Zanidatamab Improves Survival in Early Stable Disease BTC Patients
The newest data from the HERIZON-BTC-01 trial (NCT04466891) show zanidatamab monotherapy can prolong overall survival (OS) in adult patients who have HER2-positive advanced biliary tract cancer (BTC),1 a important advancement considering the rare cancer is most often fatal with a median OS of less than 13 months from diagnosis. These data from the completed trial were presented at the American Society of clinical Oncology Gastrointestinal Cancers Symposium.
The dual HER-2 targeted bispecific monoclonal antibody received accelerated approval from the FDA in November 2024 for this indication,2 and it has sinc
In addition, by week 25, 7 of 20 patients who had reached SD status by week 9 had progressed to a PR, and there were 36 overall responders, 3 CRs and 33 PRs; of this group, 12 patients had stable disease, and 6 patients experienced progressive disease. Post the 9-week analysis, survival results remained positive and consistent, the authors highlighted, with any responders to zanidatamab exhibiting a median OS of 20 months (95% CI, 13.0-29.3); patients with SD, 8.4 months (95% CI, 0.5-15.2); and patients with progressive disease, 5.4 months (95% CI, 1.8-NE).
Breaking these data down further,the following results were seen:
- Asian patients had the highest rate of CR or PR (69%) but also the highest rate of PD (62%)
- White patients had the highest rate of SD (50%)
- Patients with an ECOG PS of 1 vs 0 had higher rates of CR/PR (77% vs 23%) and SD (57% vs 43%) but also higher PD (54% vs 46%)
- Cases of GBC vs ICC and ECC had the highest rate of CR/PR (63% vs 20% vs 17%,respectively) but also the highest rate of PD (54% vs 15% vs 31%)
- ICC vs GBC and ECC had the highest rate of SD (57% vs 29% vs 14%)
- Patie
- FDA approves zanidatamab-hrii for HER2-biliary tract cancer.
https://www.ajmc.com/view/fda-approves-zanidatamab-hrii-for-her2-biliary-tract-cancer - Zymeworks announces NMPA approval of zanidatamab in China for adults with previously treated, unresectable or metastatic HER2-high expression (IHC3+) biliary tract cancer. News release. Zymeworks. May 30, 2025. Accessed January 9, 2026.
https://clinicaltrials.gov/study/NCT04466891
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