Delcath wins positive review from DSMB for Phase III melanoma study

Delcath Systems, a medical technology company, has reported that the data and safety monitoring board has unanimously recommended continuation of the company’s Phase III clinical trial for inoperable metastatic melanoma.

The data and safety monitoring board (DSMB) reviewed clinical data on the first 51 patients enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver.

After reviewing the data on more than one half of the required patients in this trial, the DSMB unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study.

The current 11 participating cancer centers in this trial will continue to evaluate and enroll patients and the DSMB is slated to review updated clinical data following recruitment of the 69th patient, which would mark the 75% enrollment point for this trial.

The Phase III study is testing Delcath’s Percutaneous Hepatic Perfusion System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. Delcath said that the system is designed to deliver significantly higher doses of anticancer drugs to a patient’s liver while preventing entry of the drugs to the rest of the patient’s circulation. This isolation limits toxicities that result from systemic chemotherapy treatments, according to Delcath.