Delcath Systems announced the publication of results from the pivotal Phase 3 FOCUS study of Hepzato Kit – melphalan/Hepatic Delivery System – in patients with unresectable metastatic Uveal Melanoma on May 5 in the journal Annals of Surgical Oncology. The FDA approved Hepzato Kit in 2023 based on the results from the pivotal FOCUS study. The primary efficacy endpoint of the FOCUS study was Overall Response Rate, which was 36.3%, including 7.7% of patients with Complete Response. 37.4% of patients had Stable Disease. ORR achieved in the FOCUS study was compared to a Meta-analysis of historic data. ORR of 36.3% in the FOCUS study was statistically significantly better than the pooled ORR estimate of 5.5% in the historical control group. Safety and tolerability of HEPZATO KIT treatment reported in the FOCUS study was comparable with published clinical experience with Chemosat in Europe. Hepzato is the only liver-directed treatment for unresectable mUM patients approved by the FDA.
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