The tislelizumab combination met the primary endpoint of OS in patients with programmed death ligand 1 (PD-L1) expression, with additional follow-up needed to assess OS benefits in the intention-to-treat population.
Tislelizumab (BeiGene) in combination with chemotherapy showed positive results versus placebo as a first-line treatment for patients with locally advanced, unresectable, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, according to findings from the global phase 3 RATIONALE 305 trial.
RATIONALE 305 is a randomized, placebo-controlled phase 3 trial comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy and placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with locally advanced, unresectable, or metastatic G/GEJ adenocarcinoma.
The primary endpoint of the trial was overall survival (OS), and the secondary endpoints included progression-free survival, overall response rate, duration of response, and safety. In total, 997 patients from 13 countries and regions were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.
The tislelizumab combination met the primary endpoint of OS in patients with programmed death ligand 1 (PD-L1) expression, with additional follow-up needed to assess OS benefits in the intention-to-treat population. The safety profile of tislelizumab was consistent with what was observed in previous trials with no safety signals identified with the addition of chemotherapy, according to the study authors.
“The addition of tislelizumab to chemotherapy significantly extended the overall survival for previously untreated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumor expressed PD-L1. We will continue to follow up to determine OS benefits across the patient population in the trial,” said Yong Ben, MD, chief medical officer of Solid Tumors at BeiGene, in the press release.
BeiGene announces positive findings from phase 3 trial of tislelizumab in combination with chemotherapy in first-line gastric or gastroesophageal junction cancer. BusinessWire. January 24, 2022. Accessed January 26, 2022. https://www.businesswire.com/news/home/20220124005223/en