Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company announced on Saturday that it has updated the Phase 1b efficacy and safety results of IBI939 (anti-TIGIT antibody) combined with sintilimab (anti-PD-1 antibody) in earlier untreated PD-L1-selected NSCLC without sensitising mutations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

IBI939, an IgG4k recombinant fully human anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody, has been developed by Innovent Biologics.

This Phase 1b study is intended to assess safety, tolerability, and efficacy of combination therapy of IBI939 with sintilimab in subjects with previously untreated, locally advanced unresectable or metastatic PD-L1 TPS greater than or equal to 50 NSCLC without sensitising mutations (clinicalTrials.gov, NCT04672369).

Effective 1 January 2023, 42 pts were randomised (2:1) to receive IBI939 and sintilimab (experimental arm, n=28) or sintilimab monotherapy (control arm, n=14).

The study results revealed median progression free survival (PFS) follow-up of 12.2 months in the experimental arm and 11.3 months in the control arm, respectively, median PFS per investigator was 13.2 months (95% CI: 6.7-16.5) and 6.4 months (95% CI: 1.4-NA), and the hazard ratio (HR) between two arms was 0.62. It also indicated that 96.4% of subjects in the experimental arm and 71.4% of subjects in the control arm experienced treatment-related adverse event (TRAE). Each arm occurred one treatment-emergent adverse event (TEAE) resulting in the end of treatment, and no TEAE leading to death occurred in the experimental arm.

Outcome from this updated evaluation following longer follow-up indicated that IBI939 plus sintilimab combination therapy had continued efficacy and manageable safety profile in previously untreated PD-L1 TPS greater than or equal to 50% NSCLC without sensitising mutations.