Phase 3 trial of Libtayo (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

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On Apr. 27, 2020, Regeneron and Sanofi announced the primary endpoint of overall survival was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo (cemiplimab) to platinum-doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer that tested positive for PD-L1 in =50% of tumor cells.

Based on a recommendation by the Independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use. The data will form the basis of regulatory submissions in the U.S. and EU in 2020.

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Source: Regeneron
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