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# Libtayo Phase 3 in Lung Cancer Stopped Early
- URL: https://www.fdaweb.com/libtayo-phase-3-in-lung-cancer-stopped-early/
- Published: 2020-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:12:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146664

Sanofi and Regeneron Pharmaceuticals have stopped a Libtayo (cemiplimab) Phase 3 trial early after the primary endpoint of overall survival (OS) was met. The trial was comparing the PD-1 inhibitor to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer that tested positive for PD-L1 in more than 50% of tumor cells. Based on a recommendation by the independent data monitoring committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use, the companies say. The data will be used in submissions to FDA and European Union regulators later this year.

An interim analysis showed that patients treated with Libtayo monotherapy had a significant increase in OS, according to the companies. “Libtayo decreased the risk of death by 32.4% compared to platinum doublet chemotherapy, despite a third of patients entering the trial within the past six months and all chemotherapy patients being able to crossover to Libtayo if their disease progressed,” they say. No new Libtayo safety signal was identified.

Libtayo is currently approved in the U.S., European Union, and other countries for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.