Delcath Systems has reported encouraging top-line results from the hepatobiliary cohort of the phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer.
This study, conducted at the National Cancer Institute, included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.
There were nine patients with tumors of hepatobiliary origin: five hepatocellular carcinomas (HCC) and four cholangiocarcinomas. HCC is the most common primary cancer of the liver, with approximately 500,000 new cases diagnosed worldwide annually. Both groups had positive efficacy signals. The responses were especially encouraging in the HCC cohort and consisted of confirmed partial response or durable stable disease. The safety profile of the chemosaturation system was consistent with that previously reported for the company's phase III melanoma trial.
The trial's primary objectives were to determine the response rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration. Secondary objective measures included patterns of recurrence, progression-free survival and overall survival. Additional secondary objectives were to evaluate safety and tolerability in this patient population, and assess filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors.