Zymeworks announces zanidatamab results from HERIZON-BTC-01 trial

Zymeworks announced positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in patients with previously treated HER2-amplified and expressing BTC. The positive topline results showed that 41.3% of enrolled patients with HER2-amplified and expressing disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months . The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified. Full results from the pivotal trial are expected to be presented at a medical meeting in 2023. The positive topline results showed that 41.3% of enrolled patients with HER2-amplified and expressing disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months . The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified. Full results from the pivotal trial are expected to be presented at a medical meeting in 2023