Delcath System’s Chemosat for Metastatic Uveal Melanoma Evaluated in Comparative Study

September 11, 2023—Delcath Systems, Inc. announced the presentation of a retrospective comparative study of treatments for patients with liver-dominant uveal melanoma that was conducted by independent investigators at the University Hospital at Tubingen, Germany.

The study was composed of two cohorts of patients treated with multiple cycles of either transarterial radioembolization using selective internal radiation therapy (SIRT, n = 34) or chemosaturation-percutaneous hepatic perfusion [CS-PHP, n = 28) of melphalan with Delcath System’s Chemosat.

The oral presentation by Professor Gerd Groezinger, MD, from the University of Tubingen was delivered at CIRSE 2023, the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting held September 9-13 in Copenhagen, Denmark.

The company stated that Chemosat is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. Chemosat is designated under the European Union’s medical device regulation for use in Europe and in the United Kingdom.

According to the company, the findings for SIRT versus CS-PHP included the following:

• The rate of objective tumor response was 5% versus 9%.
• Median overall survival was 301 versus 516 days; adjusted Cox regression analysis showed a significant difference (P = .006).
• Median progression-free survival was 127.5 versus 408.5 days; adjusted Cox regression analysis showed a trend favoring CS-PHP without reaching statistical significance (P = .09).

“Liver-directed treatment, including transarterial radioembolization and CS-PHP, is a critical treatment modality for patients with metastatic uveal melanoma,” commented Prof. Groezinger in Delcath’s press release. “Given the longer overall survival seen in the CS-PHP cohort, we conclude that for metastatic uveal melanoma patients, CS-PHP might be the superior liver-directed treatment option.”