Regeneron announces follow-up results on Phase 3 EMPOWER-Lung 3 trial

Regeneron (REGN) Pharmaceuticals announced five-year follow-up results on overall survival from the Phase 3 EMPOWER-Lung 3 trial, which evaluated Libtayo plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer, NSCLC, with no EGFR, ALK or ROS1 aberrations. At this year’s WCLC, five-year efficacy results, with a median follow-up of 60.9 months, found Libtayo plus chemotherapy remained superior to chemotherapy alone: 21.1-month median OS versus 12.9 months, representing a 34% reduction in the risk of death. The five-year probability of survival was 19.4% for the Libtayo combination versus 8.8% for chemotherapy. 8.2-month median progression-free survival versus 5.5 months, representing a 42% reduction in the risk of disease progression. 43.6% objective response rate versus 22.1%. The ORR included a complete response rate of 6.4% versus 0%. 16.4-month median duration of response versus 7.3 months. Also presented at WCLC were exploratory subgroup analyses that demonstrated survival benefits for patients treated with Libtayo plus chemotherapy compared to chemotherapy alone regardless of tumor histology or PD-L1 expression level. Specific efficacy results included a: 22.3-month median OS among patients with squamous histology versus 13.8 months, representing a 32% reduction in risk of death. 19.4-month median OS among patients with non-squamous histology versus 12.4 months, representing a 38% reduction in risk of death. 24.0-month median OS among patients with PD-L1 greater than or equal to1% versus 12.1 months, representing a 46% reduction in risk of death.