As reported on Business Wire, Delcath Systems has announced the enrollment and dosing of the first patient in its global Phase 2 DELUMA clinical trial, marking a significant step in the investigation of HEPZATO™ as a potential treatment option for patients with liver-dominant metastatic breast cancer (mBC).
The study has commenced at the European Institute of Oncology (IEO) in Milan, Italy, and will assess the effectiveness and safety of HEPZATO when used alongside standard-of-care therapies in patients with HER2-negative metastatic breast cancer whose disease has progressed despite prior treatment.
Trial Design
The randomized, controlled DELUMA trial (NCT06875128) is expected to recruit approximately 90 patients across more than 20 clinical sites in the United States and Europe. Researchers will compare outcomes in patients receiving HEPZATO plus physician-selected standard therapy against those receiving standard therapy alone.
Standard treatment options available within the study include eribulin, vinorelbine, or capecitabine, chosen at the treating physician’s discretion.
The primary objective of the trial is to measure hepatic progression-free survival, while secondary endpoints include overall progression-free survival, response rates, disease control rates, and overall survival.
Addressing an Unmet Need
According to Delcath, roughly 7,000 patients in the United States each year have HER2-negative metastatic breast cancer involving the liver and may be eligible for third-line treatment. Many of these patients develop substantial liver tumor burden, making liver metastases a major driver of disease-related mortality.
By focusing on liver-directed therapy, the company hopes to expand treatment options for a patient population that often faces limited choices after multiple lines of systemic therapy have failed.
Building on Earlier Experience
Delcath CEO Gerard Michel described the first patient dosing as a key milestone in broadening the clinical development of HEPZATO beyond its current use in metastatic uveal melanoma. He noted that the company’s decision to advance the program is supported by encouraging signals from real-world clinical data presented at the ESMO Breast Cancer 2026 meeting, as well as growing commercial experience with the therapy.
Michel added that Delcath is continuing to strengthen site engagement, physician education surrounding liver-directed treatment approaches, and patient identification efforts as the study progresses. The company believes these initiatives could help further evaluate HEPZATO’s potential role in addressing unmet needs among patients with advanced cancers that have spread predominantly to the liver.
If successful, the DELUMA trial could provide important evidence supporting a new therapeutic approach for patients with liver-dominant HER2-negative metastatic breast cancer, a group for whom effective later-line treatment options remain limited.
