OBR Daily Commentary

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Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer

(Eli Lilly) Oct 10, 2017 - Eli Lilly and Company today announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS).

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H. Jack West, MD (Posted: October 10, 2017)

quotesThis is an unfortunate result, in a hard setting to treat. About 20% of patients with advanced NSCLC have a KRAS mutation, making it the most common molecular aberration we see, but also one for which we have no effective targeted therapy. Abemaciclib demonstrated promising activity in earlier phase clinical studies, so this was certainly an important study. However, the fact that patients with a KRAS mutation are well recognized as been especially unlikely to benefit much from EGFR TKI therapy like erlotinib have led some critics to charge that the control arm in this study was receiving what we might interpret as little more than a placebo with side effects. Nevertheless, there was no difference in overall survival. Despite the improvements in some secondary endpoints and the charge that the control arm did better than expected (which I believe was due to the requirement that patients have failed docetaxel-based chemo, along with most having received an immune checkpoint inhibitor as well, making this a highly selected population for less aggressively paced disease), these results will likely not be enough to make this a viable treatment approach. Effective treatment for KRAS mutated NSCLC remains a significant unmet need, with insufficient progress marked by this agent and trial.quotes

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TAGRISSO® (osimertinib) Granted Breakthrough Therapy Designation By US FDA For The 1st-Line Treatment Of Patients With EGFR-Mutation Positive Non-Small Cell Lung Cancer

(AstraZeneca) Oct 9, 2017 - Designation based on positive Phase III FLAURA trial results; sixth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine.

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

quotesThe data from FLAURA definitely support a first line approval, and the NCCN has just revised their guidelines in NSCLC to reflect that. The lung cancer community looks forward to a prompt approval of osimertinib in the first line setting. I have several patients in whom I am eager to prescribe osimertinib based on this indication. It can't happen soon enough.quotes

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DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients with Cancer

(UC San Diego Health) Oct 1, 2017 - In a first-of-its-kind study, University of California San Diego School of Medicine researchers report that a blood sample, or liquid biopsy, can reveal which patients will respond to checkpoint inhibitor-based immunotherapies.

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H. Jack West, MD (Posted: October 02, 2017)

quotesSadly the headline, "DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients with Cancer" leaves out the phrase "with no better accuracy than standard PD-L1 testing". To be clear, if positive, patients have a 45% response, and if negative, it's 15%. Perhaps a better headline would be "New test NOT helpful, with results neither necessary nor sufficient to predict which patients will benefit from immunotherapy".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...

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...