Phase III trial of Libtayo halted early on positive results

The Phase III trial of Libtayo (cemiplimab) in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC), according to French pharma major Sanofi (Euronext: SAN), which has been developing the drug in partnership with US biotech Regeneron’s (Nasdaq: REGN).

Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. These data are planned to form the basis of regulatory submissions in the USA and European Union.

“Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone,” said Dr Miranda Gogishvili, an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia, and a trial investigator. “Notably, the Phase III trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression,” she noted.