SAN CARLOS, Calif., August 25, 2026
BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (HER2+ GEA). The approval represents an important expansion of the company’s oncology portfolio and provides a new immunotherapy-based treatment option for patients with HER2-positive GEA, a disease setting associated with significant unmet medical need. The approval was supported by results from the Phase 3 HERIZON-GEA-01 clinical trial, positioning the TEVIMBRA-based combination as a potentially important first-line treatment approach in HER2-positive GEA.
Phase 3 Data Support BeOne’s FDA Approval
The FDA decision was supported by the HERIZON-GEA-01 Phase 3 trial, a global randomized study evaluating ZIIHERA plus chemotherapy with or without TEVIMBRA against trastuzumab plus chemotherapy. The study enrolled 914 patients across approximately 300 sites in more than 30 countries, evaluating overall survival and progression-free survival as dual primary endpoints. The TEVIMBRA, ZIIHERA and chemotherapy combination demonstrated a median overall survival of 26.4 months, compared with 19.2 months for the control regimen, representing a statistically significant improvement. Median progression-free survival reached 12.4 months versus 8.1 months with the control arm. The results provide the key clinical evidence supporting the regulatory approval and strengthen BeOne’s position in developing combination-based approaches for difficult-to-treat solid tumors.
Benefit Observed Across PD-L1 and HER2 Groups
A notable aspect of the HERIZON-GEA-01 results was the consistency of treatment benefit across important patient subgroups. The TEVIMBRA-based regimen demonstrated improvements in survival outcomes regardless of PD-L1 status, including patients with PD-L1-negative tumors with a TAP score below 1%. In this subgroup, median overall survival reached 29.7 months, compared with 15.8 months in the control arm. Clinical benefit was also observed across HER2 expression levels, including patients with HER2 IHC 3+ and IHC 2+ tumors with ISH positivity. The combination was generally consistent with the known safety profiles of its individual components, with no new safety signals identified. Reported adverse reactions included diarrhea, nausea, anemia, decreased appetite, vomiting, fatigue, rash and peripheral neuropathy, among others.
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TEVIMBRA Expands BeOne’s Solid Tumor Strategy
The FDA approval further establishes TEVIMBRA as a foundational asset within BeOne’s solid tumor portfolio, expanding its application into another important gastrointestinal cancer setting. TEVIMBRA is a humanized PD-1 inhibitor designed with high affinity and binding specificity for PD-1 while minimizing interaction with Fc-gamma receptors on macrophages. BeOne reported that its global TEVIMBRA development program has enrolled nearly 15,000 patients across more than 30 countries and regions, covering numerous clinical trials and registration-enabling studies. The company is now positioned to bring the newly approved combination to U.S. patients with HER2-positive advanced or metastatic GEA, while continuing broader development of TEVIMBRA across multiple tumor types. The approval highlights BeOne’s strategy of combining immune checkpoint inhibition with targeted HER2 therapy and chemotherapy to improve outcomes in challenging oncology indications.
Source:BeOne Medicines,. press relese
