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Published on: September 25, 2018
AdvanTIG-302: Phase 3 Study of Ociperlimab (Anti-TIGIT) Plus Tislelizumab (Anti-PD-1) Versus Pembrolizumab in
Mark A Socinski1, Martin Reck2, Luis Paz-Ares3
1AdventHealth Cancer Institute, Orlando, Florida.
Introduction:
Novel agents that improve outcomes in NSCLC are needed. Co-inhibition of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitor motif domains and programmed cell death protein 1 (PD-1) may enhance anti-PD-1 activity. AdvanTIG-302 is a phase 3 trial of ociperlimab plus tislelizumab (A), pembrolizumab (B), and tislelizumab (C) in first-line stage III/IV NSCLC with programmed cell death-ligand 1 expression of 50% or more (NCT04746924).
Methods:
Eligible patients were randomized (5:5:2) to A, B, or C. The primary objective was overall survival (OS) in A versus B; key secondary analyses were progression-free survival (PFS) and overall response rate (ORR).
Results:
As of May 30, 2025, the prespecified interim analysis (N = 662) was terminated due to futility; efficacy analyses are descriptive only. Median OS (95% confidence interval [CI]) was 31.9 (25.7-not estimable [NE]), 29.4 (25.8-35.0), and 27.7 (20.0-NE) months for arms A, B, and C, respectively; the stratified hazard ratio for A versus B was 0.97 (95% CI: 0.76-1.23). For A, B, and C, median PFS (95% CI) was 14.3 (11.5-16.0), 10.5 (8.4-12.6), and 16.6 (8.9-26.3) months and ORR (95% CI) was 61.0% (55.1-66.7), 48.8% (42.9-54.7), and 55.7% (44.7-66.3), respectively. In arms A, B, and C, treatment-related adverse events occurred in 84.3%, 79.4%, and 79.3% of patients, respectively.
Conclusion:
Ociperlimab plus tislelizumab had no improvement in OS compared with pembrolizumab; median OS was comparable across arms. Data for B versus C should be interpreted cautiously given the descriptive nature of this comparison. The safety profiles of all treatment arms were well tolerated, with no new safety signals.
Insights
Ociperlimab plus tislelizumab did not improve overall survival compared to pembrolizumab in advanced non-small cell lung cancer. Survival outcomes were similar across all treatment arms, with well-tolerated safety profiles.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Novel therapeutic strategies are crucial for improving outcomes in non-small cell lung cancer (NSCLC).
- Co-inhibition of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitor motif domains (TIGIT) and programmed cell death protein-1 (PD-1) may enhance anti-PD-1 therapy.
- The AdvanTIG-302 trial investigated ociperlimab plus tislelizumab in first-line advanced NSCLC.
Purpose of the Study:
- To evaluate the efficacy of ociperlimab plus tislelizumab compared to pembrolizumab in first-line stage III/IV NSCLC with high PD-L1 expression.
- Primary endpoint was overall survival (OS) in arm A versus arm B.
- Secondary endpoints included progression-free survival (PFS) and overall response rate (ORR).
Main Methods:
- Phase 3, randomized trial (AdvanTIG-302) with a 5:5:2 allocation ratio.
- Patients received ociperlimab plus tislelizumab (Arm A), pembrolizumab (Arm B), or tislelizumab (Arm C).
- Interim analysis of 662 patients was conducted, with efficacy analyses being descriptive.
Main Results:
- The interim analysis was terminated due to futility; efficacy data are descriptive.
- Median OS was comparable across arms: 31.9 months (Arm A), 29.4 months (Arm B), and 27.7 months (Arm C).
- Median PFS: 14.3 months (A), 10.5 months (B), 16.6 months (C). ORR: 61.0% (A), 48.8% (B), 55.7% (C).
Conclusions:
- Ociperlimab plus tislelizumab did not demonstrate improved OS compared to pembrolizumab.
- Overall survival was comparable across all treatment arms.
- All treatment regimens exhibited well-tolerated safety profiles without new safety signals.
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