BRIEF—Mixed results for BeiGene's tislelizumab in G/GEJ adenocarcinoma

Chinese biotech firm BeiGene has announced findings from the Phase III RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

At the interim analysis, tislelizumab in combination with chemotherapy met the primary endpoint of overall survival (OS) in patients with PD-L1 expression, though additional follow-up is needed to assess OS benefits in the intention-to-treat population. The safety profile of tislelizumab was consistent with that observed in previous trials, with no new safety signals identified with the addition of chemotherapy.

Yong Ben, chief medical officer, Solid Tumors at BeiGene, said: “The addition of tislelizumab to chemotherapy significantly extended the OS for previously untreated patients with advanced or metastatic G/GEJ adenocarcinoma whose tumor expressed PD-L1. We will continue to follow up to determine OS benefits across the patient population in the trial.”