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A phase 3 trial just delivered a big win for patients with a tough-to-treat stomach cancer. Arcotatug tavatecan, a novel antibody-drug conjugate targeting CLDN18.2, significantly improved both progression-free and overall survival compared to standard chemotherapy in previously treated advanced gastric or gastroesophageal junction cancer. Regulatory filings in Japan and China are already in motion.
A phase 3 trial just delivered a big win for patients with a tough-to-treat stomach cancer. The G-HOPE-001 trial showed that arcotatug tavatecan (IBI343/TAK-921) — a novel antibody-drug conjugate (ADC) targeting the protein CLDN18.2 — significantly outperformed physician's choice chemotherapy in patients with previously treated, CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Results were presented at the 2026 ESMO Congress.
The drug met both primary endpoints, cutting the risk of disease progression and death meaningfully compared to standard options like irinotecan or paclitaxel. The safety profile was also favorable — grade 3+ side effects were slightly less common with arcotatug tavatecan, and diarrhea occurred far less frequently than with chemotherapy.
By the Numbers:
Why it matters: Advanced gastric cancer has very limited third-line treatment options, and outcomes are typically poor. This trial positions arcotatug tavatecan as a meaningful new option for a biomarker-selected population, with regulatory filings already underway in Japan and China.
