BeiGene, Ltd.  a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA^® (tislelizumab-jsgr), 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 PD-L1.

“The approval of TEVIMBRA in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease,” said Dr. Nataliya Uboha, Associate Professor, University of Wisconsin, Carbone Cancer Center. “There is a critical need for effective treatments of ESCC, and TEVIMBRA has been shown to improve outcomes in this patient population.”

The additional indication is based on results from BeiGene’s RATIONALE-306 (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of TEVIMBRA in combination with platinum-containing chemotherapy as a first-line treatment in adult patients (n=649) with unresectable, locally advanced recurrent or metastatic ESCC. The study met its primary endpoint and demonstrated a statistically significant improvement in overall survival (OS) for adult patients randomized to TEVIMBRA in combination with chemotherapy compared to placebo in combination with chemotherapy. Exploratory analyses indicated that the improvement in the intent-to-treat (ITT) 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 TEVIMBRA plus chemotherapy compared to 9.6 months for patients treated with placebo plus chemotherapy (HR: 0.66, [95% CI: 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,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “FDA approval of TEVIMBRA 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.”

The safety of TEVIMBRA in combination with chemotherapy was evaluated in the same global clinical trial, RATIONALE-306. The most frequent serious adverse reactions (≥2%) were pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis. The most common (≥20%) adverse reactions were anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis.

TEVIMBRA is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction (G/GEJ) cancers.

The Company recently announced its intent to change its name to BeOne Medicines Ltd., reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.