BeOne Medicines Reports Promising Phase 3 HERIZON-GEA Results at ASCO 2026
BeOne Medicines Announces Phase 3 HERIZON-GEA Data Published in NEJM and Presented at ASCO 2026
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BeOne Medicines has announced significant findings from the Phase 3 HERIZON-GEA-01 trial, demonstrating that the combination of ZIIHERA and TEVIMBRA with chemotherapy improves overall survival in patients with HER2-positive gastroesophageal adenocarcinoma. The results, published in NEJM and presented at ASCO 2026, indicate a median overall survival of 26.4 months.
- 01The HERIZON-GEA-01 trial showed a median overall survival of 26.4 months with ZIIHERA and TEVIMBRA compared to 19.2 months with the control.
- 02Progression-free survival improved significantly, with a median of 12.4 months for ZIIHERA-containing regimens.
- 03The combination therapy was effective even in patients with PD-L1 <1%, showcasing its broad applicability.
- 04Safety profiles were consistent with existing HER2 therapies, with diarrhea being the most common severe adverse event.
- 05Regulatory applications for TEVIMBRA and ZIIHERA have been accepted for priority review by the FDA and other authorities.
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BeOne Medicines has reported promising results from its Phase 3 HERIZON-GEA-01 trial, which evaluated the efficacy of ZIIHERA (zanidatamab) combined with TEVIMBRA (tislelizumab) and chemotherapy for treating advanced HER2-positive gastroesophageal adenocarcinoma (GEA). The trial, involving 914 patients across over 30 countries, demonstrated a statistically significant overall survival (OS) benefit, with a median OS of 26.4 months for the combination therapy, compared to 19.2 months for the control group receiving trastuzumab plus chemotherapy. Additionally, the trial reported a median progression-free survival (PFS) of 12.4 months for the ZIIHERA-containing arms. Notably, the treatment showed benefits irrespective of PD-L1 status, including in patients with PD-L1 <1%. The findings were published in The New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2026. BeOne is pursuing regulatory approval for these therapies in various markets, including the U.S. and China.
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The results from the HERIZON-GEA-01 trial could lead to a new standard of care for patients with HER2-positive gastroesophageal adenocarcinoma, significantly improving treatment outcomes.
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