DISCLAIMER

The contents of the presentations above are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and/or efficacy for such investigational products or uses may be made.

 
SUMMARY

This post hoc analysis of the Phase 3 RATIONALE‑315 trial evaluated the association between event‑free survival (EFS) and surgical outcomes in patients with resectable stage II–IIIA non‑small cell lung cancer treated with perioperative tislelizumab or placebo plus neoadjuvant chemotherapy. A total of 453 patients were randomized 1:1, and as of March 7, 2025, definitive surgery was performed in 190/226 patients in the tislelizumab arm and 173/227 patients in the placebo arm. An EFS benefit with tislelizumab versus placebo was observed across surgically relevant subgroups (hazard ratio, 0.62; 95% CI, 0.44–0.88). Although R0 resection rates were similar between treatment arms, EFS favored tislelizumab over placebo in patients achieving R0 resection (hazard ratio, 0.62; 95% CI, 0.43–0.90), with a similar trend observed in patients with R1/R2 resections, noting limited patient numbers. Among patients undergoing minimally invasive and open surgery, respectively, Grade ≥3 treatment‑emergent adverse events occurred in 77.2% and 78.8% of patients in the tislelizumab arm and 71.3% and 81.7% of patients in the placebo arm.

 
ClinicalTrials.gov ID: NCT04379635