Phase 3 RCT (AdvanTIG-302) comparing ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) vs. pembrolizumab vs. tislelizumab alone as first-line therapy in adults with stage III/IV NSCLC and PD-L1 ≥50% (N=662; data cutoff May 30, 2025).
The interim analysis was terminated early for futility. Median OS was 31.9 vs. 29.4 months (ociperlimab + tislelizumab vs. pembrolizumab; HR 0.97, 95% CI 0.76–1.23). ORR was higher in Arm A (61.0%) vs. Arm B (48.8%), but this did not translate to an OS benefit.
- Trial stopped at interim for futility; all efficacy comparisons are descriptive only, limiting interpretability. - The tislelizumab-alone arm (Arm C) comparison vs. pembrolizumab is not powered and must be interpreted with caution. - Median OS for Arm A and C had an upper CI of 'not estimable,' suggesting immature survival data.
Adding ociperlimab (anti-TIGIT) to tislelizumab did not improve OS over pembrolizumab in first-line PD-L1 ≥50% NSCLC; pembrolizumab monotherapy remains the standard of care. Anti-TIGIT combinations in this setting have now failed in multiple phase 3 trials.
