BeOne Medicines has announced that the U.S. Food and Drug Administration has granted Priority Review to its supplemental Biologics License Application (sBLA) for a combination therapy involving Tevimbra, Ziihera and Chemotherapy. The regimen is intended as a first-line treatment for patients with unresectable, locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma, including cancers of the stomach, gastroesophageal junction and esophagus.

In addition, the FDA has granted Breakthrough Therapy Designation to Ziihera in combination with chemotherapy, with and without Tevimbra, underscoring the potential of this regimen to significantly improve outcomes in a disease with limited treatment options.

The regulatory decisions are based on data from the Phase III HERIZON-GEA-01 trial, a global study evaluating the safety and efficacy of Ziihera plus chemotherapy, with or without Tevimbra, compared to standard-of-care trastuzumab-based therapy. The trial, conducted in collaboration with Jazz Pharmaceuticals, enrolled 914 patients across more than 30 countries.

Results from the first interim analysis demonstrated a notable survival benefit. Patients receiving the Tevimbra-containing combination achieved a median overall survival of 26.4 months, compared to 24.4 months for Ziihera plus chemotherapy and 19.2 months for the control group. Progression-free survival also improved significantly, reaching 12.4 months for the Ziihera-based arms versus 8.1 months in the control arm. Importantly, these benefits were observed regardless of PD-L1 status.

Safety findings for the combination therapy were consistent with known profiles of the individual drugs, with no new safety concerns identified.

BeOne Medicines plans to leverage the FDA’s Project Orbis initiative, which enables concurrent regulatory review across multiple countries, to accelerate global access to the therapy. The company aims to bring this treatment to patients more quickly, given the significant unmet need in HER2-positive gastroesophageal cancers.

Gastroesophageal adenocarcinoma remains one of the most challenging cancers to treat, accounting for a significant global disease burden. Around 20 percent of patients exhibit HER2-positive disease, which is associated with poor prognosis and limited long-term survival.

Ziihera is a bispecific HER2-targeted antibody designed to bind two distinct sites on the HER2 receptor, triggering tumour cell death through multiple immune-mediated mechanisms. Tevimbra, on the other hand, is an anti-PD-1 monoclonal antibody that enhances the immune system’s ability to detect and attack cancer cells.

Together, the combination therapy represents a potentially transformative approach in first-line treatment, offering improved survival outcomes and a new standard of care for patients with advanced HER2-positive gastroesophageal cancers.