Author: Editor

Saad Usmani, MD, Chief, Plasma Cell Disorders Program, Hematologic Malignancies, Levine Cancer Institute/Atrium Health, UNC Chapel Hill School of Medicine provides outcomes from the MAIA study that compares daratumumab + lenalidomide + dexamethasone versus lenalidomide + dexamethasone in multiple myeloma elderly patients.

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Sara Tolaney, MD, Associate Director, Susan F. Smith Center for Womens Cancers, Director Clinical Trials, Breast Oncology, Associate Professor of Medicine, Harvard Medical School provides an overview of the SOPHIA trial, a phase III of chemotherapy plus margetuximab or trastuzumab in HER+ metastatic breast cancer after pertuzumab with 1-3 prior lines of treatment.

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Sara Tolaney, MD, Associate Director, Susan F. Smith Center for Womens Cancers, Director Clinical Trials, Breast Oncology, Associate Professor of Medicine, Harvard Medical School shares the results of ImPassion130 study, a phase III adding atezolizumab to the 1st line chemotherapy with nab-paclitaxel in patients with PD-L1 positive metastatic triple-negative cancer (TNBC).

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Sara Tolaney, MD, Associate Director, Susan F. Smith Center for Womens Cancers, Director Clinical Trials, Breast Oncology, Associate Professor of Medicine, Harvard Medical School discusses the outcomes from the MONALEESA-7 trial in premenopausal metastatic breast cancer.         premenopausal metastatic breast cancer, monaleesa-7 trial, outcomes

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Leonard Saltz, MD, Executive Director for Clinical Value and Sustainability, Colorectal Oncology Section, Memorial Sloan Kettering Cancer Center discusses the value of liquid biopsy and where it is ready for routine practice in CRC.

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Leonard Saltz, MD, Executive Director for Clinical Value and Sustainability, Colorectal Oncology Section, Memorial Sloan Kettering Cancer Center shares the results from the APACT study, a phase III trial involving adjuvant nab-paclitaxel plus gemcitabine versus gemcitabine alone for surgically resected pancreatic adenocarcinoma.

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Leonard Saltz, MD, Executive Director for Clinical Value and Sustainability, Colorectal Oncology Section, Memorial Sloan Kettering Cancer Center addresses whether current data will change the way we treat colorectal cancer.

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Ravi Salgia, MD, Professor and Chair, Department of Medical Oncology and Therapeutics Research, Associate Director for Clinical Sciences, Arthur and Rosalie Kaplan Endowed Chair in Medical Oncology, City of Hope, opens up about the top challenges in managing non-small cell lung cancer (NSCLC) in patients.

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Ravi Salgia, MD, Professor and Chair, Department of Medical Oncology and Therapeutics Research, Associate Director for Clinical Sciences, Arthur and Rosalie Kaplan Endowed Chair in Medical Oncology, City of Hope, identifies strategies for recognizing PD-L1 status.

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Naiyer Rizvi, MD Price Family Professor of Medicine and Director of Thoracic Oncology, Co-Director of Cancer Immunotherapy, Columbia Irving Medical Center explains the role of PD-L1 and TMB biomarkers in treating lung cancer with both single agent immuno-oncology (I-O) and I-O combinations.

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Naiyer Rizvi, MD, Price Family Professor of Medicine and Director of Thoracic Oncology, Co-Director of Cancer Immunotherapy, Columbia Irving Medical Center explains the results from KEYNOTE-001 which evaluated pembrolizumab in advanced non-small cell lung cancer (NSCLC).

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Danny Rischin, MD, Division of Cancer Medicine, Department of Medical Oncology, Peter MacCallum Cancer Centre, Professor of Medicine, University of Melbourne discusses the updated data for the treatment of cutaneous squamous cell carcinoma (cSCC).

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Danny Rischin, MD, Division of Cancer Medicine, Department of Medical Oncology, Peter MacCallum Cancer Centre, Professor of Medicine, University of Melbourne provides insight on KEYNOTE-048 investigating pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma.

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Robert Rifkin, MD, McKesson Biosimilars, Associate Chair, Rocky Mountain Cancer Centers explains the different combinations that are available and still in develop for the convenience of multiple myeloma (MM) patients.

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Robert Rifkin, MD, McKesson Biosimilars, Associate Chair, Rocky Mountain Cancer Centers explains the significance of the prolonged progression-free survival in patients with relapsed/refractory multiple myeloma (MM) if treating with isatuximab.

