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Jazz Pharmaceuticals Presents Overall Survival and Longer Follow-Up Data from HERIZON-BTC-01 Trial Evaluating Zanidatamab in Previously Treated HER2-Positive Biliary Tract Cancer at ASCO 2024
Zanidatamab demonstrated a median overall survival (OS) of 15.5 months in patients with centrally confirmed immunohistochemistry (IHC) 2+ or 3+ and a median
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Zanidatamab demonstrated a median overall survival (OS) of 15.5 months in patients with centrally confirmed immunohistochemistry (IHC) 2+ or 3+ and a median OS of 18.1 months in patients with IHC 3+ tumors\nWith approximately two years of median follow-up, as of July 28, 2023, median duration of response (DOR) increased by two months from initial analysis to 14.9 months \nDUBLIN, June 1, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced long-term follow-up results, including the first-ever overall survival (OS) findings, from the Phase 2b 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 June 1, 2024, at 1:30-4:30 p.m. CDT. Zanidatamab is a human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody being studied in multiple solid tumors.\nFor 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 ASCO Annual Meeting in 2023. 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+ tumors. Results highlight the clinically meaningful benefits of sustained and durable responses with continued treatment with zanidatamab.\n\"Patients with BTC are typically diagnosed when their disease is at an advanced stage, which is associated with a poor prognosis,\" said Shubham Pant, M.D., M.B.B.S. professor in the Department of Gastrointestinal Medical Oncology and Investigational Cancer Therapeutics a...