Delcath Systems Presents New Data Supporting HEPZATO KIT

Delcath Systems announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan using the CHEMOSAT Hepatic Delivery System was presented today at the ESMO Breast Cancer Congress 2026. Patient population: Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1-6). Treatment delivery: Patients received a median of 1 M-PHP cycle (range 1-7), typically followed by ICU admission of 1-2 days. Safety: 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3-4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days. Liver response: Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response. Overall survival: Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9-NR; range 0.1-76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7-NR). "These data from independent European investigators represent real-world evidence supporting the use of HEPZATO KIT and CHEMOSAT in liver-dominant metastatic breast cancer and underscore the need for further evaluation in this heavily pretreated population," said Gerard Michel, Chief Executive Officer of Delcath Systems.