DISCLAIMER

The contents of the presentation are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and/or efficacy for such investigational products or uses may be made.

SUMMARY

This exploratory analysis of the RATIONALE-315 trial evaluated event-free survival (EFS) and safety according to completion of fewer than 8 versus 8 cycles of adjuvant (adj) tislelizumab (TIS) versus adj placebo in patients with untreated stage II-IIIA non-small cell lung cancer. As of 7 March 2025, 168 patients received adj TIS and 147 patients received adj placebo. In patients with <8/8 cycles, respectively, 95.6/89.7% were male, 61.5/61.2% former smokers, 49.5/42.0% PD-L1 tumor proportion score <1%, 38.5/42.0% stage II, and 61.5/56.7% stage IIIA. At a median follow-up of 41.5 (range, 10.0-56.3) months, 3-year EFS rates with adj TIS were 36.3% (95% CI, 22.4–50.4; n=53) among patients completing <8 cycles (n=91) and 86.0% (95% CI, 78.1–91.2; n=115) among those completing 8 cycles (n=224), compared with 3.5% (95% CI, 0.3–15.2; n=38) and 72.5% (95% CI, 62.9–80.1; n=109), respectively, in the adj placebo group. Grade ≥3 treatment-related adverse events occurred in 11.3% and 6.1% of patients receiving <8 and 8 cycles of adj TIS, respectively; serious treatment-related adverse events occurred in 11.3% and 4.3%, and treatment-related adverse events leading to discontinuation occurred in 17.0% and 0%, respectively.

ClinicalTrials.gov ID: NCT04379635