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.

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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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Maintenance Immunotherapy Fails To Improve Survival In Extensive Small Cell Lung Cancer

(ELCC 2019) Apr 11, 2019 - Maintenance immunotherapy fails to improve survival in extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study to be presented today at the European Lung Cancer Congress 2019. Around 60–70% of patients with SCLC have extensive disease at the time of diagnosis, meaning it has spread beyond a single lung and nearby lymph nodes and cannot be treated with radiotherapy.

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H. Jack West, MD (Posted: April 11, 2019)

quotesA disappointing failure, but one that at least leaves the new standard of first line carbo/etoposide/atezolizumab, which showed a survival benefit over chemo alone in the IMpower133 trial, as an uncontested leading approach today. Surprising to see such weak results even for the nivolumab/ipilumumab doublet, but the fact that there's a suggested benefit on the far right end of the curve highlights that there is a subgroup who do well with immunotherapy -- we just need to figure out how to identify them prospectively.quotes

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Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients

(BMS) Apr 2, 2019 - Bristol-Myers Squibb Company today announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously-treated advanced non-small cell lung cancer (NSCLC) who were treated with Opdivo (nivolumab). In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 ≥1% and <1%, four-year overall survival (OS) rates were 19% and 11%, respectively. In the pooled analysis of the two phase 3 trials, CheckMate -017 and -057, the four-year OS rate for Opdivo-treated patients was 14% compared to 5% for docetaxel-treated patients. Additionally, exploratory landmark analysis of OS found that of patients who had a complete or partial response at six months, 58% of those treated with Opdivo were alive four years later vs. 12% of patients treated with docetaxel.

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H. Jack West, MD (Posted: April 03, 2019)

quotesNice to see further long-term survival data, really in keeping with what we've seen up to now. There are a significant minority of patients who continue to demonstrate prolonged survival far beyond what we'd seen before the era of immune checkpoint inhibitor therapy in advanced NSCLC. That said, the world has shifted to using immunotherapy agents primarily first line in advanced NSCLC. These data don't suggest any change in management or our thinking.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...