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IBI343 Meets PFS and OS Endpoints in Phase 3 G-HOPE-001 Gastric Cancer Trial

3 reports1 sourceupdated 6 hours ago

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At the 2026 ESMO congress, Innovent announced in a late-breaking abstract that the international multicenter phase 3 G-HOPE-001 study of arcotatug tavatecan (IBI343), a CLDN18.2-directed antibody-drug conjugate, met both dual primary endpoints of progression-free survival and overall survival in later-line CLDN18.2-positive gastric cancer. The interim analysis showed median PFS of 7.1 versus 3.1 months (HR 0.45, 95% CI 0.35-0.58) and median OS of 10.2 versus 6.9 months (HR 0.57, 95% CI 0.45-0.73). Confirmed objective response rate was 37.4% versus 7.7% in the control arm. Full results beyond the interim analysis and regulatory steps have not yet been reported.

Written by a model from the reports · updated 3 hours ago

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Oct 24
  1. mp.weixin.qq.com
    Takeda and Innovent CLDN18.2 ADC arcotatug tavatecan Phase 3 G-HOPE-001 Meets Dual PFS and OS Primary Endpoints

    Takeda and Innovent Biologics announced results from the international Phase 3 G-HOPE-001 study of the CLDN18.2-targeted ADC arcotatug tavatecan. The study met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in previously multiply treated patients with CLDN18.2-positive advanced gastric cancer, significantly extending survival.

Oct 23
  1. mp.weixin.qq.comPick
    ESMO G-HOPE-001 Interim Analysis: Arcotatug Tavatecan Median PFS 7.1 Months in Later-Line CLDN18.2-Positive Gastric Cancer

    The ESMO 2026 LBA77 interim analysis of the phase 3 G-HOPE-001 trial in later-line CLDN18.2-positive gastric cancer showed arcotatug tavatecan met both co-primary endpoints of PFS and OS. At IA2, median PFS was 7.1 vs 3.1 months, HR 0.45 (95% CI 0.35-0.58); median OS was 10.2 vs 6.9 months, HR 0.57 (95% CI 0.45-0.73); confirmed ORR was 37.4% vs 7.7%.

  2. mp.weixin.qq.com
    Innovent Announces at 2026 ESMO LBA That IBI343 Met PFS and OS Dual Primary Endpoints in Phase 3 G-HOPE-001 Gastric Cancer Study

    At the 2026 ESMO congress, Innovent announced in a late-breaking abstract that the international multicenter phase 3 G-HOPE-001 study of the CLDN18.2 ADC IBI343 in gastric cancer met both primary endpoints of progression-free survival and overall survival.

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CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org