OBR Daily Commentary

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OSE Immunotherapeutics Announces That the Independent Data Monitoring Committee Recommends Continuation of Pivotal Phase 3 Clinical Trial of Tedopi® In Non-Small Cell Lung Cancer

(OSE Immunotherapeutics) Jan 24, 2017 - OSE Immunotherapeutics SA announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s international pivotal Phase 3 clinical study (Atalante 1) of Tedopi® for the treatment of non-small cell lung cancer (NSCLC) has unanimously recommended continuation of the trial, without asking for modifications.

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H. Jack West, MD (Posted: January 25, 2017)

quotesMy annual family newsletter has higher standards for newsworthiness than a press release saying a trial is ongoing.quotes

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The New Era of First-Line Immunotherapy for Advanced NSCLC

(Medscape Medical News) Jan 23, 2017 - As valuable as it has been to get new approvals for patients with previously treated advanced non–small cell lung cancer (NSCLC), as described recently, the stakes are even higher when a new therapy is approved in the first-line setting.

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H. Jack West, MD (Posted: January 23, 2017)

quotesA brilliantly insightful, balanced commentary. Full disclosure: I wrote it.quotes

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Merck Receives FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

(Merck) Jan 10, 2017 - Submission based on data from KEYNOTE-021 trial, Cohort G, which enrolled patients regardless of PD-L1 expression.

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H. Jack West, MD (Posted: January 11, 2017)

quotesI'm not a fan of this approach based on the limited data we have. First, this fining is predicated on a trial with only 123 patients. Though PFS was better with combined chemo and pembrolizumab, there was no difference in overall survival, despite the fact that only 32% of patients assigned to first line chemo had crossed over to get pembrolizumab in the published report (Langer, Lancet Oncol 2016). Moreover, toxicity was clearly greater in the recipients of chemo/pembrolizumab combination. Finally, the concept of maintenance pembrolizumab/pemetrexed indefinitely, with it quite likely that only one of these extremely pricey agents is driving the ongoing benefit but no way to determine which, means that the cost of this treatment is extremely high and buys many patients only the added cumulative toxicity of further treatment with at least one agent that they are not benefiting from significantly. This is clearly a shrewd marketing move for Merck, trying to broaden their first line claim from 28-30% of the patients, a subset that is particularly likely to benefit from immunotherapy, to the vast majority of NSCLC patients. But it is an assault on the concept of precision medicine that prioritizes corporate interests and squeezes out other companies and agents that have a competing claim in second line. The key issues are a short term response rate and PFS benefit with far greater net costs, significantly greater toxicity, and no evidence of improved survival, especially if all of the patients assigned to first line chemo were to actually get the checkpoint inhibitor therapy that they should in the second line setting. It is a campaign of marketing interests over refinement of treatment that is truly best for the patient.quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Professor and Chair, Department of Radiation Oncology...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Health Policy
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Joseph Bailes, MD

National Health Policy Expert...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Professor and Physician-in-Chief of the Ohios State Uni...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...