SignalFDA/Bio
2026 ESMO LBA | Innovent Announces International Phase 3 Study of Arcotatug Tavatecan (CLDN18.2-ADC) in Gastric Cancer Met Dual Primary Endpoints of PFS and OS
Phase 3 CLDN18.2-ADC gastric cancer study met dual PFS and OS endpoints.
Context
What happened: Innovent announced positive topline results from the Phase 3 G-HOPE-001 study of arcotatug tavatecan (CLDN18.2-ADC) in previously treated, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, presented as a Late-Breaking Abstract at the 2026 ESMO Congress.
Key numbers: Median OS 10.2 vs 6.9 months
Why it matters: The study met both primary endpoints with statistically significant and clinically meaningful OS and PFS benefits. Innovent states arcotatug tavatecan is the first CLDN18.2-ADC to have a New Drug Application accepted for regulatory review globally.
Market: +2.1% today ($83.35), +5.8% YTD, 1.3x vol — as of 07:45 UTC
What changed
Innovent announced positive topline results from the Phase 3 G-HOPE-001 study of arcotatug tavatecan (CLDN18.2-ADC) in previously treated, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, presented as a Late-Breaking Abstract at the 2026 ESMO Congress.
Why it matters
The study met both primary endpoints with statistically significant and clinically meaningful OS and PFS benefits. Innovent states arcotatug tavatecan is the first CLDN18.2-ADC to have a New Drug Application accepted for regulatory review globally.
Market: +2.1% today ($83.35), +5.8% YTD, 1.3x vol — as of 07:45 UTC