Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• In the HERIZON-BTC-01 trial, zanidatamab demonstrated a confirmed Objective Response Rate (ORR) of 41.3% (95% confidence interval (CI): 30.4–52.8) in Cohort 1, which included 80 patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive (Immunohistochemistry [IHC] 2+ or 3+) biliary tract cancer, with 33 of these patients achieving a confirmed objective response.
• The study population for Cohort 1 had a median age of 64 years (interquartile range (IQR): 58–70), with a gender distribution of 56% female and 44% male and an ethnic composition of 65% Asian patients.
• Grade 3 Treatment-Related Adverse Events (TRAEs) were observed in 16 patients (18%), with diarrhea reported in 4 patients (5%) and decreased ejection fraction in 3 patients (3%). No Grade 4 TRAEs or treatment-related deaths were reported.
• Population Types and Subgroup Considerations: Cohort 1 included 80 patients (56% females, 44% males), with 65% identified as Asian, median age 64 years (IQR 58–70). Cohort 2 included 7 patients (71% males, 29% females), with 71% identified as Asian, median age 62 years (IQR 58–77). No clinically significant differences in safety or effectiveness outcomes were observed between subgroups.