Regeneron, Sanofi: Positive Libtayo Phase 3 Study in Advanced Cervical Cancer

By Colin Kellaher

Regeneron Pharmaceuticals Inc. and Sanofi SA on Monday said they are stopping a Phase 3 study of their anti-PD-1 cancer drug Libtayo early due to positive results in advanced cervical cancer.

The companies said Libtayo is the first immunotherapy to show improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy.

Regeneron and Sanofi said the trial, which is investigating Libtayo monotherapy compared with chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, will be stopped early based on a recommendation by the independent data monitoring committee, adding that data from the study will form the basis of regulatory submissions this year.

Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly developing and commercializing Libtayo under a global collaboration agreement.

The U.S. Food and Drug Administration in February approved the expanded use of Libtayo to include the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have with programmed death-ligand 1, or PD-L1, expression of at least 50%. The drug also is approved for some patients with basal cell carcinoma and advanced cutaneous squamous cell carcinoma.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 15, 2021 06:26 ET (10:26 GMT)

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