Regeneron, Sanofi: Libtayo Phase 3 Study Meets Primary Endpoint
August 05 2021 - 7:57AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. and Sanofi SA on Thursday said a
Phase 3 study of their anti-PD-1 cancer drug Libtayo met its
overall-survival primary endpoint in patients with advanced
non-small cell lung cancer, prompting the companies to end the
trial early.
The companies said adding Libtayo to platinum-doublet
chemotherapy significantly improved overall survival compared to
chemotherapy alone in the study, which enrolled patients with
metastatic or locally advanced disease and tumors with either
squamous or non-squamous histology and across all PD-L1 expression
levels.
Libtayo combined with chemotherapy increased median overall
survival to 22 months from 13 months, leading to a 29% reduction in
the risk of death, the companies said.
Regeneron and Sanofi said the decision to stop the trial early
is based on a recommendation by the study's independent data
monitoring committee during a protocol-specified interim analysis,
adding that the study data will form the basis of regulatory
submissions in the U.S. and European Union.
Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly
developing and commercializing Libtayo under a global collaboration
agreement.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 05, 2021 07:42 ET (11:42 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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