Newly reported results
HERIZON-GEA-01 — zanidatamab ± tislelizumab + chemo (HER2+ GEA)
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma
- Phase
- Phase III
- Recruitment
- Active, not recruiting
- Results maturity
- Primary analysis
- Publication
- Peer-reviewed
- Regulatory approval
- Approval pending (results published)
- NCT
- NCT05152147
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? A targeted drug delayed progression versus standard trastuzumab-based therapy in HER2-positive gastric or esophageal cancer. Approval timelines differ by country.
Why promising? In first-line HER2+ GEA, zanidatamab + chemo (± tislelizumab) prolonged progression-free survival versus trastuzumab + chemo.
What is not proven? Country approval/reimbursement; do not confuse with biliary HERIZON-BTC; OS for zanidatamab+chemo not yet significant at interim (HR 0.80).
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
HERIZON-GEA-01 (NEJM 2026): PFS 12.4 mo (zanidatamab±tislelizumab) vs 8.1 mo (trastuzumab+chemo); HR 0.63 / 0.65. Triplet OS 26.4 vs 19.2 mo (HR 0.72). Zanidatamab+chemo OS not yet significant at interim. Distinct from DESTINY-Gastric04.
Cancer / population: Gastric / esophageal — Tedavi almamış HER2+ ileri gastroözofageal adenokarsinom
Intervention: Zanidatamab + kemoterapi ± tislelizumab
Primary endpoint: PFS ve OS (çift primer)
Source-verified summary: PFS 12,4 vs 8,1 ay (her iki zanidatamab kolu). Triplet OS 26,4 vs 19,2 ay. Regülatör onay bu kartta yok sayılır.
Limitations: İshal / grade ≥3 AE yükü; trastuzumab/T-DXd bağlamından ayrı; onay bekleniyor.