetti MD @KimmelCancerCtr Of Sidney Kimmel Cancer Center Discusses Photoimmunotherapy (PIT) Phase 2 Study: Multicenter, Open-Label, Study Of RM-1929 Photoimmunotherapy (PIT) In Patients With Locoregional, Recurrent Head & Neck Squamous Cell Carcinoma (rHNSCC). BACKGROUND: Patients with rHNSCC who have failed standard of care have poor prognoses and limited therapeutic options. In this study, final results are reported of a phase 2a trial of photoimmunotherapy (PIT) with a targeted drug RM-1929, consisting of the EGFR-directed antibody cetuximab conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells followed by photoactivation with nonthermal red light…

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David M. Cognetti MD @KimmelCancerCtr Of Sidney Kimmel Cancer Center Discusses Photoimmunotherapy (PIT) Phase 3 Study: Opening Now To Compare Directly To Standard Of Care Chemotherapy. BACKGROUND: Patients with rHNSCC who have failed standard of care have poor prognoses and limited therapeutic options. In this study, final results are reported of a phase 2a trial of photoimmunotherapy (PIT) with a targeted drug RM-1929, consisting of the EGFR-directed antibody cetuximab conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells followed by photoactivation with nonthermal red light induces selective and rapid necrosis of the cancer cells,…

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David M. Cognetti MD @KimmelCancerCtr Of Sidney Kimmel Cancer Center Discusses Photoimmunotherapy (PIT): Superior To Photodynamic Therapy Due To The Light Sensitizer Being Conjugated To Erbitux. BACKGROUND: Patients with rHNSCC who have failed standard of care have poor prognoses and limited therapeutic options. In this study, final results are reported of a phase 2a trial of photoimmunotherapy (PIT) with a targeted drug RM-1929, consisting of the EGFR-directed antibody cetuximab conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells followed by photoactivation with nonthermal red light induces selective and rapid necrosis of the cancer cells,…

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David M. Cognetti MD @KimmelCancerCtr Of Sidney Kimmel Cancer Center Discusses Photoimmunotherapy Technology: Very Straight forward From A Technical Standpoint, 5 Minutes Per Light Application, Tumor Necrosis Seen Within Hours. BACKGROUND: Patients with rHNSCC who have failed standard of care have poor prognoses and limited therapeutic options. In this study, final results are reported of a phase 2a trial of photoimmunotherapy (PIT) with a targeted drug RM-1929, consisting of the EGFR-directed antibody cetuximab conjugated to a photoactivatable dye (IRDye 700DX). Binding of the antibody-dye conjugate to cancer cells followed by photoactivation with nonthermal red light induces selective and rapid necrosis…

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Luis G. Paz-Ares, MD, Phd provides an overview of his presentation at ASCO 2019 entitled Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. In addition, two experts (Rafael Santana-Davila MD of Seattle Cancer Care Alliance and Taofeek Owonikoko MD, PhD, MSCR of the Emory Winship Cancer Institute) give their opinions and a roundtable discussion of the data. Author(s): Luis G. Paz-Ares, Jose Manuel Trigo Perez, Benjamin Besse, Victor Moreno, Rafael Lopez, Maria Angeles Sala, Santiago Ponce Aix, Cristian Marcelo Fernandez, Mariano Siguero, Carmen Maria Kahatt, Ali Hassan Zeaiter, Khalil Zaman, Valentina…

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Luis G. Paz-Ares, MD, Phd provides an overview of his presentation at ASCO 2019 entitled Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. In addition, two experts (Rafael Santana-Davila MD of Seattle Cancer Care Alliance and Taofeek Owonikoko MD, PhD, MSCR of the Emory Winship Cancer Institute) give their opinions and a roundtable discussion of the data. Author(s): Luis G. Paz-Ares, Jose Manuel Trigo Perez, Benjamin Besse, Victor Moreno, Rafael Lopez, Maria Angeles Sala, Santiago Ponce Aix, Cristian Marcelo Fernandez, Mariano Siguero, Carmen Maria Kahatt, Ali Hassan Zeaiter, Khalil Zaman, Valentina…

