What is the efficacy of zanidatamab-hrii for injection-Ziihera?

Zenidatamab-hrii for injection (zanidatamab-hrii)-Ziihera is a novel humanized IgG1-like HER2-targeting bispecific antibody specifically targeting patients with HER2-positive biliary tract cancer. The drug combines two unique domains of HER2 and shows significant clinical efficacy. In the ongoing Phase 2b HERIZON-BTC-01 trial, the drug's efficacy and safety were initially verified.

According to the results ofHERIZON-BTC-01 trial, at a median follow-up of 12.4 months, zenidatuzumab demonstrated a confirmed objective response rate (cORR) of 41.3% and a disease control rate (DCR) of 68.8% in patients previously treated for HER2-positive biliary cancer. These results are consistent with the study's preliminary analysis, showing promising clinical benefit from the drug in specific patient populations. Additionally, two patients in the study achieved complete remission (CR), further demonstrating the drug's potential.

Long-term follow-up data show that the median duration of response (DOR) has increased to 14.9 months (95% CI, 7.4-not reached), demonstrating the durable efficacy of zenidatuzumab. For patients with immunohistochemistry (IHC) 2+ or 3+, the median overall survival (OS) was 15.5 months (95% CI, 10.4-18.5), and the 6- and 12-month OS rates were 80.3% (95% CI, 69.4%-87.6%) and 56.2% (95% CI, 44.3%-66.5%), respectively. These data indicate that zenidatuzumab can effectively improve the survival prognosis of patients with advanced biliary tract cancer.

Biliary tract cancer, a malignant tumor with poor prognosis, accounts for less than 1% of all adult cancers. Patients who still need to continue chemotherapy after first-line treatment in the past often have poor tolerance, and the median OS is only 6-9 months. Therefore, the application of zenidatuzumab provides a new treatment option for these patients, especially those with unresectable, locally advanced or metastatic HER2-positive biliary tract cancer.

Reference materials:https://www.targetedonc.com/view/longer-follow-up-confirms-durability-of-zanidatamab-in-pretreated-her2-btc