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# Trial Stopped Early on Libtayo in Cervical Cancer
- URL: https://www.fdaweb.com/trial-stopped-early-on-libtayo-in-cervical-cancer/
- Published: 2021-03-15T12:00:00.000Z
- Updated: 2026-09-14T16:50:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148879

Sanofi and Regeneron are stopping early a Phase 3 clinical trial on PD-1 inhibitor Libtayo (cemiplimab) based on positive data and now plan an FDA submission later this year for treating cervical cancer. The data showed an overall survival benefit for Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, according to the companies.

The trial’s early stoppage was also based on a unanimous recommendation by its independent data monitoring committee. In the trial, compared to chemotherapy, patients receiving Libtayo experienced a 31% reduced risk of death, with a median 12.0 months survival for Libtayo (n=304) compared to 8.5 months for chemotherapy.

Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. “By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation,” the companies say. Libtayo is currently approved as monotherapy for certain patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression. It is also approved for certain patients with basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, and as a systemic treatment for certain patients with advanced cutaneous squamous cell carcinoma.