A MAJOR phase 3 lung cancer trial investigating the TGIT-targeting immunotherapy ociperlimab has been halted after interim analysis indicated it would not meet its primary endpoint of overall survival. This marks the end of the clinical program for ociperlimab in the treatment of non-small cell lung cancer (NSCLC), a development closely watched by oncologists and clinical researchers across the U.S.
Ociperlimab (BGB-A1217) is an investigational humanized IgG1 monoclonal antibody designed to enhance antitumor immunity by blocking the T-cell immunoreceptor with Ig and ITIM domains (TGIT) pathway. It was being evaluated in combination with tislelizumab in the randomized, double-blind phase 3 AdvanTIG-302 trial (NCT04746924). The study enrolled treatment-naïve patients with locally advanced, unresectable, or metastatic NSCLC who had high PD-L1 expression and lacked EGFR-sensitizing mutations or ALK translocations.
Participants were randomized to receive either ociperlimab plus tislelizumab, tislelizumab alone, or pembrolizumab monotherapy. However, following a pre-planned futility analysis, the Independent Data Monitoring Committee recommended terminating the trial early. According to the study sponsor, both efficacy and safety data suggested the likelihood of achieving a significant overall survival benefit was low.
The trial’s early closure highlights the ongoing challenges of translating immunologic theory into durable patient outcomes. Detailed trial findings are expected to be shared at an upcoming medical meeting.
Reference: MPR. Ociperlimab Lung Cancer Clinical Program Halted After Trial Failure. April 3, 2025. Available at: https://www.empr.com/news/ociperlimab-lung-cancer-clinical-program-halted-after-trial-failure/. Last accessed: April 4, 2025.
