Tislelizumab was given to the tislelizumab group on day one and then every 21 days; the chemotherapy group received a combination of drugs: paclitaxel on day one and then every 21 days or on a weekly schedule, docetaxel on day one and then every 21 days, and irinotecan on days one and eight and then every 21 days. The study’s primary endpoint was overall survival in all randomized patients. Patients in both groups were treated with these protocols until their disease progressed, they showed unacceptable toxicity levels of any of the drugs, or they withdrew from the study.
Results showed that tislelizumab clinically and significantly improved overall survival compared to chemotherapy in the intent-to-treat population (8.6 vs 6.3 months). Tislelizumab also showed significant improvement in overall survival compared to chemotherapy in patients with a vCPS of ≥10% (10.3 vs 6.8 months), as well as a higher overall response rate (20.3% vs 9.8%) and a more durable response (7.1 vs 4.0 months)