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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, March 8, 2024
The neoadjuvant combination of the checkpoint inhibitor tislelizumab plus chemotherapy with adjuvant tislelizumab may prove to be a viable new standard of care for patients with resectable non–small cell lung cancer (NSCLC), according to interim results of the phase III RATIONALE-315 clinical trial presented at the February 2024 European Society for Medical Oncology (ESMO) Virtual Plenary (Abstract VP1-2024). Dongsheng Yue, MD, of Tianjin Medical University Cancer Institute and Hospital, China, and colleagues reported a clinically meaningful and statistically significant improvement in event-free survival and an overall survival benefit trend for the treatment regimen, compared with placebo plus chemotherapy. They also noted the safety of the regimen was consistent with known treatment risks.
A total of 453 patients with treatment-naive resectable stage II to IIIA NSCLC eligible for platinum-doublet chemotherapy with no known EGFR mutations or ALK gene translocations were enrolled in the study. Patients were randomly assigned to receive either three to four cycles of neoadjuvant tislelizumab (200 mg) plus chemotherapy or chemotherapy alone. Following surgery, those who received the combination then received up to eight cycles of adjuvant tislelizumab (400 mg), whereas the control group received a placebo.
At a median follow-up of 22 months, the investigators reported that median event-free survival (a primary study endpoint) and overall survival were not reached for either group. However, they observed a statistically significant difference in event-free survival (hazard ratio [HR] = 0.56; 95% confidence interval [CI] = 0.40–0.79; one-sided P = .0003) and an overall survival benefit trend (HR = 0.62; 95% CI = 0.39–0.98; one-sided P = .0193) among the patients who received the experimental regimen. They also reported that among those patients, 99.1% experienced grade ≥ 1 treatment-related adverse events, 72.1% experienced grade ≥ 3 treatment-related adverse events, and 15.5% experienced serious treatment-related adverse events vs 99.6%, 66.4%, and 8.0% in the control group, respectively.
Disclosure: For full disclosures of the study authors, visit annalsofoncology.org.
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