First-Line Sugemalimab Plus Chemotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
According to updated results from the phase 3 GEMSTONE-302 trial, sugemalimab, a PD-L1 inhibitor, plus platinum-based chemotherapy demonstrated long-term efficacy and safety among patients with metastatic non-small cell lung cancer (NSCLC).
In this double-blind trial, 479 treatment-naive patients with stage IV squamous or non-squamous NSCLC were randomized on a 2-to-1 basis to either 1200 mg of sugemalimab (n = 320) or placebo (n = 159) plus platinum-based chemotherapy for up to 4 cycles. Treatment was followed with up to 35 cycles of sugemalimab or placebo maintenance (with pemetrexed in non-squamous patients). The primary end point was investigator-assessed progression-free survival (PFS). Key secondary end points included median treatment duration, overall survival (OS), and safety.
With a median follow up of 43.5 months in the sugemalimab arm and 43.0 months in the placebo arm, the median treatment durations were 7.2 months and 4.6 months, respectively. Median PFS was 9 months and 4.9 months, respectively. Median OS was 25.2 months in the sugemalimab arm and 16.9 months in the placebo arm and the 4-year OS rates were 32.1% and 17.3%, respectively. The most common grade 3/4 treatment-related adverse events included neutrophil count decrease, white blood cell count decrease, anemia, and platelet count decrease. Serious treatment-related adverse events occurred in 26% of patients in the sugemalimab arm and 20% of patients in the placebo arm.
“These results underscore the efficacy of sugemalimab plus platinum-based chemotherapy as a standard first-line treatment option for both squamous and non-squamous metastatic NSCLC while maintaining a manageable safety profile,” concluded Dr Zhou et al.
Source:
Zhou C, Wang Z, Sun M, et al. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): Four-year outcomes from a double-blind, randomised, phase 3 trial. Lancet Oncol. Published online: June 13, 2025. doi: 10.1016/S1470-2045(25)00198-6
