OBR Daily Commentary

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A Cancer Conundrum: Too Many Drug Trials, Too Few Patients

(New York Times) Aug 12, 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research.

Thomas Marsland, MD (Posted: August 17, 2017)

quotesSo I actually had the chance to read this article in the Sunday Times while traveling (am usually more of a WSJ guy). I think it raises a number of interesting points. One is the idea of how many drugs in a given category do we really need? Are 20 check point inhibitors really necessary? Yet every company wants to have one of their own. I would respectfully suggest that after the first two or three drugs in a given category, if efficacy is comparable, that cost as part of the value proposition should be considered in the approval process. If it costs less then it should be approved. Clearly one of the issues is that we need to put more patients on trials. In adult community oncology we put as an average only about 5% of patients on trials. We should undertake a national initiative to increase this number significantly. Why not 15% or more??? As the cost of treatments escalates it is even more important that we have the right drug for the right patient at the right time. Only through research and clinical trials will we be able to do that. With that being said we therefore need to make trials more available and easier to use in the community. Trial design looking at alternate marker outcomes for target treatments will result in shorter, less costly trials requiring fewer patients. As I said in one of my other comments, having clinical trials available in my new practice has gone a long way toward making it more fun again. quotes

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Sneak Peek Into the ESMO 2017 Press Program

(ESMO) August 11, 2017 - ESMO 2017 is once again the place to be for breaking news on cancer research. ESMO 2017, the annual oncology congress organised by the European Society for Medical Oncology (ESMO) in partnership with the European Association for Cancer Research (EACR) will take place in Madrid, Spain, from 8 to 12 September at IFEMA, Feria de Madrid.

H. Jack West, MD (Posted: August 14, 2017)

quotesIt appears that while the PACIFIC trial of durvalumab consolidation after chemoradiation is being presented at ESMO, we won't see data from either the MYSTIC trial (durvalumab/tremelimumab or durvalumab monotherapy vs. chemo doublet first line for advanced NSCLC) or FLAURA (first line osimertinib vs. erlotinib or gefitinib for EGFR mutation-positive advanced NSCLC). We knew MYSTIC is negative for a PFS benefit, so we should perhaps not be surprised that AZ isn't eager to highlight the results, but I think if there were anything favorable to mitigate the disappointment, they'd have tried to stanch the bleeding by presenting the data. I suspect there will be little to encourage us when AZ ultimately deigns to show us real data. More notable is the omission of FLAURA from the ESMO program, a trial reported as positive for a significant improvement in the primary endpoint of PFS that could potentially change practice and broaden the indication for osimertinib to include first line treatment if the PFS benefit is substantial enough. Unless AZ just doesn't want to compete for the limelight with the PACIFIC trial that will likely cause a Beatlemania-reminiscent hysteria by both being an immunotherapy and being positive, this suggests that the results aren't as captivating as some would have hoped. As an alternative, the IASLC may have promised the moon and the stars to AZ to postpone presentation of a high-impact trial for the first time at the World Conference on Lung Cancer, but I would have anticipated that AZ should want to get positive results out on a potentially practice-changing therapy to as broad an audience as possible, as quickly as possible. We'll eventually see what the data show, but I'm disappointed that two of three important lung cancer trials from which we've heard initial results from recent press releases apparently won't be presented at ESMO. Makes you wonder why they're dragging their feet.quotes

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Take the Generic, Patients Are Told. Until They Are Not.

(New York Times/ProPublica) Aug 6, 2017 - Consumers have grown used to being told to give up their brand-name drugs in favor of cheaper generics. Now some are finding the opposite is true.

Winston Wong, PharmD (Posted: August 14, 2017)

quotesThe rationale is pretty simple. The branded drugs are now presenting deep rebate discounts, and bring the net cost to somewhere comparable to the generic/biosimilar. If the cheaper drug was dispensed outright, the only win is the patient paying the lower copay and payer experiences an immediate cost savings. If the more expensive brand is dispensed, the PBM/Payer get the rebate, of which the PBM receives a portion of, and hopefully the piece of the rebate that is passed through to the payer will bring the cost down, if they can even track it. So in essence, that final statement is very true. Someone has to be making money from the deal to make it fly.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...

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...

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

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

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...