Delcath Systems announces new data presented at ESMO 2024 demonstrating efficacy of HEPZATO KIT in subsets of metastatic uveal melanoma

Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the Phase 3 FOCUS trial of HEPZATO KIT (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater of University Hospital Southampton at the European Society for Medical Oncology (ESMO) Congress in Barcelona.

The FOCUS study was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT in patients with unresectable liver metastases from mUM. The primary endpoint of the study was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). The study included 102 patients, 91 of whom received treatment. The full results of the FOCUS study were published in the Annals of Surgical Oncology on May 4, 2024.