Study of Tislelizumab/Chemo Meets Primary End Points in Resectable NSCLC
Tislelizumab with chemotherapy significantly improved MPR and EFS in resectable stage II/IIIA NSCLC compared to chemotherapy alone.
A phase 3, randomized, double‑blind, placebo‑controlled trial (RATIONALE 315, NCT04379635) evaluated neoadjuvant tislelizumab plus platinum‑based chemotherapy followed by surgery and post‑operative tislelizumab as single agent versus placebo control in patients with resectable stage II or IIIA non‑small‑cell lung cancer (NSCLC). The study met the dual primary end points of major pathological response (MPR) and event‑free survival (EFS) and demonstrated clinically meaningful improvements in MPR (56.2% vs 15.0%, difference 41.1 %) and pathological complete response (pCR; 40.7% vs 5.7%, difference 35.0 %). The combination was generally well‑tolerated with no new safety signals.
Early integration of immunotherapy in the neoadjuvant setting can enhance tumor response and reduce recurrence risk in resectable NSCLC, offering a new therapeutic strategy to improve long‑term outcomes.
Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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