Regeneron, Sanofi: Positive Libtayo Phase 3 Study in Advanced Cervical Cancer
March 15 2021 - 6:41AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 15, 2021 06:26 ET (10:26 GMT)
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