Delcath Systems Starts Phase 2 HEPZATO Trial in Liver-Dominant Metastatic Breast Cancer

Delcath Systems Inc. (NASDAQ: DCTH) has dosed the first patient in its Phase 2 clinical trial evaluating HEPZATO in people with liver-dominant metastatic breast cancer (mBC). This marks a key step in expanding HEPZATO beyond its current use in metastatic uveal melanoma to another difficult-to-treat cancer setting.

 What this Phase 2 trial is testing

The randomized Phase 2 study will compare HEPZATO in combination with standard-of-care (SOC) treatment versus SOC alone in patients with HER2-negative metastatic breast cancer whose disease is mainly in the liver and who have already failed prior therapies.

• SOC options in the trial include eribulin, vinorelbine, or capecitabine, chosen by the treating physician.
• About 90 patients are expected to enroll across more than 20 sites in the United States and Europe.
• The primary endpoint is hepatic progression-free survival, with overall survival as a key secondary endpoint.

Liver-dominant disease in metastatic breast cancer is associated with poor outcomes and limited treatment options, particularly in HER2-negative patients, so this study is targeting a high unmet-need population.

 What HEPZATO does

HEPZATO is Delcath’s proprietary version of percutaneous hepatic perfusion (PHP) with high-dose melphalan, delivered directly to the liver while filtering the blood to help limit systemic exposure.

• The company already has approval in the U.S. for HEPZATO KIT in metastatic uveal melanoma involving the liver, and CHEMOSAT (a related system) has been used in Europe.stocktitan+1
• Retrospective data from independent European centers in liver-dominant metastatic breast cancer showed that M-PHP (CHEMOSAT) produced hepatic partial responses in 60% of patients in a heavily pretreated group, supporting further prospective study.

Delcath sees this Phase 2 trial as a way to build evidence that the same liver-directed platform can help additional tumor types where the liver is the main site of disease.

 Why this matters for patients and investors

For patients with liver-dominant HER2-negative metastatic breast cancer, options after multiple lines of therapy are limited, and prognosis can be poor. A therapy that specifically targets liver metastases while allowing systemic treatment to continue may offer a new approach if the data are positive.

For investors, this Phase 2 study is part of Delcath Systems’ broader strategy to expand HEPZATO’s addressable market beyond uveal melanoma into additional liver-dominant cancers. Success in this trial could support future registrational plans and strengthen the company’s case that HEPZATO is a platform technology rather than a single-indication product.