AdvanTIG-302 trial

Background

Randomized phase 3 (N=662 at interim analysis). Untreated, locally advanced unresectable or metastatic (stage III/IV) NSCLC with PD-L1 ≥50%, no EGFR/ALK alterations. Tested dual TIGIT + PD-1 blockade: ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) vs pembrolizumab; 5:5:2 randomization with a tislelizumab monotherapy reference arm.

Results

Interventions and follow up: Arm A: Ociperlimab 900 mg IV + tislelizumab 200 mg IV q3wk
Arm B: Pembrolizumab 200 mg IV q3wk
Arm C: Tislelizumab 200 mg IV q3wk (reference arm)
Primary endpoint: OS (Arm A vs B)
mFollow up: NR (interim analysis; data cutoff May 30, 2025)
Results: Trial terminated for futility at prespecified interim analysis; all efficacy analyses descriptive.
OS: 31.9 (A) vs 29.4 (B) mo (stratified HR 0.97; 95% CI 0.76-1.23); Arm C 27.7 mo
PFS: 14.3 (A) vs 10.5 (B) vs 16.6 (C) mo
ORR: 61.0% (A) vs 48.8% (B) vs 55.7% (C)

Adverse events

TRAEs (any): 84.3% (A) vs 79.4% (B) vs 79.3% (C)
Grade ≥3 breakdown: NR in abstract
New safety signals: none

Conclusions

Ociperlimab + tislelizumab increased response rate and numerically prolonged PFS but did not improve OS over pembrolizumab (HR 0.97); the trial was stopped for futility. Another definitive anti-TIGIT failure in PD-L1-high NSCLC.

Key Limitations

Terminated at interim for futility, so all efficacy comparisons are descriptive; ORR/PFS gains without OS movement suggest absent true synergy; PD-L1 ≥50% alone appears inadequate to select for TIGIT benefit; tislelizumab reference arm (5:5:2) small and not powered for formal comparison.

Clinical Context

Joins SKYSCRAPER-01 (tiragolumab) and other failed anti-TIGIT programs; the ociperlimab lung cancer clinical program has been terminated by the sponsor. Pembrolizumab monotherapy (KEYNOTE-024/-042) remains a 1L standard for PD-L1 ≥50% NSCLC; no anti-TIGIT agent is approved.

References