EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer

March 6, 2023

Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The recommendation comes as the company releases promising phase III clinical trial data.

According to Krista Rosa, “The positive opinion is based on data from the phase 3 Study 16113/EMPOWER-Lung 3 trial (NCT03409614). Of the 466 patients enrolled to the trial, 327 had tumors with a PD-L1 expression of at least 1%. In this subgroup, cemiplimab plus chemotherapy (n = 217) resulted in a median overall survival (OS) of 22 months vs 13 months with chemotherapy alone (n = 110) at a median follow-up of 16 months; this translated to a 45% relative reduction in the risk of death (HR, 0.55; 95% CI, 0.39-0.78). With a longer median follow-up of 28 months, cemiplimab/chemotherapy continued to showcase a meaningful survival benefit in this group (HR, 0.51; 95% CI, 0.38-0.69).”

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