Delcath Systems has announced the publication of a retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany.
The study, titled ‘Survival outcome after percutaneous hepatic perfusion with high-dose melphalan for liver-dominant metastatic uveal melanoma: A 10-year single-center experience’, was published in the journal Cancers and reports outcomes from 38 consecutive patients with liver-dominant metastatic uveal melanoma (mUM) who underwent 99 procedures using Delcath’s Chemostat hepatic delivery system for Melphalan percutaneous hepatic perfusion (PHP). The article highlights the procedure’s safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles.
“The publication of this 10-year experience in Cancers underscores the significant clinical evidence supporting the use of PHP as an effective liver-directed therapy for patients with liver-dominant metastatic uveal melanoma,” said Gerard Michel, chief executive officer of Delcath systems. “These results from a high-volume specialised centre show a median OS approaching 2.5 years, surpassing prior reports and reinforcing the potential survival benefits of treatment with repeated PHP cycles. We are pleased to see this data add to the collection of research supporting Hepzato Kit and Chemostat, which aligns with our commitment to advancing treatment options in interventional oncology.”
The retrospective study synthesises data from consecutive patients treated between April 2014 and March 2024, demonstrating safety and efficacy of Chemostat in a real-world setting. Key highlights include:
- Median OS of 29.1 months (95% confidence interval [CI]: 18.4–38.9 months) from the first PHP treatment, with one-, two-, and three-year OS rates of 79.5%, 53.2%, and 28.5%, respectively.
- Numerically improved median OS with ≥3 PHP cycles (29.8 months) versus ≤2 cycles (21.4 months; p=0.058), with each additional cycle associated with an approximate 40% reduction in risk of death (hazard ratio [HR]=0.414).
- No treatment-related deaths, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients.
- Patient population with Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, ≤70% liver involvement, and limited extrahepatic disease, reflecting appropriate selection for PHP.
- Support for institutional experience and volume as factors in optimising outcomes, providing a reference for novel mUM management strategies.
