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Regeneron, Sanofi Stop Phase III Libtayo Trial Early Due to Efficacy in Lung Cancer

NEW YORK – Sanofi and Regeneron announced on Monday that they were stopping a Phase III trial of PD-1 inhibitor cemiplimab (Libtayo) early after it met its primary endpoint of improving overall survival over platinum doublet chemotherapy in first-line, PD-L1-positive advanced non-small cell lung cancer patients.

In the trial, PD-L1-positive patients were described as those who had greater than 50 percent of PD-L1 expression in tumor cells as determined by a commercially available assay performed by a central laboratory. The companies stopped the trial based on the recommendation of an independent data monitoring committee, and now they will allow all patients in the trial to receive cemiplimab.

Interim analysis found that there was a 32.4 percent decrease in the risk of death for patients treated with cemiplimab monotherapy compared to patients in the chemotherapy arm. The companies said they intended to present detailed trial data at a future medical meeting.

Cemiplimab was discovered by Regeneron and is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. The data from this Phase III trial will support regulatory submissions in the US and the EU in 2020.

Previously, cemiplimab has been approved in the US, EU, and other countries for advanced or metastatic cutaneous squamous cell carcinoma that doesn't qualify for curative surgery or radiation.

Cemiplimab is being investigated in several other solid tumors and blood cancers including a "potentially registrational Phase III trial in cervical cancer," the companies said in a statement.