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Ahmad Tarhini Md, PhD of the Winship Cancer Center discusses the United States Intergroup E1609 A phase III randomized study of adjuvant ipilimumab 3 or 10 mg kg versus high-dose interferon-?2b for resected high-risk melanoma. Background: Phase III adjuvant trials reported significant benefits in relapse-free survival (RFS) for 6 FDA-approved regimens and overall survival (OS) for HDI and ipi10 versus observation or placebo. E1609 evaluated the relative safety and efficacy of ipi at 3 and 10 mg/kg compared to HDI, which was the adjuvant standard until recently. Methods: E1609 had 2 co-primary endpoints: OS and RFS; considered positive if either…

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Charles Craddock MD PhD @charliecraddock of Queen Elizabeth Hospital discusses the Combination Lenalidomide and Azacitidine: A Novel Salvage Therapy in Patients Who Relapse After Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia ABSTRACT PURPOSE Salvage options for patients who relapse after allogeneic stem-cell transplantation (allo-SCT) for acute myeloid leukemia (AML) and myelodysplasia (MDS) remain limited, and novel treatment strategies are required. Both lenalidomide (LEN) and azacitidine (AZA) possess significant antitumor activity effect in AML. Administration of LEN post-transplantation is associated with excessive rates of graft-versus-host disease (GVHD), but AZA has been shown to ameliorate GVHD in murine transplantation models. We therefore…

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Marcus Butler, MD discusses TBI-1301-Effect of minimal lymphodepletion prior to ACT with TBI-1301, NY-ESO-1 specific gene-engineered TCR-T cells, on clinical responses and CRS Background: Adoptive transfer of T cell receptor (TCR) gene-engineered T cells can induce durable anti-cancer responses. Post-infusion cytokine release syndrome (CRS) has been associated with clinical utility. Pre-infusion lymphodepletion (LD) may influence CRS, graft persistence, and clinical responses. While the optimal LD regimen is not yet defined, most include both cyclophosphamide (CY) and fludarabine (FLU). TBI-1301 is a novel gene therapy produced by engineering autologous lymphocytes to express an NY-ESO-1-specific TCR using a retrovirus vector that encodes…

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Marcus Butler, MD of Princess Margaret Cancer Centre discusses the ILLUMINATE 301 A randomized phase 3 study of tilsotolimod in combination with ipilimumab compared with ipilimumab alone in patients with advanced melanoma following progression on or after anti-PD-1 therapy Background: Tilsotolimod (IMO-2125) is a Toll-like receptor (TLR) 9 agonist with potent immunostimulating activity. In an ongoing Phase 1/2 clinical study in patients with advanced melanoma who progressed on or after anti-PD-1 therapy (NCT02644967), intratumoral (IT) tilsotolimod with ipilimumab was well-tolerated, demonstrating durable responses (including complete response > 21 months), dendritic cell activation, type I interferon response, CD8+ T-cell proliferation in…

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Philadelphia, PA (May 7, 2019) – Oncoceutics announced that the US Food and Drug Administration invited the company to present information regarding its lead compound ONC201 at the public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 20, 2019.   The meeting will provide Oncoceutics with the opportunity to present its clinical data for patients treated with ONC201, including studies for both adult and pediatric patients with gliomas containing the H3 K27M mutation, a disease that has been recognized to be an area of high unmet medical need. Additionally, the meeting will enable Oncoceutics…

