QUEENSBURY, N.Y. — New clinical data published in the Journal of Cancer Research and Clinical Oncology suggests that Delcath Systems’ HEPZATO KIT provides consistent efficacy for patients battling metastatic uveal melanoma regardless of age, sex, or prior treatment history. The publication reveals subgroup analyses from the pivotal Phase 3 FOCUS study, which served as the foundation for the kit’s FDA approval as the only liver-directed treatment currently available for unresectable cases of this rare cancer. By analyzing 91 patients, researchers found that the drug-device combination, which delivers melphalan directly to the liver, maintained a stable safety profile and consistent tumor response across diverse demographics and geographic regions.
The findings highlight a significant advantage for patients who begin treatment earlier in their disease progression. Specifically, those with a hepatic tumor burden below the median saw a much higher overall response rate of 51.1% compared to just 22.2% in patients with more extensive disease. This trend extended to survival outcomes, as patients with lower tumor involvement survived a median of 22.4 months, notably longer than the 16.8 months recorded for those with higher involvement. Dr. Vojislav Vukovic, Chief Medical Officer of Delcath, noted that these insights underscore the clinical importance of early intervention to maximize the benefits of the therapy.
Data regarding the timing of patient responses also provided a clear roadmap for clinical practice. While over half of the responding patients showed improvement within the first two treatment cycles, a significant one-third of responders did not see results until cycles four through six. This suggests that continuing treatment through the full six-cycle maximum is essential for optimizing outcomes. Throughout these successive cycles, the safety profile remained manageable with no evidence of cumulative toxicity or treatment-related deaths, further validating the therapy as a reliable option for managing this challenging disease.
