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-312 trial evaluated time to disease progression in the brain and quality-adjusted time without symptoms or toxicity (Q-TWiST) in patients with brain progressive disease (PD) with first-line extensive-stage small cell lung cancer treated with tislelizumab (TIS) plus chemotherapy (CT) or placebo (PBO) plus CT. Among 457 patients (TIS+CT, n=227; PBO+CT, n=230) with a median follow-up of 14.2 months, brain PD was assessed as time to PD in the brain per RECIST v1.1 or radiation therapy (RT) to the brain during treatment. One patient (<1%) in the TIS+CT arm and 4 (2%) in the PBO+CT arm had brain metastases at baseline. 44 patients (19%) in each arm had brain PD during the trial; 41 (18%) in TIS+CT and 34 (15%) in PBO+CT received brain RT; 3 (1%) and 1 (<1%), respectively, received prophylactic cranial irradiation. Among patients with brain PD, median progression-free survival was 5.4 months (95% CI, 4.3–5.6) with TIS+CT versus 4.4 months (95% CI, 4.2–5.7) with PBO+CT, and median overall survival was 15.5 months (95% CI, 12.3–23.5) versus 13.6 months (95% CI, 10.6–17.0), respectively. Q-TWiST showed a 28.8% improvement and an absolute gain of 4.7 months (P<0.05) for TIS+CT.

ClinicalTrials.gov ID: NCT04005716