Delcath Systems, Inc. announced that the first patient has been dosed in its global Phase 2 Clinical Trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer (mCRC). The dosing occurred at the City of Hope National Medical Center.
The Phase 2 trial is designed to assess the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab, compared to SOC alone, in approximately 90 patients receiving third-line treatment for liver-dominant mCRC. The study will be conducted at more than 20 sites across the United States and Europe.
Results from the trial's primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, with overall survival (OS) results expected in late 2028. This milestone represents a significant step in exploring HEPZATO's potential to address an annual addressable market of 6,000 to 10,000 patients in the U.S. for this indication.
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