On September 16, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, reported the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM) (Press release, Delcath Systems, SEP 16, 2024, View Source [SID1234646648]). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona.
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The FOCUS trial was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT in patients with unresectable hepatic metastases from mUM. The primary endpoint of the study was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). The trial enrolled 102 patients, of whom 91 received treatment. The full results of the FOCUS trial were published on May 4, 2024, in the Annals of Surgical Oncology.
The subgroup analysis evaluated patients with and without extrahepatic disease, treatment-naive versus previously treated patients, and those with low (1-25%) versus high (26-50%) liver tumor burden. There were no significant differences in OS, ORR, or PFS between patients with and without extrahepatic lesions or based on prior therapy. While ORR and PFS remained consistent regardless of liver tumor burden, more extensive liver involvement was associated with worse OS outcomes.
Objective tumor responses were observed throughout the entire treatment period; the earliest following completion of the first treatment cycle, and the latest following treatment cycle 6. This result supports the strategy to continue treatment until best response is achieved. Rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) remained consistent, indicating an absence of cumulative toxicity. These findings underscore the favorable benefit-risk profile of HEPZATO KIT in this patient population, offering a meaningful option for patients who typically have limited treatment options.
Dr. Wheater commented, "The lack of significant differences in outcomes between patients with and without extrahepatic disease is encouraging, particularly for a liver-directed therapy like Melphalan/HDS. Additionally, the fact that responses were observed through all six treatment cycles supports the strategy of continuing treatment beyond two cycles in patients with stable disease."