Author: Editor

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…

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…

Lowell Anthony MD Of Markey Cancer Center Discusses When Do You Prescribe Bland Vs Chemo Or Radio Embolization: Chemo Embolization Has Not Caught On In Our Institution Because The Side Effects & Extra Months Of Durability Are Not Of Value.

Lowell Anthony MD Of Markey Cancer Center Discusses Inducing Embolization Syndrome When Performing infarction: Not Uncommon To Take 4-8 Weeks To Get Over The Treatment Of Embolotherapy.

Lowell Anthony MD Of Markey Cancer Center Discusses Evaluating mTOR Inhibitor Everolimus With Embolotherapy: Objective Response Rate Of 57 We Did Not Stop Everolimus During Embolotherapy, We Continued It.

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:…

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,…

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…

Max S. Topp MD Of University Hospital of Wuerzburg Discusses Using Steroids To Mitigate Cytokine-Release Syndrome: Did Not See Any Grade 3, 4, Or 5 Cytokine-Release Syndrome When Adding Steroids.

Max S. Topp MD Of University Hospital of Wuerzburg Discusses Mitigate Cytokine-Release Syndrome With Steroids In Practice: If Only 10Of Patients End Up In The ICU Compared To 30That Is Significant In Practice.

Joan Brugge PhD Of Harvard Medical School Discusses The Process Of Tumor Genesis & Tumor Cells Response To Therapy: Its Predicted That If You Could Target Stress Relief Programs You Might Get Much More Efficient Therapy.

Giorgio Scagliotti MD @giorgioscaglio3 Of University of Torino Discusses Updates In The Thoracic Oncology Field: We Now Have Specific Inhibitors That Are Producing Durable Responses & Interesting Activity In Terms Of PFS & OS.

Ziad Bakouny MD @ZiadBakouny Of Dana-Farber Cancer Institute Discusses Updates On Sarcomatoid & Rhabdoid Renal Cell Carcinoma: Immune Checkpoint Inhibitors Are Doing Really Well In Sarcomatoid RCC.

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…

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…

Tal Zaks MD, PhD, Chief Medical Officer at Moderna Therapeutics Discusses Questions About mRNA: Takes 50-60 Days From Biopsy To Treating Patient, Good Scientific Rational For Expected Synergy With A Checkpoint Inhibitor.

Tal Zaks MD, PhD, Chief Medical Officer at Moderna Therapeutics Discusses How Did The Patients Do: Out Of 13 Patients Treated In The Adjuvant Setting 2 Progressed & 11 Remains Disease Free.

Tal Zaks MD, PhD, Chief Medical Officer at Moderna Therapeutics Discusses Emerging Data For Personalized Vaccine Approach: Safety Profile Was Clean & No Dose Limiting Toxicities, Reached 1mg Dose, Moving Into A Phase 2 Study.

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,…

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,…

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…

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.…

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.…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

Rafael Santana-Davila MD @valdesan Of Fred Hutchinson Cancer Research Center Discusses Lurbinecedin Data At ASCO Important & Encouraging/ Want To See It Replace Topotecan Based On Safety Profile & Move Into First Line & In Combos.

Jens Hillengass MD @JHillengass Of Roswell Park Comprehensive Cancer Center Discusses Updates In Myeloma: Bispecific Antibodies & New Treatment Coming For Multiple Myeloma That Was Used In POEMS Syndrome.

Jens Hillengass MD @JHillengass Of Roswell Park Comprehensive Cancer Center Discusses B-Cell Maturation Antigen (BCMA): Many Trials Using This Marker As A Target, Bispecific Antibodies Target This Marker.

Josh Brody MD @joshuabrodyMD Of Icahn School of Medicine at Mount Sinai Discusses Shout-Out: Very Grateful For Everything…Maybe Not All The Cooking.

Josh Brody MD @joshuabrodyMD Of Icahn School of Medicine at Mount Sinai Discusses Results Of Novel In Situ Vaccine: Vaccine Is Created Directly At The Tumor Site, Minor Side Effects Like Fever Or Flu Like Symptoms.

Josh Brody MD @joshuabrodyMD Of Icahn School of Medicine at Mount Sinai Discusses New PI3K-Delta Inhibitor Umbralisib: Greater Then 50% Response Rate, Remissions Lasting For Over A Year.

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…

Robert Rifkin MD Of US Oncology Research Discusses Measuring BCMA: Do Not Have To Wait For Relapse, We Know When The Disease Has Become Resistant.

Robert Rifkin MD Of US Oncology Research Discusses Trial Updates At ASCO: Approval Of Daratumumab In Combination With Revlimid Or Velcade & Dexamethasone.

Robert Rifkin MD Of US Oncology Research Discusses Isatuximab & Daratumumab: When You Add Isatuximab To Pomalidomide & Dexamethasone Outcomes Are A Lot Better.

Robert Rifkin MD Of US Oncology Research Discusses Connect MM Myeloma Disease Registry: This Is A Special Group Of Myeloma Patients Because They Respond To Venetoclax.

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…

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…

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…

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…

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…