Melphalan/HDS efficacious, has favorable risk-benefit profile for unresectable metastatic uveal melanoma
By Elana Gotkine HealthDay Reporter
THURSDAY, April 24, 2025 (HealthDay News) — For patients with unresectable metastatic uveal melanoma (mUM), the drug/device combination melphalan/hepatic delivery system (HDS) is efficacious and has a favorable risk-benefit profile compared with best alternative care (BAC), according to a study published online April 7 in the Annals of Surgical Oncology.
Jonathan S. Zager, M.D., from the Moffit Cancer Center in Tampa, Florida, and colleagues randomly assigned 85 eligible patients with unresectable mUM to receive melphalan/HDS 3 mg/kg ideal body weight once every six to eight weeks for a maximum of six cycles or BAC (43 and 42 patients, respectively); 72 patients actually received study treatment (40 and 32 patients, respectively). The study design was amended to a single-arm melphalan/HDS study, and all efficacy analyses of the randomized study were treated as exploratory.
The researchers observed numerical differences consistently favoring the melphalan/HDS arm versus BAC in exploratory analyses of efficacy end points (median overall survival, 18.5 versus 14.5 months; median progression-free survival, 9.1 versus 3.3 months; objective response rate, 27.5 versus 9.4 percent; disease control rate, 80.0 versus 46.9 percent). Serious adverse events occurred in 51.2 and 21.9 percent of patients receiving melphalan/HDS and BAC, respectively. Thrombocytopenia, neutropenia, leukopenia, and febrile neutropenia were the most common serious adverse events in patients receiving melphalan/HDS (19.5, 9.8, 9.8, and 7.3 percent, respectively), while in patients receiving BAC, cholecystitis, nausea, and vomiting were the most common serious adverse events (6.3 percent each). There were no treatment-related deaths reported.
“This therapy offers a treatment option for patients with this rare condition which is associated with a poor prognosis and limited treatment options,” the authors write.
Several authors disclosed ties to the pharmaceutical industry; the study was funded by Delcath Systems.
Copyright © 2025 HealthDay. All rights reserved.
