OBR Daily Commentary

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Bayer to Showcase New Data from its Growing Cancer Portfolio at 2019 ASCO GU Cancers Symposium

(Bayer) Feb 5, 2019 - First presentation of data from the pivotal Phase III ARAMIS trial with the investigational compound darolutamide in patients with non-metastatic castration-resistant prostate cancer.

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Tomasz M. Beer, MD, FACP (Posted: February 05, 2019)

quotesDaralutamide would be the third agent with demonstrated efficacy in non-metastatic castration resistant prostate cancer if the ARAMIS trial yields positive results. Both efficacy and safety data will be of interest and clinicians evaluate a growing stable of options in this disease state where enzalutamide and apalutamide have been approved.quotes

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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.

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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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Gene-Expression Profiling Raises Costs for Cancer Care without Improving Outcomes for Low-Risk Breast Cancer Patients, According to Researchers

(NCCN) Jan 23, 2019 - Researchers from Yale School of Public Health find that genetic profiling for cancer tumors is cost-effective for high- and medium-risk patients with breast cancer, but is unlikely to make a meaningful impact on treatment for low-risk patients. New research in the January 2019 issue of JNCCN—Journal of the National Comprehensive Cancer Network reports that using Oncotype DX (ODX)—the most commonly used test for predicting the benefit of adjuvant chemotherapy to reduce the risk of disease recurrence—is not cost-effective for people with breast cancer who are otherwise at low-risk of recurrence. Multigene assays to obtain a gene-expression profile are laboratory tests used to identify the function of specific genes in cancer cells.

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Tomasz M. Beer, MD, FACP (Posted: January 23, 2019)

quotesThis is an excellent reminder that genomic testing is fundamentally no different from any other diagnostic intervention. The context of use matters and the authors should be applauded for their work confirming that in low risk patients, this assays should not be used. The speed with which knowledge is growing in this area will challenge us to frequently reassess the value of emerging diagnostics. New development may alter the value balance. But along the way, clinicians should embrace novel diagnostics when they make a valuable contribution and avoid them when they don't. 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...