Multicenter phase 3 trial of perioperative tislelizumab plus neoadjuvant chemotherapy for resectable NSCLC: final analysis of RATIONALE-315

The multicenter RATIONALE-315 trial in China randomized patients with resectable stage II-IIIA non-small cell lung cancer 1:1 to perioperative tislelizumab (n=226) or placebo (n=227), in combination with neoadjuvant chemotherapy. Final analysis of the trial, after median duration of follow-up of 38.5 months, has now been published. Median overall survival was not reached in either group, with 36-months OS rate 79.3% in the tislelizumab group versus 69.3% in the placebo group (HR 0.65; p=0.009). Median event-free survival was not reached in the tislelizumab group versus 30.6 months in the placebo group (HR 0.58; 95% CI 0.43-0.79). Survival benefits with tislelizumab were generally consistent across subgroups. The safety profile of tislelizumab plus chemotherapy was tolerable and consistent with known profiles of individual therapies. The authors conclude that neoadjuvant tislelizumab plus chemotherapy and adjuvant tislelizumab demonstrated a statistically significant and clinically meaningful OS benefit and sustained EFS improvement compared with neoadjuvant chemotherapy, with tolerable safety profile in patients with resectable stage II-IIIA NSCLC.