OBR Daily Commentary

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Big Pharma Faces Costly Setback In Cancer Fight

(Financial Times) Feb 9, 2017 - Investors lose billions as immunotherapies fall short of high expectations.

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H. Jack West, MD (Posted: February 09, 2017)

quotesWhat is most remarkable is how many successes we've had with immunotherapies across a wide range of cancers over the past few years. That investors are losing money due to results falling short of expectations is far more a product of the irrationally exuberant, even delusional expectations of many in the financial sector than on the failure in an absolute sense of immunotherapies relative to what should have been realistic expectations for a medical intervention.quotes

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This $94,000-a-Year Cancer Drug Caused Rashes and Rarely Worked. Now Trump Could Make FDA Approvals Even Easier

(Los Angeles Times) Feb 3, 2017 - In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer.

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H. Jack West, MD (Posted: February 06, 2017)

quotesIt is disingenuous for the media to paint erlotinib (Tarceva) as a completely ineffective and inappropriately marketed drug when what actually happened was that the FDA approval was based on a significant overall survival benefit for erlotinib over supportive care in an unselected population (conducted before we even knew of EGFR mutations), followed by many subset analyses that demonstrated modest but consistent efficacy even in patients with squamous NSCLC (who almost never have EGFR mutations) and those with EGFR wild type. Was it remarkably effective? Not at all. Were oncologists enthusiastic about it? No. But it wasn't until a much later study indicated no significant benefit that one would definitely say that the preponderance of evidence shifted away from treatment of EGFR wild type patients with erlotinib. In addition, the EGFR mutation test is not perfect. I have had several patients who tested negative for an EGFR mutation on initial workup who later received 2nd or 3rd line erlotinib and enjoyed a spectacular, long-lasting response. In a few cases, later testing showed an EGFR mutation previously missed. Those patients would have almost certainly died years earlier without the benefit of the opportunity to receive erlotinib. Whether one was actually a proponent of EGFR TKI therapy in EGFR mutation-negative patients or not, it is revisionist history to act as if our current perspective should have been held based on the less extensive evidence available in the past. Moreover, oncologists, patients, and the mass media still regularly sensationalize treatments without a scintilla of evidence outside of a rare case of a patient doing well. It is the height of hypocrisy for these same oncologists, patients, and mass media to now act indignant that the level of evidence was insufficient to justify using erlotinib, while everyone clamors for off-protocol use of immunotherapy or other new therapies beyond current indications based on wild-eyed optimism and far, far less evidence.quotes

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Roche Cancer Drug Taking Bite Out Of Bristol's Opdivo

(Reuters) Jan 27, 2017 - Roche's cancer drug Tecentriq hit the market months behind immuno-oncology (I/O) medicines from Merck and Bristol-Myers Squibb Co but the Swiss drugmaker's treatment is making up lost ground.

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H. Jack West, MD (Posted: January 27, 2017)

quotesIt's not surprising that the second line NSCLC market has shifted away from nivolumab to atezolizumab and pembrolizumab from nivolumab enjoying the overwhelming majority of that market share a year ago. The recent presentation of newer data and subsequent FDA approvals have meant that atezolizumab is now a second line option given on a more convenient every 3 week schedule vs. nivolumab's every 2 week schedule, while both have no requirement for any PD-L1 testing or a threshold level of expression. Even though pembrolizumab requires at least 1% staining for second line use based on the revision of that indication, the new approval of pembrolizumab as first line therapy for high PD-L1 expressors means that the vast majority of NSCLC are now being routinely tested for PD-L1 expression in their initial workup as a standard of care, whereas PD-L1 testing was not previously a necessary step. This means that pembrolizumab, as another every 3 week option, compares favorably as an alternative to atezolizumab for any patients with > or =1% PD-L1 expression. Finally, though the negative results from Checkmate-026, comparing nivolumab to standard chemotherapy in first line NSCLC, do not speak to the second line setting, it is likely that this has led to somewhat lower enthusiasm toward nivolumab when comparable checkpoint inhibitor options have a more attractive treatment schedule and have not been tainted by negative first line results, at least not yet.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...