Delcath’s Hepzato to Be Studied for Liver-Dominant Metastatic Breast Cancer Treatment

April 28, 2025—Delcath Systems, Inc. announced that it has received clearance from the FDA to initiate patient enrollment of a phase 2 clinical trial evaluating the company’s Hepzato in combination with standard of care (SOC) to treat liver-dominant metastatic breast cancer (mBC). The clearance comes after the FDA completed its 30-day review of Delcath’s Investigational New Drug application for the trial, advised the company.

According to the company, 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 after the failure of previous treatments. The SOC options in the trial will be the physician’s choice of eribulin, vinorelbine, or capecitabine.

Delcath stated that the randomized controlled trial will comprise approximately 90 patients enrolled at more than 20 sites across the United States and Europe. Patient enrollment is 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. Results for overall survival, a secondary endpoint, are expected in 2029.

As noted in the company’s press release, Delcath Systems’ Hepzato Kit (Hepzato [melphalan] for injection hepatic delivery system) and Chemosat hepatic delivery system for melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, Hepzato Kit is considered a combination drug-and-device product. It is regulated and approved for sale as a drug by the FDA. In Europe, the device-only configuration of the HDS is regulated as a class III medical device and is approved for sale under the trade name Chemosat, advised Delcath.