Zanidatamab
Zanidatamab (ZW25), is a novel bispecific (dual-targeting) antibody that simultaneously binds two distinct domains of the HER2 receptor. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. In clinical trials, zanidatamab monotherapy and zanidatamab in combination with chemotherapy have been well tolerated with promising antitumor activity in patients with heavily pretreated HER2-expressing cancers that have progressed after having received standard of care, including multiple HER2-targeted regimens. Based on these data, zanidatamab was granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01). In addition, several global multicenter Phase 2 clinical trials were initiated, including: the first-line treatment of metastatic HER2-positive gastroesophageal adenocarcinomas in combination with standard of care chemotherapy, and previously-treated locally advanced and/or metastatic HER2-positive, hormone receptor-positive breast cancer in combination with Pfizer’s Ibrance® (palbociclib) and fulvestrant. Our partner, BeiGene, has initiated Phase 1b/2 clinical trials evaluating zanidatamab for the first-line treatment of metastatic HER2-positive breast cancer in combination with docetaxel and for the first-line treatment of metastatic HER2-positive gastroesophageal adenocarcinomas in combination with tislelizumab and chemotherapy. In addition, zanidatamab continues to be evaluated in several indications including colorectal, endometrial and other HER2-expressing cancers....
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