Benmelstobart With or Without Anlotinib Significantly Prolongs PFS in Advanced Non-Small Cell Lung Cancer
According to results from the phase 3 R-ALPS study, benmelstobart, a novel humanized IgG1 monoclonal antibody targeting PD-L1, with or without anlotinib significantly prolonged progression-free survival (PFS) among patients with advanced non-small cell lung cancer (NSCLC).
These data were first presented by Ming Chen, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this study, researchers enrolled 553 patients with locally advanced, unresectable stage 3 NSCLC who did not experience disease progression after treatment with concurrent or sequential chemoradiotherapy. Patients were randomized on a 1:1:1 basis to receive 1200 mg of benmelstobart once every 3 weeks with or without 8 mg of anlotinib once every 3 weeks on days 1 through 14 or placebo. The primary end point was PFS. A key secondary end point was safety.
At analysis, median PFS was 15.15 months in the combination arm, 9.69 months in the monotherapy arm, and 4.17 months in the placebo arm (hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39 to 0.72; P <.0001). The 12-month PFS rates were 54.9%, 45.7%, and 26.4%, respectively. Grade ≥ 3 treatment-emergent adverse events occurred in 8% of patients in the combination arm, 31.8% of patients in the monotherapy arm, and 21.2% of patients in the placebo arm. The most frequent events included hypertension and hypertriglyceridemia. Treatment-emergent adverse events led to treatment discontinuation in 5% of patients, 14.2% of patients, and 9.1% of patients, respectively. Treatment-related death due to treatment-emergent adverse events occurred in 2% of patients in the combination arm, 1% of patients in the monotherapy arm, and 0.8% of patients in the placebo arm.
“Benmelstobart, both as monotherapy and in combination with anlotinib, significantly prolonged PFS compared to placebo,” concluded Dr Chen et al. “Secondary end points also showed superiority, and the safety profile of the treatment group remained within acceptable parameters.”
Source:
Chen M, Ji Y, Chen L, et al. R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract LBA8004
