FDA Approval of Tislelizumab: RATIONALE-305 Findings and Implications for Practice

Samuel Cytryn, MD, of Memorial Sloan Kettering Cancer Center, discusses the December 2024 FDA approval of tislelizumab in combination with chemotherapy for patients with PD-L1 positive advanced metastatic gastric and gastroesophageal junction cancers. Dr. Cytryn examines key findings from the RATIONALE-305 trial, which demonstrated improved overall and progression-free survival, reinforcing the role of PD-1 inhibitors in this population. The discussion compares tislelizumab’s outcomes to those of nivolumab (from the CheckMate-649 trial) and pembrolizumab (from Keynote-859), emphasizing its safety profile and its potential as an additional therapeutic option.