Sanofi: FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of =50% N=356 a 14 months Median (95% CI) b Based on stratified proportional hazards model An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of =50%, according to the FDA-approved assay, and is described in the updated labeling of the FDA-approved assay (and also recently published (https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-12-07-00-00) in The Lancet). This analysis showed that Libtayo reduced the risk of death by 43% compared to chemotherapy, with additional efficacy results as follows: Endpoints