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Paul Richardson, MD, Clinical Program Leader, Director of Clinical Research, Jerome Lipper Multiple Myeloma, Institute Physician, Harvard Medical School describes the updated FORTE trial data in multiple myeloma (MM).

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Paul Richardson, MD, Clinical Program Leader, Director of Clinical Research, Jerome Lipper Multiple Myeloma, Institute Physician, Harvard Medical School provides results from the ECOG trial in smoldering multiple myeloma (MM).

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Debra Patt, MD, Executive Vice President, Strategic Initiatives, Academic Programs, Texas Oncology shares the results of the ImPassion130, a phase III study that adds atezolizumab to 1st line chemotherapy with nab-paclitaxel in patients with PD-L1 positive metastatic triple negative breast cancer (TNBC).

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Debra Patt, MD, Executive Vice President, Strategic Initiatives, Academic Programs, Texas Oncology discusses the outcomes from the MONALEESA-7 trial in premenopausal, metastatic breast cancer.

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William Oh, MD, Chief of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai explains the results of KEYNOTe-365, pembrolizumab in metastatic castration-resistant prostate cancer (mCRPC).

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Bradley McGregor MD, Instructor, Medicine, Harvard Medical School, Clinical Director, Lank Center for Genitourinary Oncology, GU Network Liaison, Dana Farber Cancer Institute discusses strategies for treating 2nd line renal cell carcinoma (RCC) patients following I-O in the 1st line.

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Bradley McGregor MD, Instructor, Medicine, Harvard Medical School, Clinical Director, Lank Center for Genitourinary Oncology, GU Network Liaison, Dana Farber Cancer Institute considers a new approach to treating newly diagnosed renal cell carcinoma (RCC) patients.

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Bradley McGregor MD, Instructor, Medicine, Harvard Medical School, Clinical Director, Lank Center for Genitourinary Oncology, GU Network Liaison, Dana Farber Cancer Institute explains the data on enfortumab in post-platinum and immuno-oncology (I-O) bladder cancer in patients is impressive enough to possibly change future practice habits.

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Daneng Li, MD, Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, Liver Program Disease Team Lead, City of Hope explains the design of the COSMIC-312 study in hepatocellular carcinoma (HCC) and speculates the potential this trial has.

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Daneng Li, MD, Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, Liver Program Disease Team Lead, City of Hope, gives his take on the role of immuno-oncology (I-O) in managing hepatocellular carcinoma (HCC) considering the recent data.

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Daneng Li, MD, Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, Liver Program Disease Team Lead, City of Hope, explains the outcomes from KEYNOTe 240 trial comparing pembrolizumab versus placebo in 1st line hepatocellular carcinoma (HCC) patients.

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New York, NY, June 28, 2019 – Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEVâ„¢ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),[i] for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.[ii]   “Biosimilars like ZIRABEV can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, Global President, Pfizer…

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Lori A. Leslie, MD, Hematologist-Oncologist, Lymphoma Department, John Theurer Cancer Center, Hackensack Meridian Health shares details on the CLL14 trial in chronic lymphocytic leukemia (CLL) that was presented at ASCO 2019.

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Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope considers whether KRD will replace stem cell transplant as presented at ASCO 2019.

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Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope discusses the future of isatuximab as an option in relapsed/refractory multiple myeloma.

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Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope provides outcomes from the CASSIOPEIA trial that involves daratumumab + VTD in multiple myeloma.

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Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope explains about the ECOG trial outcomes in smoldering multiple myeloma (SMM).

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Pasi A Jänne, MD, Director, Lowe Center for Thoracic Oncology, Belfer Center for Applied Cancer Science, Senior Physician, Professor of Medicine at Harvard Medical School discusses an overview of some of the top challenges in managing non-small cell lung cancer (NSCLC).

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Pasi A Jänne, MD, Director, Lowe Center for Thoracic Oncology, Belfer Center for Applied Cancer Science, Senior Physician, Professor of Medicine at Harvard Medical School decides on whether the results of the RELAY trial will impact the management of 1st line EGFR non-small cell lung cancer (NSCLC).

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Pasi A Jänne, MD, Director, Lowe Center for Thoracic Oncology, Belfer Center for Applied Cancer Science, Senior Physician, Professor of Medicine at Harvard Medical School explains the standard approach to treating non-squamous non-small cell lung cancer patients with high levels of PD-L1.

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Dr. Kristin Higgins, MD, Associate Professor, Department of Radiation ONcology, Winship Cancer Institute of Emory University Medical Director, The Emory Clinic shares how radiation fits into treatment algorithms in stage 3 unresectable NSCLC considering the results of the PACIFIC study.

