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Next-generation sequencing of advanced biliary tract cancers has identified targetable genomic abnormalities, including HER2, IDH1, and FGFR. In a prior phase 1 study, zanidatamab, a bispecific antibody targeting two epitopes of HER2, elicited an objective response in patients with HER2-amplified or HER2-expressing biliary tract cancer (Lancet Oncol 2022; 23:1558.
Investigators now report results of an industry-sponsored, international, single-arm, phase 2b trial of zanidatamab in 80 patients with advanced biliary cancers. Patients had HER2-amplified cancers centrally confirmed by fluorescence in-situ hybridization and immunohistochemistry (IHC) assays; 78% had tumors with an IHC score of 3+, and 23% had tumors with an IHC score of 2+. Half …