OBR Daily Commentary

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Imfinzi Granted FDA Priority Review For The Treatment Of Patients With Extensive-Stage Small Cell Lung Cancer

(AstraZeneca) Nov 29, 2019 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.1 A Prescription Drug User Fee Act date is set for the first quarter of 2020.

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H. Jack West, MD (Posted: December 02, 2019)

quotesThis will provide a second option in the same setting for which we already have atezolizumab, first line extensive stage small cell lung cancer, and which produces the same results. This will not move the field forward.quotes

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Takeda Says Cancer Drug Alunbrig Shows Longer Benefit Vs. Crizotinib

(Reuters) Nov 22, 2019 - Japan’s biggest drugmaker, Takeda Pharmaceutical Co Ltd, said long-term data show better outcomes for its Alunbrig drug in certain lung cancer patients compared to an existing treatment. Oncology is a pillar for Takeda as it refocuses on core businesses following last year’s $59 billion takeover of Britain’s Shire. The announcement followed a week of investor conferences at home and in the United States intended to show that its drug pipeline is robust enough to fuel continued growth.

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H. Jack West, MD (Posted: November 25, 2019)

quotesBrigatinib is superior in efficacy compared to crizotinib, but the real comparison is currently alectinib, which is the standard of care today, after it demonstrated tremendous superiority compared to crizotinib in the ALEX trial. Despite the encouraging PFS results of brigatinib in 2nd line trials after patients with ALK-positive NSCLC had progression demonstrated on critozinib, the ALTA-1 trial results looked no better with brigatinib than first line results with alectinib in a very similar population. Numerically, the PFS numbers were slightly worse -- not enough to say that it was a meaningfully worse choice than alectinib, but nothing at all to favor brigatinib over alectinib in this space. Yes, fewer pills daily with brigatinib vs. alectinib, but if that's your leading feature, you're in trouble.quotes

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AstraZeneca Joins Bristol-Myers' Run At Merck in Lung Cancer

(BioPharma Dive) Oct 28, 2019 - AstraZeneca said a combination of Imfinzi and chemotherapy kept lung cancer from getting worse in newly diagnosed patients better than chemotherapy alone. A triple combination of Imfinzi, chemo, and a second immuno-oncology agent called tremelimumab also performed better than chemo alone. Investors are closely watching the results from this trial, called POSEIDON, as it could make AstraZeneca competitive with Merck & Co. in the first-line lung cancer setting. A similar trial of Bristol-Myers Squibb's Opdivo also had positive results last week.

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H. Jack West, MD (Posted: October 29, 2019)

quotesThis development is very likely to prove to be too little, too late for altering first line treatment patterns in advanced NSCLC. The combination of nivolumab/ipilimumab in CheckMate-227 has just been reported to improve not only PFS but OS (Hellman, NEJM), so another anti-PD-L1/CTLA-4 combination that has had a checkered past, with many failures, and thus far has only demonstrated a PFS benefit is not compelling in a setting in which we already have more excellent treatments than we can pursue. As I've previously said, "You don't bring a knife to a gun fight, and you don't bring PFS to an OS fight." This result provides a bit more confidence in tremelimumab, or at least keeps it from eroding further, but I would place good money on this combination having close to no impact on first line treatment patterns in advanced NSCLC.quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

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

Associate Clinical Professor, Medical Oncology Executi...

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...

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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...