SAN CARLOS, CALIF. -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

“HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients.”

Data supporting sBLA filing

The sBLA submission is based on the first interim analysis (IA1) of HERIZON-GEA-01, a global Phase 3 clinical trial designed to evaluate ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ GEA. Key findings of the trial include:

· Overall survival (OS): The arm in which TEVIMBRA was added to ZIIHERA and chemotherapy resulted in a statistically significant improvement in OS (median OS of 26.4 months) at IA1. The ZIIHERA plus chemotherapy arm achieved a median OS of 24.4 months and the control arm resulted in a median OS of 19.2 months.
· Progression-free survival (PFS): Both ZIIHERA-containing arms delivered a statistically significant and clinically meaningful improvement in median PFS of 12.4 months compared with 8.1 months in the control arm.
· Improvement in OS and PFS was observed regardless of PD-L1 status.
· The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of the components of the combination regimen, and no new safety signals were identified.

Project Orbis pathway

BeOne plans to participate in the FDA’s Project Orbis, an initiative that provides a framework for collaborative review of oncology products among international partners, for the submission of the HERIZON-GEA-01 data in territories in which BeOne holds the ZIIHERA license. With this pathway, BeOne aims to accelerate approval and patient access to this treatment, recognizing the global significance of the HERIZON‑GEA‑01 results, which demonstrated meaningful survival improvements in a disease where outcomes have remained largely unchanged for more than a decade.