Delcath Systems announces FDA clearance of IND application for Hepzato trial

Delcath Systems (DCTH) 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 breast cancer. With the FDA’s review complete, Delcath is now cleared to initiate patient enrollment in the U.S. The Phase 2 trial will evaluate the safety and efficacy of Hepzato in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029.