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Dr. Kristin Higgins, MD, Associate Professor, Department of Radiation ONcology, Winship Cancer Institute of Emory University Medical Director, The Emory Clinic provides her interpretation of the data presented at ASCO 2019 from the PACIFIC Study investigating durvalumab in stage 3 unresectable non-small cell lung cancer (NSCLC).

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Andre Goy, MD, Chairman and Director of the John Theurer Cancer Center (JTCC) at Hackensack University Medical Center and Chief of the Division of Lymphomas discusses how the approval of lenalidomide will impact how follicular lymphoma (FL) and marginal zone lymphoma (MZL) is managed.

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Andre Goy, MD, Chairman and Director of the John Theurer Cancer Center (JTCC) at Hackensack University Medical Center and Chief of the Division of Lymphomas explains the promising role of CAR-T cell therapies in lymphoma patients.

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Richard S. Finn, MD, Assistant Professor of Medicine, Division of Hematology/Oncology, Geffen School of Medicine, University of California explains the next phase of hepatocellular carcinoma (HCC) management and the research that is included.

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Richard S. Finn MD, Assistant Professor of Medicine, Division of Hematology/Oncology, Geffen School of Medicine, University of California offers his opinion on the role of immuno-oncology (I-O) in the management of hepatocellular carcinoma (HCC).

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Richard S. Finn, MD, Assistant Professor of Medicine, Division of Hematology/Oncology, Geffen School of Medicine, University of California explains the outcomes of hepatocellular carcinoma (HCC) in KEYNOTE-240 which compares pembrolizumab versus placebo in 1st line HCC.

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Philadelphia, PA (June 4, 2019) – Oncoceutics, Inc. announced a publication in the Journal for ImmunoTherapy of Cancerdemonstrating ONC201 immunostimulatory activity in advanced cancer patients when given the recommended phase II dose (RP2D) of 625 mg orally every one week.  The publication, which describes a Phase I trial conducted by Mark Stein, MD, at the Rutgers Cancer Institute of New Jersey (CINJ) to evaluate weekly oral administration of the company’s lead compound ONC201, also confirmed previous studies, which demonstrated that the drug was well-tolerated. Weekly dosing stimulated intratumoral infiltration and activation of natural killer (NK) cells. The immune stimulatory effects that…

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Neelima Denduluri MD, Associate Professor, US Oncology Research, Virginia Cancer Specialists shares the results of the phase III EMBARCA trial that compares the efficacy and safety of talazoparib (TALA) to PCT (capecitabine, eribulin, gemcitabine, vinorelbine) in HER2-metastatic breast cancer patients.

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Debu Tripathy, MD, Professor and Chair, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center shares the results of ImPassion130, a phase III study adding atezolizumab to the 1st line chemotherapy with nab-paclitaxel in patients with PD-L1 positive metastatic triple-negative breast cancer (TNBC).

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Nancy A. Dawson MD, Professor of Medicine at Lombardi Cancer Center elaborates on the preferred agents on the 2nd line setting of renal cell carcinoma if a patient progresses on pembrolizumab/axitinib or ipilimumab/nivolumab.

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Immunotherapies are amazing drugs against cancer. However, they still fail for too many patients. This video series presents IMPRES and TIDE, two of the best predictors of cancer immunotherapy outcomes. It also shows an easy way to combine them and improve their predictions. Finally, it makes suggestions of practical ways to contribute to research on this topic. You can support this work by making a donation: https://donorbox.org/better-predict-cancer-immunotherapy-results You can also ask for collaboration: https://mostaphabenhenda.typeform.com/to/fPEidr Text transcription: https://medium.com/the-ai-lab/how-to-better-predict-cancer-immunotherapy-results-f81747af75c8

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Nancy A. Dawson MD, Professor of Medicine at Lombardi Cancer Center shares the TITAN Study outcomes, investigating apalutamide in metastatic castration-sensitive prostate cancer (mCSPC).

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Nancy A Dawson MD, Professor of Medicine at Lombardi Cancer Center discusses her view on the ENZAMET Study while comparing testosterone suppression versus testosterone suppression + enzalutamide in metastatic hormone-sensitive prostate cancer presented at ASCO 2019.

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Michael B. Atkins MD at Georgetown Lombardi Comprehensive Cancer Center, Scholl Professor and Vice Chair Department of Oncology discusses how to select between different combinations of immuno-oncology and TKIs that are available and for the treatment of 1st line renal cell carcinoma (RCC).

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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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