OBR Daily Commentary

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FDA Approves Foundation Medicine’s FoundationOne CDx, The First Pan-Tumour Comprehensive Genomic Profiling Assay Incorporating A Broad Range Of Companion Diagnostics

(Roche) Dec 4, 2017 - Roche announced today that the US Food and Drug Administration (FDA) has approved FoundationOne CDx™, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care.

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H. Jack West, MD (Posted: December 04, 2017)

quotesOn balance, I think this is an advance, as I believe that the lack of certainty about coverage is a significant barrier in getting NGS testing. For cancers like lung cancer, where there are already multiple molecular markers that can be tested individually or through NGS with a savings of limited tissue and potentially cost, there is a clear advantage to efficiency of broader testing. It's less clear that NGS is beneficial for a cancer for which there are not several previously identified markers to evaluate for. Though we might have some concern about mass scaling of a test costing several thousand dollars per test when there are no data demonstrating that this improves patient outcomes, I think there is more potential for harm based on poor decisions resulting from testing. Specifically, some clinicians may impart too much optimism on a treatment recommended based only on preclinical data and a theoretical benefit. These NGS reports include a wide range of possibly beneficial treatments, but that long tail, in order to justify the cost of the test, very often includes treatments of unclear if not frankly dubious benefit. There is the potential for net harm from the suggested targeted therapies, especially if oncologists and patients discard treatment options that are not individualized and therefore less sexy, but they still have well-established efficacy across broad populations. And there is definitely reason to be concerned that the costs of care will rise significantly because many oncologists will have too low a threshold to administer everolimus, at a cost of more than $10,000/month for every tenuously recommended mutation that could be associated with benefit. Whether broad molecular testing provides a quantum leap in efficacy of treatment or only its cost will depend on how wisely oncologists use the data that will pour in from this testing.quotes

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CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival

(BMS) Nov 30, 2017 - Bristol-Myers Squibb Company announced today that the Phase 3 study CheckMate -078, evaluating Opdivo (nivolumab) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC), was stopped early because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared with the control arm.

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H. Jack West, MD (Posted: December 01, 2017)

quotesWhile reassuring to see that the results in a Chinese population recapitatulate those seen in global phase 3 trials with other populations, these results only provide results I would have presumed to be the case. Reassuring, but it wasn't a question I would have had without these data. I have many Chinese patients and haven't hesitated to treat them with nivolumab in the second line setting based on the results of CheckMate-017 (for squamous NSCLC) and CheckMate-057 (for non-squamous NSCLC).quotes

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Lung Cancer May Grow Faster During Immunotherapy

(Medscape Medical News) Nov 13, 2017 - A retrospective analysis from France found that 14% of patients with advanced lung cancer showed an acceleration of tumor growth while receiving immunotherapy.

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

quotesThis is interesting and somewhat helpful for turning a clinical observation at the anecdotal level into retrospective data that actually characterize the frequency of this issue in a clinical population. However, we also need to ask what we do with this information. The report indicates that hyper-progression is seen a little more commonly with immunotherapy than with chemo in advanced NSCLC. However, we can't reliably predict who will demonstrate hyper-progression. The authors find that patients with a higher number of metastatic sites have higher risk, but the absolute difference isn't enough to make this a clinically helpful predictor. Given the clear survival benefit with several immune checkpoint inhibitors over chemo in previously treated NSCLC, this information doesn't/shouldn't dissuade an oncologist from favoring a checkpoint inhibitor based on the far more clear prospective clinical trial data. That said, it's a valuable starting point for further study of this issue.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

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

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

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Jennifer Levin Carter, MD, MPH

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

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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...

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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...