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GRACE – Global Resource for Advancing Cancer Education Published on Feb 14, 2017 Dr. Luis Raez, MD FACP FCCP, Chief of Hematology/Oncology and Medical Director at Memorial Cancer Institute, and Clinical Associate Professor of Medicine at Florida International University joined GRACE to discuss the basics of lung cancer. In this 33rd video for the Spanish lung cancer video library, Dr. Raez discusses current standards and leading options for first-line treatment of EGFR mutation-positive NSCLC. http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Dec 7, 2016 Spanish Lung Cancer Library: Antonio Calles, MD, Medical Oncologist, Thoracic Oncology Program, Hospital General Universitario, Gregorio Marraron, Madrid, Spain joined GRACE to discuss the basics of Lung Cancer for spanish speaking patients and caregivers. For our 5th video Dr. Calles joined GRACE to discuss the most appropriate treatment for elderly patients with advanced NSCLC, and whether age alters the recommendations. http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Dec 28, 2016 Spanish Lung Cancer Library: Dr. Brian Hunis, Medical Director, Head and Neck Cancer Program, memorial Cancer Institute, Miami, Florida, joined GRACE to discuss the basics of Lung Cancer for spanish speaking patients and caregivers. In this video Dr. Hunis speaks about treating later stage small cell lung cancer.

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GRACE – Global Resource for Advancing Cancer Education Published on Dec 12, 2016 Spanish Lung Cancer Library: Dr. Brian Hunis, Medical Director, Head and Neck Cancer Program, Memorial Cancer Institute, Miami, Florida, joined GRACE to discuss the basics of Lung Cancer for Spanish speaking patients and caregivers, in this video Dr. Hunis reviews the risk factors for lung cancer. http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Dec 15, 2015 Drs. Ben Solomon, Leora Horn, & Jack West discuss whether the data highlighting cognitive deficits from whole brain radiation therapy (WBRT) for patients with brain metastases should change our recommendations for prophylactic cranial irradiation (PCI). http://cancergrace.org/lung/2015/12/1…

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GRACE – Global Resource for Advancing Cancer Education Published on Dec 5, 2018 Drs. H. Jack West, Medical Director – Thoracic Oncology Program at Swedish Cancer Institute, President and CEO of GRACE, Karen Kelly – Associate Director for Clinical Research at UC Davis Comprehensive Cancer Center, and Sandip Patel – Medical Oncologist and Associate Professor of Medicine at Moores Cancer Center, UC San Diego Health, gathered post meeting to discuss new information from ASCO 2018 regarding lung cancer. In this roundtable video, the doctors discuss the use of keytruda in previously treated and now relapsing patients with small cell lung…

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GRACE – Global Resource for Advancing Cancer Education Published on Jan 15, 2016 Terrie Schmith, a stage IV melanoma survivor, describes her battle with the disease and her successful treatment with pembrolizumab. http://cancergrace.org/cancer-treatme…

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GRACE – Global Resource for Advancing Cancer Education Published on Jan 18, 2016 Dr. James Gulley, National Cancer Institute, discusses immunotherapies for genitourinary cancers, including recent trial results. He also addresses early data which may indicate that using immunotherapy sooner may benefit patients. http://cancergrace.org/cancer-treatme…

