Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer
Serplulimab plus chemotherapy significantly improves overall survival compared with placebo plus chemotherapy in patients with extensive‑stage small cell lung cancer (SCLC).
This international, double‑blind, phase‑3 randomized clinical trial (ASTRUM‑005) evaluated the efficacy and adverse event profile of the PD‑1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first‑line treatment in patients with extensive‑stage small cell lung cancer. A total of 585 previously untreated patients were randomized in a 2:1 ratio to serplulimab (n=389) or placebo (n=196) plus intravenous carboplatin and etoposide every 3 weeks. The primary outcome was overall survival. Median overall survival was 15.4 months in the serplulimab group versus 10.9 months in the placebo group (hazard ratio, 0.63; 95% CI, 0.49‑0.82; P < 0.001). Progression‑free survival was also longer with serplulimab (5.7 months vs 4.3 months; hazard ratio, 0.48; 95% CI, 0.38‑0.59).
Programmed cell death ligand 1 (PD‑L1) inhibitors combined with chemotherapy have changed the standard of care for first‑line treatment of extensive‑stage small cell lung cancer. However, whether a programmed cell death 1 (PD‑1) inhibitor could provide similar or greater benefit when added to chemotherapy was unknown, leaving a gap in evidence for optimal therapeutic strategy in this aggressive disease. This study addresses that uncertainty by testing serplulimab, a PD‑1 inhibitor, in the first‑line setting for extensive‑stage SCLC.
Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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