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Positive Phase 3 Results Support ZIIHERA® as HER2-Targeted Therapy-of-Choice and Combination with TEVIMBRA® and Chemotherapy as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma
ZIIHERA plus TEVIMBRA and chemotherapy demonstrated clinically meaningful and statistically significant improvements in PFS and OS versus trastuzumab and
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"\nZIIHERA plus TEVIMBRA and chemotherapy demonstrated clinically meaningful and statistically significant improvements in PFS and OS versus trastuzumab and chemotherapy\n\n\nZIIHERA plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first interim analysis\n\n\nFirst Phase 3 trial in 15 years to demonstrate a clinical benefit in this patient population with a novel HER2-targeted therapy\n\n\n SAN CARLOS, Calif.--(BUSINESS WIRE)--\nBeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with or without PD-1 inhibitor TEVIMBRA® (tislelizumab), as first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus.\n\n\nBoth ZIIHERA plus TEVIMBRA and chemotherapy and ZIIHERA plus chemotherapy demonstrated clinically meaningful and highly statistically significant improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy.\n\n\nZIIHERA plus TEVIMBRA and chemotherapy also demonstrated clinically meaningful and statistically significant improvements in overall survival (OS), and ZIIHERA plus chemotherapy demonstrated a clinically meaningful effect with a strong trend toward statistical significance for OS compared to the control arm at the time of this first analysis. The trial is ongoing with an additional planned OS interim analysis for ZIIHERA plus chemotherapy currently expected in mid-2026.\n\n\nThese PFS and OS benefits were observed in the ZIIHERA plus TEVIMBRA and chemotherapy arm versus the control arm in both PD-L1 positive and PD-L1 negative subgroups. Supportive of the primary efficacy endpoints, both combination arms demonstrated improvements in the key secondary endpoints of objective response rate (ORR) and duration of response (DOR) versus the control arm.\n\n\n“Gastric, gastroesophageal junction, and esophageal adenocarcinoma remain major global health c...