Jazz Pharmaceuticals ((JAZZ)) announced an update on their ongoing clinical study.
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Jazz Pharmaceuticals is conducting a pivotal study titled ‘An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer.’ The study aims to evaluate the effectiveness and safety of Zanidatamab combined with standard treatments, including Cisplatin and Gemcitabine, with or without a PD-1/L1 inhibitor, for patients with advanced HER2-positive biliary tract cancer. This research is significant as it could offer a new first-line treatment option for this challenging cancer type.
The intervention being tested is Zanidatamab, an investigational drug administered intravenously. It is being evaluated in combination with standard chemotherapy drugs Cisplatin and Gemcitabine, and optionally with PD-1/L1 inhibitors such as Durvalumab or Pembrolizumab, based on physician choice and local approvals.
This Phase 3 study is designed as an interventional trial with a randomized allocation and a parallel intervention model. The primary purpose is treatment-focused, and there is no masking involved, meaning both participants and researchers know which treatments are being administered.
The study began on July 19, 2024, with primary completion expected in the future. The latest update was submitted on August 19, 2025. These dates are crucial as they mark the progress and timeline for potential results and subsequent regulatory considerations.
The outcome of this study could significantly impact Jazz Pharmaceuticals’ stock performance and investor sentiment. Positive results may enhance the company’s market position in oncology, particularly in the competitive landscape of HER2-positive cancer treatments. Investors should watch for updates as they could influence market dynamics.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.