Comparative Analysis From Randomized Cohort of Delcath’s FOCUS Study Published

April 14, 2025—Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced the publication of a comparative analysis from the randomized cohort of the company’s phase 3 FOCUS study.

“An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma” was published by Jonathan S. Zager, MD, et al in Annals of Surgical Oncology.

According to Delcath, the study indicated that treatment with the company’s melphalan/hepatic delivery system (HDS) showed a trend toward favorable clinical outcomes compared to best alternative care (BAC), which included the physician’s choice of dacarbazine, transarterial chemoembolization, ipilimumab, or pembrolizumab in patients with unresectable metastatic uveal melanoma with liver involvement.

The company stated that 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.

The randomized portion of the trial enrolled 85 patients with 72 patients receiving study treatment (40 melphalan/HDS; 32 BAC).

In the press release, Delcath reported the following 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 versus BAC, including:
  • Median progression-free survival of 9.1 months versus 3.3 months
  • Median overall survival of 18.5 months versus 14.5 months
  • Objective response rate of 27.5% versus 9.4%
  • Disease control rate of 80.0% versus 46.9%
  • Median hepatic progression-free survival of 11.4 months versus 3.3 months
• The safety profile of patients treated with melphalan/HDS was consistent with previous reports and primarily hematologic in nature. No treatment-related deaths were observed.