Delcath Systems has reported top-line results from the metastatic colorectal (adenocarcinoma) cohort of a Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer, indicating the need for a further trial.
The Delcath chemosaturation system is designed to administer high-dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.
The multi-arm Phase II study, conducted at the National Cancer Institute in the US, included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal origins.
Sixteen patients with late-stage colorectal cancer liver metastases were recruited into the trial.
The safety profile of the chemosaturation system is consistent with that previously reported for the company’s Phase III melanoma trial.
The efficacy signal from this study is inconclusive and thus there is a need to conduct a new Phase II trial in a well-defined metastatic colorectal patient population who are likely to benefit from chemosaturation with percutaneous hepatic perfusion.
The company will initiate a new Phase II single-arm study in the second half of next year to evaluate the efficacy of the chemosaturation system and its next-generation, high-efficiency filter in patients with colorectal cancer.