Oncology company Delcath Systems Inc (Nasdaq: DCTH) disclosed on Wednesday that it has published subgroup analyses from its phase 3 FOCUS study evaluating the Melphalan/Hepatic Delivery System in patients with unresectable metastatic uveal melanoma, with results appearing in the Journal of Cancer Research and Clinical Oncology.

Analysis assessed efficacy and safety outcomes in 91 patients treated with Delcath Systems' HEPZATO KIT, the only liver-directed therapy approved by the U.S. Food and Drug Administration for unresectable metastatic uveal melanoma. Subgroups were defined by age, sex, geography, extent of liver involvement, hepatic tumour burden, extrahepatic disease, baseline lactate dehydrogenase levels and prior therapies.

Results showed consistent tumour responses across most subgroups, with significantly higher overall response rates and longer progression-free survival in patients with tumour burden below the median. Overall survival was significantly longer in patients with lower liver involvement, lower tumour burden and low or normal baseline lactate dehydrogenase levels.

More than half of responding patients achieved an objective response within the first two treatment cycles, while one-third responded during later cycles, supporting continued treatment through the full six-cycle course. Safety profile was consistent across subgroups, with no evidence of cumulative toxicity, no treatment-related deaths and adverse event rates aligned with the overall study population.

FOCUS study results supported U.S. regulatory approval of HEPZATO KIT, reinforcing its role as a liver-directed treatment option for patients with unresectable metastatic uveal melanoma, according to Delcath Systems.