PD-1/ PD-L1 bispecific antibody IBI318 combined with lenvatinib in advanced non-small cell lung cancer with acquired resistance to immune checkpoint inhibitors: a phase II trial.

ABSTRACT: Immune checkpoint inhibitors (ICIs) have improved survival in advanced non-small cell lung cancer (NSCLC), yet resistance remains a major challenge. Here, we report the results from cohort A of a multi-cohort, phase II, open-label trial [NCT04777084], evaluating the efficacy and safety of IBI318 (a bispecific anti-PD-1/PD-L1 antibody, 300 mg intravenous every 2 weeks) plus lenvatinib (a receptor tyrosine kinase inhibitor, 8 mg orally daily). Forty patients with advanced NSCLC and acquired resistance to first-line ICIs were enrolled and received at least 1 cycle of the study regimen. The primary endpoint of 12-week objective response rate was 40.0% (95% CI: 24.9-56.7), satisfying prespecified efficacy threshold. Secondary endpoints included other efficacy endpoints and safety. Median progre

SUBMITTER: Zeng L 

PROVIDER: S-EPMC12808239 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature