EU approves Libtayo plus chemo for non-small cell lung cancer

The EC approval is based on data from the global Phase III EMPOWER-Lung 3 trial, a randomized, multicenter trial investigating a first-line combination treatment of Libtayo and platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, as well as squamous or non-squamous histologies across all PD-L1 expression levels and with no EGFR, ALK or ROS1 aberrations. Notably, the trial was designed to closely resemble a patient population with varied disease presentations seen in everyday clinical practice. Among those enrolled, 43% had tumors with squamous histology, 15% had locally advanced disease and 7% had a history of brain metastases.

Among the 70% of patients in the trial expressing PD-L1 at least 1% (n=327), efficacy results for the Libtayo combination arm (n=217) compared to chemotherapy alone (n=110) showed a 22-month median OS versus 13 months, representing a 45% relative reduction in the risk of death (HR: 0.55; 95% CI: 0.39 to 0.78) plus a 9-month median progression-free survival (PFS) versus 6 months (HR: 0.48; 95% CI: 0.36 to 0.63) and a 48% objective response rate (ORR) versus 23%. It also showed a 16-month median duration of response (DOR; range: 2 to 19+) versus 5 months (range: 2 to 19+).