Officials with the FDA have approved tislelizumab-jsgr (Tevimbra; BeOne Medicines, Ltd, formerly known as BeiGene, Ltd), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death-ligand 1 (PD-L1) (≥1).
The additional indication is based on results from RATIONALE-306 (NCT03783442), a placebo-controlled, double-blind, global phase 3 study that randomly assigned 649 patients with unresectable, locally advanced recurrent or metastatic ESCC to a combination of tislelizumab-jsgr and platinum-containing chemotherapy or placebo.
The study met its primary end point and demonstrated a statistically significant improvement in overall survival (OS) for adult patients in the tislelizumab-jsgr group compared with placebo in combination with chemotherapy. Exploratory analyses indicated that the improvement in the intent-to-treat population was primarily attributed to the results observed in the subgroup of patients with PD-L1 ≥1.
Analysis of OS in the PD-L1–positive (≥1) population (n=481) showed a median OS of 16.8 months for patients treated with tislelizumab-jsgr plus chemotherapy compared with 9.6 months for patients treated with placebo plus chemotherapy (hazard ratio, 0.66 [95% confidence interval, 0.53-0.82]), resulting in a 34% reduction in the risk of death. These results represent an unprecedented improvement in OS in first-line ESCC patients.
“Today’s approval, our third from the FDA in less than a year, reflects our dedication to advancing innovative therapies and addressing critical needs in cancer care,” Mark Lanasa, MD, PhD, Chief Medical Officer, Solid Tumors at BeOne, said in a press release.1 “FDA approval of [tislelizumab-jsgr] for the first-line treatment of advanced esophageal squamous cell carcinoma marks a significant step forward in tackling the unmet needs in this challenging disease area. We are grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible.”
Tislelizumab-jsgr is also approved as monotherapy for the treatment of adult patients with unresectable or metastatic ESCC after previous systemic chemotherapy that did not include a PD-L1 inhibitor and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers.
Company officials recently announced their intent to change the company’s name from BeiGene to BeOne Medicines Ltd, stating the change is their way of reaffirming a commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
Reference
- BeOne Medicines. Tevimbra Approved in U.S. for first-line treatment of advanced esophageal squamous cell carcinoma in combination with chemotherapy [press release]. March 4, 2025. Accessed May 8, 2025. https://ir.beigene.com/news/tevimbra-approved-in-us-for-first-line-treatment-of-advanced-esophageal-squamous-cell-carcinoma-in-combination/8379a7c3-35ce-45af-82d3-164c64ecf37c