Delcath Systems, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the company's Investigational New Drug (IND) application for a Phase 2 clinical trial. This clearance authorizes Delcath to initiate patient enrollment for evaluating HEPZATO in liver-dominant metastatic colorectal cancer (mCRC).
The Phase 2 trial will assess the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab, compared to standard of care alone, in approximately 90 patients receiving third-line treatment for liver-dominant mCRC. The study will be conducted at over 20 sites across the United States and Europe, with enrollment expected to begin in the second half of 2025.
The primary endpoint for the trial is hepatic progression-free survival (hPFS), with results anticipated by the end of 2027. Delcath estimates the annual addressable market for liver-dominant mCRC receiving third-line treatment in the U.S. to be between 6,000 and 10,000 patients, representing a substantial expansion opportunity for the company.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.