Article
作者: Yu, X. ; Lin, X. ; Leaw, S. ; Liang, L. ; Sun, M ; Wang, J ; Yu, Y ; Zhao, J. ; Lin, X ; Song, Y ; Zheng, W ; Hu, C ; Wang, J. ; Yang, K ; Song, Y. ; Sun, M. ; Yu, Y. ; Liang, L ; Leaw, S ; Lu, S. ; Yang, K. ; Lu, S ; Hu, C. ; Yu, X ; Zhao, J ; Hu, Y. ; Zheng, W. ; Hu, Y
PURPOSE:First-line tislelizumab plus chemotherapy significantly improved progression-free survival (PFS) versus chemotherapy alone in advanced squamous non-small-cell lung cancer (sq-NSCLC) at the interim analysis of the phase III RATIONALE-307 trial. We present the final analysis of this trial.
PATIENTS AND METHODS:Patients with treatment-naive, stage IIIB/IV, sq-NSCLC were randomized (1 : 1: 1) to 21-day cycles of i.v.: tislelizumab plus paclitaxel and carboplatin (arm A); tislelizumab plus nab-paclitaxel and carboplatin (arm B); or paclitaxel and carboplatin (arm C). The primary endpoint was independent review committee-assessed PFS; overall survival was a secondary endpoint.
RESULTS:In total, 360 patients were randomized; 355 received treatment. At the final analysis (median study follow-up: 16.7 months), tislelizumab plus chemotherapy had a manageable safety profile, consistent with that at the interim analysis. Improvement in PFS was maintained for arms A and B versus C {hazard ratio (HR) 0.45 [95% confidence interval (CI) 0.33-0.62] and 0.43 (95% CI 0.31-0.60), respectively}. Overall survival HRs for arms A and B versus C were 0.68 (95% CI 0.46-1.01) and 0.75 (95% CI 0.50-1.12), respectively.
CONCLUSIONS:The RATIONALE-307 final analysis demonstrated superior clinical benefit with addition of tislelizumab to chemotherapy, and a manageable safety profile, as first-line treatment of advanced sq-NSCLC.