Delcath Systems Doses First Patient in Phase 2 DELUMA Trial of HEPZATO for Liver-Dominant Metastatic Breast Cancer
Key Insights
Delcath Systems (search) announced the first patient has been dosed in the global Phase 2 DELUMA trial (NCT06875128) at the European Institute of Oncology in Milan, Italy.
The randomized, controlled trial will evaluate HEPZATO (melphalan hepatic delivery system) plus standard of care versus standard of care alone in approximately 90 patients with liver-dominant HER2-negative metastatic breast cancer (search).
The primary endpoint is hepatic progression-free survival, with secondary endpoints including overall response rate, disease control rate, and overall survival.
Delcath Systems (search), Inc. (Nasdaq: DCTH) announced today that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy, in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC). The milestone marks the company's expansion of its hepatic delivery system platform beyond its current FDA-approved indication in metastatic uveal melanoma (search).
Trial Design and Endpoints
The Phase 2 trial, designated DELUMA and registered as NCT06875128, is a randomized, controlled study designed to evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following failure of previous treatments. The SOC arm will consist of physician's choice of eribulin, vinorelbine, or capecitabine.
Approximately 90 patients will be enrolled across more than 20 sites in the United States and Europe. The trial's primary endpoint is hepatic progression-free survival, with secondary endpoints including progression-free survival, overall response rate, disease control rate, and overall survival.
Unmet Need in HER2-Negative Metastatic Breast Cancer (search)
Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer (search) with liver metastases and are candidates for third-line treatment. This patient population carries a significant burden of liver metastases, which are likely to be the primary cause of mortality. Delcath aims to provide a novel treatment option for these patients, who currently have limited therapeutic alternatives.
"Dosing the first patient in this Phase 2 trial at the IEO in Milan, Italy is an important milestone in our effort to expand the clinical investigation of HEPZATO into liver-dominant metastatic breast cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems (search). "Building on encouraging efficacy signals in real-world evidence presented at ESMO Breast Cancer 2026 and our commercial success in metastatic uveal melanoma (search), we're strengthening how we engage sites, educate physicians on liver-directed therapy, and identify appropriate patients."
HEPZATO Platform and Mechanism
HEPZATO KIT is a combination drug and device product comprising the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is designed to isolate the liver from general circulation during a percutaneous hepatic perfusion (PHP) procedure, enabling the delivery of high-dose melphalan directly to the liver while limiting systemic exposure and associated side effects.
In the United States, HEPZATO KIT is regulated and approved for sale as a drug by the FDA for the treatment of adult patients with metastatic uveal melanoma (search) (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration is regulated as a Class III medical device and marketed under the trade name CHEMOSAT, where it has been used at major medical centers to treat a wide range of liver cancers.
Michel added: "We are encouraged by the momentum we are seeing and look forward to advancing our evaluation of HEPZATO's potential to address significant unmet needs in oncology beyond metastatic uveal melanoma (search)."