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December 2, 2024
Delcath Systems to Initiate Phase 2 Trial of Hepzato in Liver-Dominant mCRC
December 2, 2024—Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that the FDA has completed its 30-day review of the company’s investigational new drug application for a phase 2 clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic colorectal cancer (mCRC).
The company stated that with completion of the review, it is now authorized to initiate patient enrollment.
According to Delcath, the phase 2 trial will evaluate the safety and efficacy of Hepzato in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment.
The company stated that the randomized, controlled trial will enroll approximately 90 patients at more than 20 sites across the United States and Europe. Patient enrollment is expected to begin in the second half of 2025.
The trial’s primary endpoint of hepatic progression-free survival is anticipated to read out by the end of 2027. A secondary endpoint of overall survival is expected in 2028, advised Delcath.
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