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Neoadjuvant Tislelizumab Plus Chemotherapy Followed by Adjuvant Tislelizumab Significantly Improved Survival Benefit Among Patients With Non-Small Cell Lung Cancer
According to interim analysis results from the phase 3 RATIONALE-315 study, neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab significantly improved the event-free survival (EFS) and overall survival (OS) among patients with treatment-naïve, resectable, stage II to IIIA non-small cell lung cancer (NSCLC).
This study enrolled 452 patients eligible for platinum-doublet chemotherapy with no known EGFR-mutations or ALK gene translocations. Patients were randomized on a 1-to-1 basis to receive either neoadjuvant tislelizumab (200 mg; n = 226) or placebo (n = 227) once every 3 weeks plus chemotherapy for 3 to 4 cycles followed by surgical resection and adjuvant tislelizumab (400 mg) or placebo once every 6 weeks for no more than 8 cycles. The primary end point was EFS by blinded independent central review. Secondary end points included OS and safety.
At a median follow-up of 22 months, median EFS or OS was not reached in either treatment arm. However, there was a statistically significant difference in EFS (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.40 to 0.79; 1-sided P = .003) and an OS benefit trend (HR, 0.62; 95% CI, 0.39 to 0.98; 1-sided P = .0193) which favored tislelizumab. Grade ≥3 treatment-related adverse events were reported by 163 patients in the tislelizumab arm and 150 patients in the placebo arm. Serious treatment-related adverse events were reported by 35 patients in the tislelizumab arm and 18 patients in the placebo arm.
Dr Yue at al concluded, “These data support this combination as a new standard of care for patients with resectable NSCLC.”
Source:
Yue D, Wang W, Liu H, et al. VP1-2024: RATIONALE-315: Event-free survival (EFS) and overall survival (OS) of neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS in resectable non-small cell lung cancer (NSCLC). Ann Oncol. Published online: February 15, 2024. doi: 10.1016/j.annonc.2024.01.005
