Onco-Summaries: Daily Oncology Updates at a Glance

25/08/2026

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• US FDA approves zanidatamab combination therapy in HER2+ GEA

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US FDA approves zanidatamab combination therapy in HER2+ GEA (Ref)

The US FDA has approved Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) with and without BeOne's tislelizumab (anti-PD-1) + chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status

Approval was supported by Phase 3 HERIZON-GEA-01 trial, showing median overall survival exceeding two years (Ref)

• Progression-Free Survival (PFS)

  • Zanidatamab + tislelizumab + chemotherapy: 12.4 months (HR for progression/death vs trastuzumab + chemo: 0.63; 95% CI, 0.51–0.78; P<0.001)

  
  

  • Zanidatamab + chemotherapy: 12.4 months (HR for progression/death vs trastuzumab + chemo: 0.65; 95% CI, 0.52–0.81; P<0.001)

  
  

  • Trastuzumab + chemotherapy: 8.1 months

• Overall Survival (OS)

  
  

  • Zanidatamab + tislelizumab + chemotherapy: 26.4 months vs trastuzumab + chemo: 19.2 months (HR for death: 0.72; 95% CI, 0.57–0.90; P=0.004)

  
  

  • Zanidatamab + chemotherapy: 24.4 months vs trastuzumab + chemo: 19.2 months (HR: 0.80; 95% CI, 0.64–1.01; P=0.06; not statistically significant at interim analysis)

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