BeOne wins FDA approval for TEVIMBRA GEA treatment

• BeOne Medicines (NASDAQ:ONC) received FDA approval for TEVIMBRA combined with ZIIHERA and chemotherapy for HER2-positive gastroesophageal adenocarcinoma.
• Phase 3 HERIZON-GEA-01 data showed median overall survival of 26.4 months compared with 19.2 months for the control arm.
• The approval expands TEVIMBRA’s use in first-line treatment of advanced HER2-positive gastric, gastroesophageal junction, and esophageal adenocarcinoma.

BeOne Medicines (NASDAQ:ONC) received U.S. FDA approval for TEVIMBRA (tislelizumab) combined with ZIIHERA (zanidatamab) and chemotherapy as a first-line treatment for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.

The approval is based on results from the Phase 3 HERIZON-GEA-01 trial, which evaluated the combination against trastuzumab plus chemotherapy in patients with advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.

In the trial, TEVIMBRA plus ZIIHERA and chemotherapy produced median overall survival of 26.4 months compared with 19.2 months in the control arm, while median progression-free survival reached 12.4 months compared with 8.1 months.

The company reported that improvements in overall survival and progression-free survival were observed across patient subgroups, including patients with PD-L1-negative tumors, while the safety profile was consistent with the known profiles of the treatment components.

BeOne Medicines stated that TEVIMBRA is its first approved solid tumor portfolio asset and that the company continues to evaluate combination treatments across cancer types.

The approval adds another treatment option for HER2-positive gastroesophageal adenocarcinoma, a disease affecting cancers of the stomach, gastroesophageal junction, and esophagus.