Tislelizumab and Chemotherapy Approved as First-line Option for Stomach and Gastroesophageal Junction Cancers
The FDA has approved tislelizumab plus chemotherapy for certain patients with gastric or gastroesophageal junction adenocarcinoma.
The U.S. Food and Drug Administration (FDA) has approved tislelizumab-jsgr (Tevimbra) in combination with chemotherapy for the treatment of patients with previously untreated, PD-L1-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma that is unresectable or metastatic and does not express human epidermal growth factor receptor 2 (HER2).
Tislelizumab-jsgr is a type of immunotherapy that binds to the PD-1 immune checkpoint protein on certain immune cells to prevent immune suppression and keep the antitumor immune response active. Tislelizumab received prior approval in patients with advanced esophageal cancer that was previously treated.
The latest approval was based on results from the randomized, double-blind, placebo-controlled, multicenter phase III RATIONALE-305 global trial. In this trial, 997 patients with locally advanced or metastatic gastric or GEJ adenocarcinoma were randomly assigned (1:1) to receive either tislelizumab-jsgr and chemotherapy or placebo and chemotherapy.
Patients in the tislelizumab-jsgr arm were 20% less likely to die than those in the placebo arm, with half of tislelizumab-treated patients living at least 15 months compared with 12.9 months in the chemotherapy-only arm.
The recommended dose for tislelizumab-jsgr is 150 mg every two weeks, 200 mg every three weeks, 300 mg every four weeks, or 400 mg every six weeks until disease progression or unacceptable toxicity.
Gastric cancer (also called stomach cancer) and GEJ cancer are both cancers of the digestive tract. Gastric cancer affects the lining of the stomach, and GEJ cancer affects the area where the stomach and esophagus meet. According to federal statistics, it was estimated that 30,300 individuals would be diagnosed with stomach cancer and 10,780 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on December 27, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.