OBR Daily Commentary


FDA Approves Cemiplimab-rwlc For Non-Small Cell Lung Cancer With High PD-L1 Expression

(FDA.gov) Feb 22, 2021 - On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. Efficacy was evaluated in Study 1624 (NCT03088540), a multi-center, randomized, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC.

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H. Jack West, MD (Posted: February 23, 2021)


This approval now gives us a third option for the same clinical setting in which we already have pembrolizumab as a clear standard of care since it demonstrated significant superiority to chemotherapy alone in 2016. We also have atezolizumab that showed the same thing and currently serves as a rarely used understudy to pembrolizumab here, with no incremental benefit. Cemiplimab provides only further redundancy here. We should also reflect on the questionable ethics of running a trial that assigns half of the patients to a treatment that had been proven inferior to single agent immunotherapy from KEYNOTE-024 before the new trial started.

Unfortunately, history has shown us that we should not expect the addition of more agents in the same setting to lead to improvements in pricing. I strongly suspect Regeneron will fail to price cemiplimab significantly lower than pembrolizumab or atezolizumab, which is the only factor that could differentiate it from better established competition in this market.



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