HEPZATO

July 9, 2026: Delcath Systems, Inc. (NASDAQ: DCTH) announced the first patient was dosed at the European Institute of Oncology (IEO) in Milan, Italy in its global Phase 2 DELUMA trial (NCT06875128) evaluating HEPZATO plus standard of care (SOC) versus SOC alone for liver-dominant HER2-negative metastatic breast cancer after failure of prior treatments. The randomized, controlled study plans to enroll ~90 patients across >20 sites in the U.S. and Europe, with SOC as physician’s choice of eribulin, vinorelbine, or capecitabine. Primary endpoint is hepatic progression-free survival; secondary endpoints include progression-free survival, overall response rate, disease control rate, and overall survival. The company cited encouraging real-world evidence signals presented at ESMO Breast Cancer 2026 and noted HEPZATO KIT is FDA-approved in the U.S. for certain patients with metastatic uveal melanoma with unresectable hepatic metastases.