OBR Daily Commentary

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Janssen Announces ERLEADA® (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer

(J&J) Jan 30, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the unblinding of the Phase 3 TITAN study evaluating ERLEADA® (apalutamide) plus androgen deprivation therapy (ADT) in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The decision resulted from an Independent Data Monitoring Committee (IDMC) recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). Based on these results, the IDMC recommended that patients in the placebo plus ADT group be given the opportunity to cross over to treatment with ERLEADA plus ADT. Patients will continue to be followed for OS and long-term safety as part of the TITAN study.

Tomasz M. Beer, MD, FACP (Posted: January 31, 2019)

quotesThis study confirms one of the major trends in the field: that of intensifying upfront hormonal therapy in newly diagnosed metastatic prostate cancer. We have solid evidence that abiraterone or docetaxel improve outcomes when added to standard hormonal therapy early and now, apparently, similar results are being seen with apalutamide, an androgen receptor blocker. That is good news. We will eagerly await the full results as the magnitude of impact and the post-progression therapy experience of these patients will be an important determinant of how these results are interpreted in context.quotes

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Many Women Get Unnecessary Mammograms Before Breast Reduction Surgery

(U-M/M Health Lab) Jan 29, 2019 - Nearly one-third of younger women without a known cancer risk receive the screening before breast reduction surgery, a test that can do more harm than good. Each year, thousands of younger women with no known risk of breast cancer get mammograms before having breast reduction surgery. Patients receive the exam, often at the suggestion of their doctors, when the best recommendation says to avoid routine mammograms before elective breast surgery unless a specific concern exists.

Howard S. Hochster, MD (Posted: January 31, 2019)

quotesGood argument for tort reform. No surgeon wants to be in court for doing the wrong surgical procedure if an incidental breast cancer is found. Juries and plaintiffs don’t tend to accept guidelines in the face of actual damages to a person. quotes

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In Another Lung Cancer Setback, Bristol Yanks FDA App For Drug Combo

(Xconomy New York) Jan 24, 2019 - Bristol-Myers Squibb has lost yet more ground in its ongoing cancer immunotherapy battle with rival Merck. Along with its earnings, the pharma firm reported Thursday that it has pulled a key approval application to use a combo regimen of its already approved immunotherapies, nivolumab (Opdivo) and ipilimumab (Yervoy), in a portion of patients with newly diagnosed, advanced non-small cell lung cancer (NSCLC). Specifically, Bristol said that, upon discussions with the FDA, it needs more data to support the approval filing. The problem: Bristol needs to provide additional evidence for “the relationship between [tumor mutational burden] and PD-L1”—two biomarkers meant to help identify patients who might respond to immunotherapy—to really tell if the Bristol regimen is helping patients live longer.

H. Jack West, MD (Posted: January 24, 2019)

quotesWe are not privy to the data that the FDA have, but based on the TMB data that are publicly available, I think this is a very appropriate guidance by the FDA. We need more and stronger data to support TMB use for clinical decision-making. First, we need to see a survival benefit by using it; second, we need to see that the survival benefit is predicated on using the TMB test. I think it is more likely than not that TMB will be a useful biomarker, but not the only one, in a few years. However, the data we've seen from CheckMate-227 are not sufficient to warrant using it.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

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...