Delcath Systems Publishes FOCUS Study Subgroup Analysis Results

Delcath Systems announced the publication of results from subgroup analyses of the phase 3 FOCUS study. The publication was published in the Journal of Cancer Research and Clinical Oncology. The analysis assessed efficacy and safety in subgroups of patients treated with Delcath's Hepzato Kit, a drug/device combination for liver-directed treatment of mUM patients. The Hepzato Kit is currently the only liver-directed treatment to be approved by the FDA for patients with unresectable mUM. The article provides clinically relevant subgroup analyses of key efficacy endpoints, including overall response rate, progression-free survival and overall survival, and safety categories. Prespecified subgroups included age, sex, geographic region, extent of tumor liver involvement, hepatic tumor burden, presence of extrahepatic lesions, baseline LDH and number of prior therapies. This prespecified analysis of clinically relevant subgroups included 91 patients treated in the FOCUS study. Key efficacy and safety findings include: consistent tumor response was observed regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy. Significantly higher ORR for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median PFS for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median OS for patients with smaller extent of tumor liver involvement, tumor burden below the median and low/normal LDH. Of the 33 patients achieving an objective response, 57.6% responded within the first or second treatment cycle, while one-third of responses were observed in Cycles 4-6. The overall safety profile was similar across subgroups, with no evidence of cumulative toxicity with successive treatment cycles. The incidence of serious adverse events and Grade 3/4 adverse events was consistent with the overall study population, and no treatment-related deaths occurred.