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.

Abstract

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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