Results of Single Center Prospective Study on Delcath’s PHP Therapy Presented at ECIO 2019

On April 16, 2019 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a prospective phase 2 study conducted by Leiden University Medical Center (LUMC) in the Netherlands on the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases were presented at the European Conference on Interventional Oncology (ECIO) annual meeting (Press release, Delcath Systems, APR 16, 2019, View Source [SID1234535164]).

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The LUMC study, Percutaneous hepatic perfusion with melphalan in patients with unresectable liver metastases from ocular melanoma using the Delcath System’s second-generation hemofiltration system: a prospective phase II study, was conducted by a team led and presented by Dr. Mark Burgmans. The study evaluated 35 patients with unresectable liver metastases from ocular melanoma treated with CHEMOSAT between February 2014 and June 2017. The 35 patients underwent a total of 72 PHP treatments, and tumor response was evaluable in 32 patients. Primary endpoints were overall response, overall survival, and progression free survival. Secondary measures included safety measures and hematologic toxicity.

Results of the study showed that one patient had a complete response and 22 had partial response, for a combined overall response rate of 74.1%. Overall survival was 20.3 months and mean progression free survival was 8.1 months.

Safety analysis showed a total of 14 serious adverse events were recorded. The hematologic toxicities were in a majority of the cases self-limiting and manageable. Investigators concluded that "PHP Therapy with the Generation Two version of CHEMOSAT is an effective and safe treatment for patients with hepatic metastases from ocular melanoma."

The ECIO 2019 conference was held April 8-11 in Amsterdam, the Netherlands.