Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System

Delcath Systems, Inc. DCTH 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 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 3 melanoma trial.