OBR Daily Commentary

forumImage

Imfinzi Granted Breakthrough Therapy Designation By US FDA For Patients With Locally-Advanced Unresectable Non-Small Cell Lung Cancer

(AstraZeneca) July 31, 2017 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

Read Article arrow

H. Jack West, MD (Posted: July 31, 2017)

quotesWe have learned from a press release that the PACIFIC trial is positive for a significant improvement in PFS after chemo/radiation for patients with locally advanced, unresectable NSCLC. Because this treatment entails an extra year of IV treatment every two weeks and a cost likely in the range of $180-200K per patient, most experts feel that the PFS benefit should be remarkably long and/or be accompanied by a significant improvement in survival. In this setting, demonstrating a 3-4 month delay in relapse without a survival benefit won't offset the cost in terms of time on treatment for patients or cost to society. The entire lung cancer community looks forward to the presentation of the actual trial data at an upcoming meeting -- I hope at ESMO 2017 (where I will be happy to provide commentary on the detailed findings). If the PACIFIC trial achieves these criteria, it should rightfully become adopted as a new standard of care in this setting. It would be ideal, however, if we can determine which patients are most or least likely to benefit from this extended treatment so that we can concentrate these extra efforts and costs on the patients who will truly benefit from them.quotes

Add Comment 1 Comment
forumImage

Pemetrexed in Nonsquamous Non–Small-Cell Lung Cancer The Billion Dollar Subgroup Analysis

(JAMA Oncology) July 27, 2017 - Pemetrexed, a next-in-class antifolate drug, was first approved by the US Food and Drug Administration (FDA) in 2004 in combination with cisplatin for the treatment of pleural mesothelioma.

Read Article arrow

H. Jack West, MD (Posted: July 28, 2017)

quotesIt's important to note that while the statistics may well be over-interpreted/misinterpreted to imply that pemetrexed demonstrates meaningfully superior efficacy vs. other partner agents for a platinum in advanced non-squamous NSCLC, I and most of my colleagues who have a particular focus and expertise in thoracic oncologists try to be very judicious in our interpretation of the landscape. Few if any of us would consider pemetrexed to be the clear best choice among the various options, and I don't think any expert would consider alternatives to be a wrong choice. That said, there is near uniformity in favoring carbo/pemetrexed +/- bevacizumab in advanced non-squamous NSCLC not because it's overwhelmingly better but because it's just better enough in its therapeutic index to bubble up to the top. We need to choose one regimen, and for nearly all thoracic oncologists who have a full range of options available, the combination of good if not markedly superior efficacy combined with the favorable side effect profile, convenient schedule, and several other factors make it the best option to nearly all of us, even if not by a wide margin. That it is expensive, and specifically more expensive than some very inexpensive and perfectly serviceable alternatives is a separate question. The reality of the situation is that few specialists in thoracic oncology are forced to weigh or even carefully consider the question of the incremental value of pemetrexed over other alternatives. Unless that issue becomes prioritized enough for US oncologists to be incentivized to carefully consider the relative costs of agents, we will focus far more on the patient experience and patient/physician satisfaction without feeling compelled to seek a relative bargain option.quotes

Add Comment 1 Comment
forumImage

Tagrisso Significantly Improves Progression-free Survival In The Phase III FLAURA Trial For Lung Cancer

(AstraZeneca) July 27, 2017 - AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

Read Article arrow

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

quotesThis is an important trial and a potential totally practice-changing result, but its true significance will ultimately depend on whether the PFS difference is not just statistically significantly better but whether the PFS with first line osimertinib is at least 6-7 months, and ideally more like 9-10 months better than gefitinib or erlotinib. Because first line osimertinib means losing a line of therapy for about 50-60% of patients who would test positive for T790M after first line gefitinib or erlotinib and still receive osimertinib second line (with an expected PFS of about 9 months), a PFS benefit of 5.5 months could be statistically significant for PFS benefit but not truly better than sequential therapies. We will anxiously await the data from the trial, presumably to be presented at ESMO in September. I think the difference could turn out to be more than enough (thinking of the results of the ALEX trial in ALK positive NSCLC as an example), or it may turn out to be statistically superior at an endpoint that still isn't enough. I'll be looking for at least 7 months of PFS benefit (I'd discount from the 9-10 month PFS expected from second line osimertinib because here 100% of patients will receive the benefit, rather than just 50-60%), or an improvement in overall survival when we see the actual data.quotes

Add Comment 1 Comment

Meet the Editorial Board

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
member photo
H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

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

Community Oncology
member photo
Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
member photo
Jennifer Levin Carter, MD, MPH

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

Financial Sector
member photo
Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
member photo
Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
member photo
William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...

Payer
member photo
Winston Wong, PharmD

President, W-Squared Group...