Onco-Summaries: Daily Oncology Updates at a Glance

16/06/2026

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• US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer

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US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer (Ref)

ABL Bio & NovaBridge's givastomig, a CLDN18.2 x 4-1BB bispecific antibody, received Fast Track status in combination with nivolumab and chemotherapy for first-line HER2-negative advanced/metastatic gastroesophageal adenocarcinomas that are CLDN18.2 and PD-L1 positive

Clinical Data: Phase 1b results showed strong efficacy, deep and durable responses, and favorable tolerability compared to historical benchmarks for standard of care

Upcoming milestones

• Registrational Phase 3 trial is expected to begin in Q4 2026

  
  

• Detailed Phase 1b data will be presented at a major medical conference in H2 2026

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