Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that a retrospective, multicenter study demonstrated that 45.7 percent of patients with ocular melanoma that metastasized to the liver who underwent percutaneous hepatic perfusion (PHP) using investigational Melphalan/HDS experienced a complete or partial response. The study further showed that among those who responded to treatment, overall survival was projected to be more than three years.
The findings were reported at the Regional Cancer Therapies 12th International Symposium in an oral presentation titled, "Percutaneous Hepatic Perfusion for Unresectable Metastatic Ocular Melanoma to the Liver: A Multi-Institutional Report of Outcomes." The analysis was conducted by teams from Moffitt Cancer Center in Tampa, Fla., and the University Hospital Southampton in the United Kingdom. The presentation was led by Dr. Alexandra Gangi of the Moffitt Cancer Center.
The analysis reviewed outcomes of 49 patients treated between 2008 and 2016 with Melphalan/HDS at either the Moffitt Cancer Center or the University Hospital Southampton. Patients underwent a total of 115 PHP treatments. The median number of treatments per patient was two, with patients receiving one-to-six treatments. PHP is a minimally invasive procedure that isolates the liver from the body’s circulatory system, so that a high dose of chemotherapy (melphalan hydrochloride) may be infused directly into the liver. Blood from the liver is then filtered to remove the chemotherapeutic agent thereby minimizing systemic exposure.
Hepatic response to PHP was evaluable in 46 patients, among whom 45.7 percent showed complete or partial response, and 37.0 percent had stable disease. Median overall survival was not reached, but was projected to be 657 days (1.8 years). Among patients with a complete or partial response, overall survival was projected to be 1,207 days (3.4 years). Most common side effects following treatment were anemia, thrombocytopenia and neutropenia.
Delcath Systems (DCTH) Says Analysis Shows Strong Tumor Response, Overall Survival Potential of It's Investigational PHP Therapy
“Patients diagnosed with metastatic ocular melanoma to the liver have an average of 6-8 months of survival. This retrospective analysis reported a much longer survival after Melphalan/HDS , and provided an interesting long-term look at patient outcomes after treatment with Delcath Melphalan/HDS,” said Dr. Jennifer K. Simpson, President & CEO of Delcath. “The projected 657-day median OS and 1,207 day median OS in those with a partial or complete response is very impressive, and we believe speaks to the potential of the system to provide meaningful durable response.”
PHP with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT®. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.