Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company specializing in liver-targeted cancer therapies, announced new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) Congress in Barcelona.
The FOCUS trial, a pivotal Phase 3 study, evaluated the efficacy and safety of HEPZATO KIT™ in patients with unresectable hepatic metastases from metastatic uveal melanoma (mUM). The trial’s primary endpoint was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). Out of 102 enrolled patients, 91 received treatment. Full results were published in the Annals of Surgical Oncology on May 4, 2024.
The subgroup analysis focused on 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. No significant differences in OS, ORR, or PFS were observed between patients with and without extrahepatic disease or based on prior treatment. However, patients with more extensive liver involvement had worse OS outcomes, though ORR and PFS remained consistent across liver tumor burden levels.
Tumor responses were observed throughout the treatment period, from the first treatment cycle to the sixth, supporting the strategy of continuing treatment until the best response is achieved. Rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) were stable, indicating no cumulative toxicity, reinforcing the favorable benefit-risk profile of HEPZATO KIT™ for mUM patients with limited treatment options.
Dr. Matthew Wheater noted the encouraging lack of significant outcome differences between patients with and without extrahepatic disease, especially for a liver-directed therapy like Melphalan/HDS. He also emphasized the benefit of continuing treatment beyond two cycles in patients with stable disease.
About Delcath Systems, Inc., HEPZATO KIT™, and CHEMOSAT
Delcath Systems, Inc. specializes in liver cancer therapies. Their proprietary products, HEPZATO KIT™ (melphalan for injection with the Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System, administer high-dose chemotherapy to the liver while minimizing systemic exposure and side effects. In the U.S., HEPZATO KIT is FDA-approved for treating metastatic uveal melanoma (mUM) with unresectable hepatic metastases and certain limited extrahepatic diseases. In Europe, the CHEMOSAT system is approved as a Class III medical device and has been used for percutaneous hepatic perfusion procedures at major medical centers to treat various liver cancers.
