FDA grants Priority Review to tislelizumab plus zanidatamab and chemotherapy for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, supported by Phase 3 HERIZON-GEA-01 survival data.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has granted Priority Review to a supplemental biologics license application for a first-line combination regimen of tislelizumab (TEVIMBRA), zanidatamab (ZIIHERA), and chemotherapy in patients with unresectable, locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
The agency also granted Breakthrough Therapy Designation to zanidatamab combined with chemotherapy, with or without tislelizumab, for this indication.
The submission is supported by interim results from the global Phase 3 HERIZON-GEA-01 trial (NCT05152147), which compared zanidatamab plus chemotherapy, with or without tislelizumab, against trastuzumab plus chemotherapy in previously untreated HER2-positive advanced or metastatic GEA.
At the first interim analysis, the addition of tislelizumab to zanidatamab and chemotherapy demonstrated a median overall survival of 26.4 months, compared with 24.4 months for zanidatamab plus chemotherapy and 19.2 months for the control arm. Progression-free survival was 12.4 months in both zanidatamab-containing arms versus 8.1 months in the control group, with benefits observed regardless of PD-L1 status.
The safety profile was consistent with known effects of the individual agents, and no new safety signals were identified.
According to Mark Lanasa, Chief Medical Officer for Solid Tumors at BeOne Medicines, the trial results indicate the potential for the regimen to change the treatment approach in this disease, citing the survival outcomes and the need for improved first-line options.
The company plans to pursue additional regulatory submissions through the FDA’s Project Orbis initiative to support concurrent international review and accelerate patient access.
HERIZON-GEA-01 enrolled 914 patients across more than 30 countries with unresectable, recurrent, or metastatic HER2-positive GEA, defined by HER2 overexpression confirmed through centralized testing.
Patients were randomized to receive zanidatamab plus chemotherapy with or without tislelizumab, or trastuzumab plus chemotherapy, with overall survival and progression-free survival as dual primary endpoints.
Gastroesophageal adenocarcinoma remains a high-burden disease globally, with HER2-positive tumors accounting for about 20% of cases and overall survival rates remaining low, highlighting the need for more effective therapies.
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About the Writer
Dr.Preethi Putti, PharmD is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.