Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) on Tuesday announced five-year follow-up results on overall survival (OS) from the Phase 3 EMPOWER-Lung 3 trial of Libtayo (cemiplimab) 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.
The data were presented at the World Conference on Lung Cancer (WCLC).
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 overall survival versus 12.9 months, representing a 34% reduction in the risk of death (hazard ratio [HR]: 0.66).
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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 (PFS) versus 5.5 months, representing a 42% reduction in the risk of disease progression (HR: 0.58).
43.6% objective response rate (ORR) versus 22.1%. The ORR included a complete response rate of 6.4% versus 0%.
16.4-month median duration of response (DoR) versus 7.3 months.
The company also presented exploratory subgroup analyses at WCLC that demonstrated survival benefits for patients treated with Libtayo plus chemotherapy compared to chemotherapy alone, regardless of tumor histology or PD-L1 expression level.
22.3-month median overall survival among patients with squamous histology (n=133) versus 13.8 months (n=67), representing a 32% reduction in risk of death (HR: 0.68).
The 19.4-month median OS among patients with non-squamous histology (n=179) was lower than the 12.4-month median OS (n=87), representing a 38% reduction in the risk of death.
24.0-month median OS among patients with PD-L1 ≥1% versus 12.1 months (n=110), representing a 46% reduction in risk of death.
Price Action: REGN stock is up 0.03.% at $558.63 at the last check Tuesday.
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