OBR Daily Commentary

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FDA Expands Approval Of Imfinzi To Reduce The Risk Of Non-small Cell Lung Cancer Progressing

(FDA.gov) Feb 16, 2018 - The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

H. Jack West, MD (Posted: February 20, 2018)

quotesThough we haven't yet seen a significant overall survival benefit with maintenance durvalumab after chemo/radiation, I believe the very significant and sustained PFS benefit are extremely likely to be associated with an OS benefit at least at 2 and 3 years out, but may or may not lead to more patients cured. If we see no patients cured and patients can do just as well being "rescued" with immunotherapy upon relapse, and we can spare some patients already cured by chemo/radiation to receive prolonged immunotherapy, there won't be a clear benefit to giving everyone immunotherapy automatically. We will need to see the long-term results of the trial and whether long term OS is better from a year of durvalumab. In the meantime, we are left considering whether to change our standard based on PFS alone. I think the potential harm to thousands of patients in the next few years, by withholding a therapy that has a significant chance of improving survival, is greater than any harm that could theoretically come from giving durvalumab based on a tremendous PFS benefit, even if it doesn't improve long-term cure rate. Durvalumab will be my standard of care in this setting while we wait for more mature data from the PACIFIC trial. Please see my video for further thoughts: http://traffic.libsyn.com/force-cdn/ec/beacon/BMIC-024_Durvalumab_Stage_III_NSCLC_Standard.mp4quotes

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Drug Copies Ready To Take Next Bite Out Of Roche's Cancer Sales

(Reuters) Feb 13, 2018 - European oncologists will soon get their hands on cut-price copies of breast cancer drug Herceptin, turning the screws on maker Roche and giving another boost to a new breed of companies focused on so-called biosimilars.

Winston Wong, PharmD (Posted: February 19, 2018)

quotesOnce the biosimilars are out on the market here in the US, it will be the first test of how confident the oncology community will be with the use of biosimilars. From a payer perspective, they are not interchangeable, and the Oncologists will have some clout to help drive the market, especially of the financial incentive is not large enough to motivate the switch to the biosimilar.quotes

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Merck KGaA, Pfizer's Immunotherapy Fails In Lung Cancer Trial

(Reuters) Feb 15, 2018 - Merck KGaA and Pfizer’s cancer drug Bavencio could not be shown to improve survival in lung cancer patients that had previously undergone unsuccessful chemotherapy, Merck said.

H. Jack West, MD (Posted: February 15, 2018)

quotesOn its face, the report that a trial of avelumab vs. docetaxel in chemotherapy-pretreated NSCLC seems surprising unless it's a clearly inferior checkpoint inhibitor to the ones that have already demonstrated positive results and similar efficacy in very similar trials -- namely nivolumab, pembrolizumab, and atezolizumab. We have presumed that these agents are all far more similar than different. The JAVELIN Lung 200 trial did note that the cross-over of such a higher proportion of patients to subsequent immunotherapy in this trial (26.4% on docetaxel arm, vs. 5.7% on avelumab arm) vs. other ones that have been positive is likely to be a relevant factor that compromised the ability to detect an improvement in OS in the broad study population. Frankly, I think it's disappointing that only just over 25% of patients received access to clearly very effective immunotherapy that has been a standard of care now for a few years. In my clinic, nearly 100% of patients who were ever eligible for a checkpoint inhibitor receive it over the course of their illness. The only question is whether it is delivered first line, second line, or later. And while this trial was conducted in a different time and place, the evidence should lead us to conclude that only 26% of patients receiving immunotherapy is gross under-treatment. It is also notable that the effects were reportedly greater in those patients with high level PD-L1 expression, as we've generally seen, with a positive survival benefit in that subset. We will need to see the actual data in an upcoming meeting, but I believe that it is premature to conclude that avelumab is a less effective therapy than the similar checkpoint inhibitors that have been approved in this setting already. I think the results may be most instructive in demonstrating that the timing of immunotherapy is not critical for many/most patients to achieve the same overall survival. In the contemporary practice of treating lung cancer, we should expect and aspire to have nearly all eligible patients receive one of these agents at some point over the course of their disease. 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

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

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...