On May 7, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT Hepatic Delivery System was presented today at the ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026.
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Presentation details
Congress: ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026
Date: May 7, 2026
Session: 13:15 (local congress time)
Format: E-poster
Title: Safety and Feasibility of Percutaneous Hepatic Perfusion with Melphalan in Patients with Liver-Dominant Metastatic Breast Cancer
Presenter: Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School)
Abstract number: 574eP
Background
Liver-dominant metastatic breast cancer remains a significant clinical challenge, as progression in the liver can be a major driver of morbidity and may limit the effectiveness of systemic therapies. M-PHP is a liver-directed procedure designed to deliver high-dose melphalan to the liver while reducing systemic exposure through extracorporeal hemofiltration.
About the analysis
Independent investigators at three European centers retrospectively identified 15 patients with liver-dominant metastatic breast cancer treated with M-PHP (CHEMOSAT) at three European centers. The analysis evaluated feasibility, safety, and tumor response per RECIST v1.1.
Key findings (retrospective cohort; N=15)
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.
HEPZATO KIT is currently being evaluated in a randomized Phase 2 trial in metastatic breast cancer patients with liver dominant disease (PHP-MBC-202; ClinicalTrials.gov identifier NCT06875128).
(Press release, Delcath Systems, MAY 7, 2026, View Source [SID1234665320])