OBR Daily Commentary

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The Lancet Publishes Libtayo® (cemiplimab) Data Showing Extended Overall Survival in Patients With First-line Advanced Non-Small Cell Lung Cancer With PD-L1 Expression of ³50%

(Sanofi) Feb 12, 2021 - The Lancet today published results from a pivotal trial designed to evaluate the investigational use of the PD-1 inhibitor Libtayo® (cemiplimab) compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression in tumor cells. The data were shared during a late-breaking presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress and formed the basis of regulatory submissions in the U.S. and European Union (EU). The U.S. Food and Drug Administration (FDA) granted a Priority Review with a target action date of February 28, 2021. A European Commission decision is expected by mid-2021.

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H. Jack West, MD (Posted: February 12, 2021)

quotesAs the third entrant in the same clinical setting to show a survival benefit over a quite outdated comparator arm of chemotherapy alone, cemiplimab fails to demonstrate any meaningful incremental benefit over pembrolizumab as the current standard of care in this setting or atezolizumab as a similarly active but already arguably redundant alternative here. I strongly suspect that clinicians will not see a compelling reason to change their current preference in this setting, absent a marked cost difference in favor of cemiplimab to offer a point of differentiation.quotes

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FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations

(Merck KGaA) Feb 3, 2021 - Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO® (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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H. Jack West, MD (Posted: February 04, 2021)

quotesIt's good to get another approval in NSCLC, and tepotinib has high efficacy and generally very good tolerability in MET exon 14 skipping mutation-positive NSCLC, but this is also a setting in which we already have capmatinib, which has very similar efficacy and tolerability. There are a small fraction of patients who can't tolerate one but may do better with another, but I must confess that the utility of a second agent in the same space offers limited incremental benefit, at least unless we learn that patients can respond to one after progressing on the other, which I would suspect is not the case.quotes

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LCMC3 Findings Indicate Neoadjuvant Atezolizumab Safe, Efficacious in Resectable Stage IB-IIIB NSCLC

(IASLC) Jan 28, 2021 - Primary results of the phase II Lung Cancer Mutation Consortium (LCMC) 3 clinical trial suggest that neoadjuvant atezolizumab may be a worthwhile treatment option for selected patients with resectable stage IB-IIIB NSCLC (Abstract PS01.05). Not only did 21% of patients lacking EGFR or ALK genetic aberrations attain a major pathologic response (MPR) at the time of resection, thus meeting the primary endpoint of the study, but 7% achieved a pathologic complete response (pCR). Moreover, 43% of 155 evaluable patients were downstaged followed neoadjuvant atezolizumab, whereas 19% were upstaged.

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H. Jack West, MD (Posted: February 01, 2021)

quotesWe're going to need to see benefits with real endpoints that patients care about in order to clarify how encouraging this approach is. The risks here were not trivial -- some patients had progression and upstaging despite immunotherapy, there were some toxicities and concern for potential complications -- and comparing how a selected group of patients enrolled onto a trial at a few tertiary care academic centers did compared to thousands of historical controls from everywhere is just misleading. While there is a prevalent bias to promote the role of immunotherapy in early stage disease despite very thin evidence thus far, at some point we need to see that patients who get immunotherapy actually have a significant improvement in survival before we adopt an extremely expensive therapy that has potential for serious and even permanent adverse effects for patients.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 Professo...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Steven Spielberg Family Chair in Hematology Oncology P...

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Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

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 ...

Health Policy
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William McGivney, PhD

National Health Policy Expert...