newsfilter
← Latest News
Business Wire·

BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA

ONC
  • The FDA has approved TEVIMBRA (tislelizumab) plus ZIIHERA (zanidatamab) and chemotherapy for first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA).
  • This approval represents the first immunotherapy-based regimen to achieve a median overall survival (OS) exceeding two years in this setting, with a median OS of 26.4 months compared to 19.2 months for the control arm.
  • The approval is supported by data from the Phase 3 HERIZON-GEA-01 trial, which showed statistically significant improvements in both overall survival and progression-free survival (PFS) of 12.4 months versus 8.1 months for the control.
  • Clinical benefits were observed consistently across all PD-L1 subgroups, including patients with PD-L1-negative tumors, and across both HER2 IHC 3+ and HER2 IHC 2+ populations.
  • The regimen demonstrated a safety profile consistent with known profiles of its components, with no new safety signals identified.
  • Common adverse reactions (≥20%) included diarrhea, nausea, anemia, decreased appetite, vomiting, decreased neutrophil count, hypokalemia, fatigue, rash, decreased plate count, peripheral neuropathy, infusion-related reactions, and increased aspartate aminotransferase.
  • TEVIMBRA is a PD-1 inhibitor developed by BeOne Medicines, while ZIIHERA is a bispecific HER2-directed antibody developed by Jazz Pharmaceuticals and BeOne.
  • The trial randomized 914 patients across 300 sites in more than 30 countries to compare the new regimen against the standard of care, trastuzumab plus chemotherapy.