Zanidatamab monotherapy induces response in biliary tract cancers
Zanidatamab monotherapy appeared active among patients with HER2-amplified and -expressing biliary tract cancer, according to the agent’s manufacturer.
Zanidatamab (Zymeworks) is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2.
The open-label, single-arm phase 2b HERIZON-BTC-01 trial investigated zanidatamab as monotherapy for patients with previously treated HER2-amplified and expressing biliary tract cancers.
Confirmed ORR by independent central review served as the primary endpoint. Secondary endpoints included duration of response, proportion of patients who maintained response for at least 16 weeks, disease control rate, PFS, OS and safety.
Researchers reported an ORR of 41.3% (95% CI, 30.4-52.8) and median response duration of 12.9 months (95% CI, 5.95-not reached).
Zanidatamab exhibited a safety profile consistent with prior reports. Investigators observed no new safety signals.
Complete results from the trial are expected to be submitted at a medical meeting.
“We are thrilled to report these positive topline data from the HERIZON-BTC-01 clinical trial, which further support the potential of zanidatamab as a new chemotherapy-free therapeutic option for HER2-amplified and -expressing [biliary tract cancers],” Neil Josephson, MD, chief medical officer at Zymeworks, said in a company-issued press release. “These data demonstrate that zanidatamab as a single agent improves on the current standard of care for patients in a difficult-to-treat disease who currently have a poor prognosis based on the limited treatment options currently available.”
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