OBR Daily Commentary

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FDA Approves Expanded Monotherapy Label for Merck’s KEYTRUDA® (pembrolizumab)

(Merck) Apr 11, 2019 - KEYTRUDA now approved for first-line treatment of patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (TPS ≥1%), with No EGFR or ALK genomic tumor aberrations. Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

H. Jack West, MD (Posted: April 12, 2019)

quotesThis new approval is more likely to lead to worse care rather than net benefit. The approval of pembrolizumab for patients with a lower threshold tumor PD-L1 of 1% is based on the KEYNOTE-042 trial being positive against chemo doublet alone in this broader population. However, pembrolizumab was already approved for patients with high PD-L1 of 50% of greater, and that group was the one that drove the positive results of the trial overall, essentially "carrying" the group with tumor PD-L1 1-49%, who did no better with pembro monotherapy than with doublet chemotherapy. The trial was positive despite having favorable results with pembro from the high PD-L1 group diluted by the extremely weak results with pembro monotherapy for the low PD-L1 group. Some will say that the fact that the first line pembrolizumab arm did just as well in overall survival as doublet chemo means that this now makes pembrolizumab a viable alternative. That might be the case except that the chemo alone arm was not permitted to cross over to immunotherapy upon progression, which has been a well established standard of care for years in patients with advanced NSCLC and who progressed after first line chemotherapy. The first line pembro arm only did as well as a hobbled, substandard of care arm that started with chemo and couldn't get subsequent immunotherapy. On the other hand, every patient who started on pembro could easily transition to chemo later. Finally, the inclusion of patients with stage III NSCLC who are not able to get chemo/radiation is another concern, since the current standard of care in this setting, chemoradiation followed by durvalumab, is a potentially curative therapy. These were not patients who were the planned subjects of KEYNOTE-042. For patients with stage III NSCLC to receive single agent pembrolizumab rather than chemoradiation would be an egregious affront to our best data-driven standards.quotes

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PBM Middlemen Continue to Dodge Responsibility for Patient Suffering and Rising Drug Prices

(COA) Apr 9, 2019 - COA applauds the senate finance committee for PBM hearing as part of national efforts to shed light on PBM abuses and lower drug prices. More investigation and oversight needed to examine adverse impact of PBM abuses on patient care.

Ted Okon (Posted: April 11, 2019)

quotesPBMs are getting more brazen in how they delay and deny cancer patients their oral drugs. Anyone in practice knows that. The Senate Finance hearing was a necessary first step but a lot more needs to be done — especially focusing on how PBMs are adversely impacting patient care.quotes

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ASCO Announces New Task Force To Address Rural Cancer Care Gap

(ASCO in Action) Apr 10, 2019 - Today at the National Press Club, the American Society of Clinical Oncology (ASCO) announced a new task force aimed at reducing disparities and improving outcomes for patients and survivors of cancer who live in rural communities. The new “Rural Cancer Care Task Force” will identify opportunities to close the rural cancer care gap and implement strategies to improve rural cancer care in the United States.

Parity of Medicare Reimbursement is needed (Posted: April 11, 2019)

quotesWhen the Medicare fee schedule pays the same for clinic-based as well as hospital-based services, that will be a good first step in improving rural access to care. Free-standing satellite oncology clinics cannot remain open when they are forced by CMS to bill as clinic-based operation. It doesn't pay for the drugs. 340(b) doesn't apply to satellite operations, when the "mother ship" institution is not in a 340(b) zip code.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
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Jeff Patton, M.D.

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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.

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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...

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Ted Okon

Executive Director Community Oncology Alliance...

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Thomas Marsland, MD

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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...

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Winston Wong, PharmD

President, W-Squared Group...