Delcath Systems Inc. announced the publication of subgroup analyses from the Phase 3 FOCUS study evaluating the Melphalan/Hepatic Delivery System (HEPZATO KIT) in patients with unresectable metastatic uveal melanoma. The results, published in the Journal of Cancer Research and Clinical Oncology, assessed efficacy and safety across subgroups defined by age, sex, geographic region, liver tumor involvement, hepatic tumor burden, presence of extrahepatic lesions, baseline LDH levels, and number of prior therapies. The analyses found a consistent safety profile and efficacy across the evaluated subgroups, with no evidence of cumulative toxicity or treatment-related deaths. These results have already been published and contributed to the FDA approval of the HEPZATO KIT for this indication.

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