Tislelizumab-jsgr Plus Chemotherapy Approved as First-line Option for Esophageal Cancer
The FDA has approved a new combination regimen for certain patients with esophageal cell squamous cell carcinoma.
The U.S. Food and Drug Administration (FDA) has approved tislelizumab-jsgr (Tevimbra) in combination with chemotherapy for the treatment of patients with untreated PD-L1-positive esophageal squamous cell carcinoma (ESCC) that is unresectable or metastatic.
Tislelizumab-jsgr is an immune checkpoint inhibitor, a type of immunotherapy that promotes an antitumor immune response by binding the PD-1 immune checkpoint protein on certain immune cells. This helps keep the antitumor response active. Tislelizumab is one of four immune checkpoint inhibitors approved for esophageal cancer. In 2024, tislelizumab-jsgr was approved as monotherapy for patients with advanced ESCC previously treated with chemotherapy but not immunotherapy. The latest approval makes tislelizumab-jsgr available to certain patients with ESCC who have not yet received treatment.
This approval was based on results from the randomized, double-blind, placebo-controlled, international phase III RATIONALE-306 trial. In this trial, patients with unresectable, locally advanced, recurrent, or metastatic ESCC were randomly assigned (1:1) to receive chemotherapy with either placebo or tislelizumab-jsgr.
After three years, patients with PD-L1-positive tumors who were in the tislelizumab-jsgr arm were 34% less likely to have died than those in the placebo arm, with half of the patients living at least 16.8 months compared with at least 9.6 months in the placebo arm.
The recommended dose for tislelizumab is 200 mg every three weeks until disease progression or unacceptable toxicity. The recommended chemotherapy dose varies based on the specific chemotherapy agent used.
ESCC is a type of esophageal cancer that forms in the thin, flat cells that line the esophagus. According to federal statistics, it was estimated that 22,070 individuals would be diagnosed with esophageal cancer and 16,250 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on March 4, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.