The FDA today approved tislelizumab (Tevimbra; BeIGene) plus chemotherapy for the first line treatment of patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1, according to a press release from BeiGene.1
Results from the phase 3 RATIONALE-306 trial supported the FDA approval of tislelizumab plus chemotherapy in the first line. | Image credit: wladimir1804
Tislelizumab was initially approved in 2024 as a second-line monotherapy for unresectable or metastatic ESCC following systemic chemotherapy, and 3-year results from the phase 3 RATIONALE-306 study (NCT03783442) presented at last year’s American Society of Clinical Oncology Annual Meeting that demonstrated tislelizumab-plus-chemotherapy’s safety and efficacy in the second line.2
Results from the randomized, placebo-controlled, double-blind RATIONALE-306 supported the FDA’s approval of frontline tislelizumab plus chemotherapy.1 The study met its primary end point, showing a statistically significant improvement in overall survival in patients randomized to the tislelizumab combination vs a placebo in combination with chemotherapy.
“The approval of [tislelizumab] in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease,” Nataliya Uboha, MD, PhD, associate professor at the University of Wisconsin, Carbone Cancer Center, said in a statement.1 “There is a critical need for effective treatments of ESCC, and [tislelizumab] has been shown to improve outcomes in this patient population.”
References
1. Tevimbra approved in U.S. for first-line treatment of advanced esophageal squamous cell carcinoma in combination with chemotherapy. News release. BeiGene. March 4, 2025. Accessed March 4, 2025. https://ir.beigene.com/news/tevimbra-approved-in-u-s-for-first-line-treatment-of-advanced-esophageal-squamous-cell-carcinoma-in-combination/8379a7c3-35ce-45af-82d3-164c64ecf37c/
2. Joszt L. Tislelizumab plus chemo meaningfully improves OS, PFS in advanced esophageal cancer. AJMC®. June 14, 2024. Accessed March 4, 2025. https://www.ajmc.com/view/tislelizumab-plus-chemo-meaningfully-improves-os-pfs-in-advanced-esophageal-cancer