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 14, 2018 Dr. Sandip Patel, Associate Professor of Medicine at the Moores Cancer Center, UC San Diego Health, joined GRACE to offer updates to our Lung Cancer Video Library. In this video, Dr. Patel discusses the current status of combinations of immunotherapy agents in advanced nsclc. http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Apr 30, 2018 Dr. Vamsidhar Velcheti, Hematology and Medical Oncology with the Cleveland Clinic Main Campus, joined GRACE to discuss updates to our Lung Cancer Video Library. In this video, Dr. Velcheti discusses gilotrif/afatanib in squamous non small cell lung cancer. Please visit our forums at http://cancergrace.org/forum/q-and-a-…, and scroll to the bottom of the page to ask a question! http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Apr 30, 2018 Dr. Vamsidhar Velcheti, Hematology and Medical Oncology with the Cleveland Clinic Main Campus, joined GRACE to discuss updates to our Lung Cancer Video Library. In this video, Dr. Velcheti discusses biomarkers for immunotherapy and if there is anything better than PDL1. Please visit our forums at http://cancergrace.org/forum/q-and-a-…, and scroll to the bottom of the page to ask a question! http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 14, 2018 Dr. Sandip Patel, Associate Professor of Medicine at the Moores Cancer Center, UC San Diego Health, joined GRACE to offer updates to our Lung Cancer Video Library. In this video, Dr. Patel discusses the basics of managing immune mediated side effects. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 15, 2018 Dr. H. Jack West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, President and CEO of GRACE offers updates to our Lung Cancer Video Library. In this video, Dr. West discusses patients with rapid progression through first line treatment, and what they should receive next. .http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 14, 2018 Dr. Karen Kelly, Associate Director for Clinical Research at UC Davis Comprehensive Cancer Center, met with GRACE to bring updates to our Lung Cancer Video Library. In this video, Dr. Kelly discusses the role of immunotherapy in stage lll NSCLC, specifically the Pacific Trial and Imfinzi. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 14, 2018 Dr. Sandip Patel, Associate Professor of Medicine at the Moores Cancer Center, UC San Diego Health, joined GRACE to offer updates to our Lung Cancer Video Library. In this video, Dr. Patel discusses evolving standards for molecular testing in advanced NSCLC. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 17, 2018 Dr. H. Jack West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, President and CEO of GRACE offers updates to our Lung Cancer Video Library. In this video, Dr. West discusses whether immunotherapy works in patients with driver mutations like EGFR and ALK. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 15, 2018 Dr. H. Jack West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, President and CEO of GRACE offers updates to our Lung Cancer Video Library. In this video, Dr. West discusses “consolidation” radiation to residual disease after a good response to first line therapy, who would receive it and why. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 17, 2018 Dr. H. Jack West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, President and CEO of GRACE offers updates to our Lung Cancer Video Library. In this video, Dr. West discusses chemotherapy and immunotherapy combinations in advanced squamous non small cell lung cancer. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Oct 17, 2018 Dr. H. Jack West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute, President and CEO of GRACE offers updates to our Lung Cancer Video Library. In this video, Dr. West discusses chemotherapy and Immunotherapy combinations in advanced non-squamous non small cell lung cancer. For more visit http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Mar 26, 2019 GRACE is excited to bring to you a new series on Cancer Myths in the Latin Community. Our friend and partner, Narjust (N.J.) Duma, MD is a Chief Hematology/Medical Oncology Fellow at Mayo Clinic in Rochester, MN. Dr. Duma is committed to her research and advocacy in diversity and inclusion. She was recognized as the 2018 resident of the year by the National Hispanic Medical Association. N.J. speaks to cancer myths in the Latino community, and in this video N.J. discusses the myth of sugar and cancer.…

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GRACE – Global Resource for Advancing Cancer Education Published on Jun 26, 2018 Kurtis Davies, PhD, with the University of Colorado Health Sciences Center Department of Pharmacology, joined GRACE for our Webinar Series on Molecular Diagnostic Testing and Next Generation sequencing in Lung Cancer. In this video, Dr. Davies discusses resistance to targeted therapies and the importance of retesting. Please visit our forums at http://cancergrace.org/forum/q-and-a-…, and scroll to the bottom of the page to ask a question! http://cancerGRACE.org/

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GRACE – Global Resource for Advancing Cancer Education Published on Mar 26, 2019 GRACE is excited to bring to you a new series on Cancer Myths in the Latin Community. Our friend and partner, Narjust (N.J.) Duma, MD is a Chief Hematology/Medical Oncology Fellow at Mayo Clinic in Rochester, MN. Dr. Duma is committed to her research and advocacy in diversity and inclusion. She was recognized as the 2018 resident of the year by the National Hispanic Medical Association. N.J. speaks to cancer myths in the Latino community, and in this video N.J. introduces herself and the following series. See…

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