A New Immunotherapy for Esophageal Cancer
Tislelizumab-jsgr received its first FDA approval to treat certain esophageal cancers.
The U.S. Food and Drug Administration (FDA) has approved tislelizumab-jsgr (Tevimbra) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior chemotherapy but have not received a PD-1 or PD-L1 inhibitor.
Tislelizumab-jsgr is a type of immunotherapy that promotes an antitumor immune response by binding the immune-suppressing PD-1 protein on certain immune cells; this prevents PD-1 from inhibiting the cell’s activity, thereby keeping the antitumor immune response active.
This is the first FDA approval for tislelizumab.
The approval was based on results from RATIONALE 302, a randomized, controlled, open-label, global, phase III clinical trial enrolling 512 patients with advanced or metastatic ESCC that had progressed during or after first-line systemic treatment. Patients were randomly assigned (1:1) to receive either tislelizumab-jsgr or chemotherapy (investigator’s choice of paclitaxel, docetaxel, or irinotecan).
Patients treated with tislelizumab-jsgr had a significantly longer median overall survival than those treated with chemotherapy (8.6 months vs. 6.3 months, respectively). After 12 months, 37.4% of patients in the tislelizumab-jsgr arm were alive, compared with 23.7% of patients in the chemotherapy arm.
The recommended dosage for tislelizumab-jsgr is 200 mg delivered intravenously once every three weeks.
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 22,370 individuals would be diagnosed with esophageal cancer and 16,130 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on March 14, 2024.
