Cancer, Gastroesophageal adenocarcinomas, Cholangiocarcinoma
ZYMEZymeworksCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Zanidatamab (HER2) + chemotherapy + tislelizumab in Cancer, Gastroesophageal adenocarcinomas, Cholangiocarcinoma. The expected timing is based on the latest available company guidance and may change.
Prelim results presented at ASCO 2022. 1/19/23- Reported tolerability and efficacy data from Ph2 at ASCO GI 2023. 8/7/25- No recent Q2'25 report update. 11/06/25:- Partner Jazz plans Phase 3 1L GEA top-line PFS data from zanidatamab in Q4 2025. 01/06/26:- Ph3 HERIZON-GEA-01 showed positive PFS/OS in 1L HER2+ GEA; next OS interim expected Mid-2026. 01/12/26:- Late-breaking HERIZON-GEA-01 ASCO GI data detailed PFS and OS benefits; next OS interim remains expected Mid-2026. 03/02/26:- HERIZON-GEA-01 supports Ziihera; sBLA Q1 2026, OS interim and potential U.S. launch expected Mid- and 2H 2026. 05/07/26:- US sBLA priority review; PDUFA Aug 25, 2026; China sBLA accepted; second OS interim expected Mid-2026. 08/06/26:- HERIZON-GEA-01 OS readout expected Q3 2026; PDUFA remains Aug 25, 2026.
Verification
Confirm timing and program details against the company announcement or filing.