FDA Approval of Tislelizumab

The panelists discuss how the RATIONALE-306 trial demonstrated efficacy outcomes through its design, measuring both progression-free survival and overall survival as key end points.

Panelists discuss how RATIONALE-305 trial data shows promising updated overall survival benefits for patients receiving tislelizumab plus chemotherapy compared to placebo plus chemotherapy in advanced gastric or gastroesophageal junction adenocarcinoma.

Panelists discuss how the RATIONALE-305 trial revealed a manageable adverse event profile for tislelizumab plus chemotherapy despite increased rates of neutropenia and anemia compared to placebo plus chemotherapy in advanced gastric cancer patients.

Panelists discuss how the optimal sequencing between available therapies for advanced gastric cancer remains challenging but should be guided by patient-specific factors, prior treatment response, and molecular characteristics of the tumor.

Panelists discuss how RATIONALE-305 represents a significant advancement in first-line treatment for advanced gastric cancer with tislelizumab demonstrating meaningful survival benefits while maintaining a tolerable safety profile that could potentially reshape standard clinical practice.