, /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: ) today announced long-term follow-up results, including the first-ever overall survival (OS) findings, from the Phase HERIZON-BTC-01 clinical trial of zanidatamab in previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). These data will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting in a poster presentation during the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary session on , at . Zanidatamab is a human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody being studied in multiple solid tumors.
For the trial's primary endpoint, results demonstrated that a confirmed objective response rate (cORR) by independent central review (ICR) was maintained at 41.3% (95% confidence interval (CI): 30.4, 52.
8) and one additional patient achieved a complete response (n=2; 2.5%) since initial findings were presented at the . The median duration of response (DoR), one of the trial's key secondary endpoints, increased by approximately 2 months to 14.
9 months (95% CI: 7.4, not reached), compared to the previously reported findings. In this data cut, zanidatamab demonstrated a median estimated OS, another secondary endpoint, of 15.
5 months (95% CI: 10.4, 18.5) in all patients with HER2+ BTC, 18.
1 months (95% CI:12.2, 23.2) in patients with IHC 3+ tumors, and 5.
2 months (95% CI: 3.1, 10.2) in patients with IHC 2+ .
