Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of a comparative analysis from the randomized cohort of the Company’s Phase 3 FOCUS study in Annals of Surgical Oncology. The study, titled “An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma,” indicates that treatment with the Melphalan/Hepatic Delivery System (Melphalan/HDS) shows a trend toward favorable clinical outcomes compared to best alternative care (BAC), which included the physician’s choice of dacarbazine, transarterial chemoembolization (TACE), ipilimumab or pembrolizumab in patients with unresectable metastatic uveal melanoma (mUM) with liver involvement.
The FOCUS study was initially designed and conducted as a randomized controlled trial but was amended to a single-arm design. As a result, comparative efficacy analyses were designated as exploratory. A total of 85 patients were enrolled during the randomized portion of the trial, with 72 receiving study treatment (40 Melphalan/HDS; 32 BAC).
Key Findings from the Randomized Portion of the FOCUS Study:
- All efficacy endpoints of the trial demonstrated substantial and consistent improvements in patients treated with Melphalan/HDS over BAC, including:
- Median progression-free survival in patients treated with Melphalan/HDS was 9.1 months, nearly three times longer than the 3.3 months observed in patients treated with BAC
- Median overall survival was 18.5 months for Melphalan/HDS compared to 14.5 months with BAC
- Objective response rate was 27.5% with Melphalan/HDS, nearly three times higher than 9.4% with BAC
- Disease control rate was 80.0% with Melphalan/HDS, substantially higher than the 46.9% observed with BAC
- Median hepatic progression-free survival was 11.4 months for Melphalan/HDS – more than three times longer than the 3.3 months for BAC
- The safety profile of patients treated with Melphalan/HDS was consistent with prior reports and primarily hematologic in nature. No treatment-related deaths were observed.
“These results further support the use of our hepatic delivery system as a liver-directed treatment option for patients with metastatic uveal melanoma,” said Dr. Vojislav Vukovic, Chief Medical Officer at Delcath. “Melphalan/HDS delivered meaningful improvements across all clinical endpoints, including progression-free survival, overall survival, disease control, and hepatic outcomes. The findings, while exploratory in nature, reinforce our belief that effective management of liver disease is key to improving outcomes in this patient population, and we are proud to contribute a therapy with both clinical impact and the ability to be administered repeatedly.”
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