Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that results of a large, European single-center experience of the treatment of uveal melanoma patients with hepatic metastases with the Delcath Hepatic CHEMOSAT® Delivery System, were highlighted in an on-line abstract at the American Society of Clinical Oncology Annual Meeting 2015. The abstract is titled, "Single Centre Experience of Chemosaturation Percutaneous Hepatic Perfusion in the Treatment of Metastatic Uveal Melanoma" and can be accessed here.
Uveal melanoma (UM), also known as ocular melanoma, is a rare cancer of the eye with a very poor prognosis. According to the study authors, "50% of patients develop distant disease, mainly in the liver (90%), with a mean survival of 6 months and 1-year survival rate of 15-20%."
In this study, 20 patients received 34 treatments with CHEMOSAT (1-3 treatments per patient). Radiologically, 2 patients (10%) demonstrated stable disease for >3 months, 13 patients (65%) had a partial response in the liver with complete responses in 2 patients (10%). Nine deaths from disease progression occurred after a median of 264 days from the first procedure. Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year. From the diagnosis of liver metastases, 11 patients (55%) have survived to one year and 3 (15%) for >2 years. No procedure related deaths were seen.
Adverse events (AEs) seen were grade 1 (n=12), 2 (n=13), 3 (n=5) and 4 (n=1). The grade 4 complication was pulmonary edema due to fluid overload. Early AEs often expected with percutaneous hepatic perfusion (PHP) were observed including coagulopathy, electrolyte disturbances and transient transaminases (elevated liver enzymes). Rare late AEs (1 patient each) included hair loss, skin rash, myelosuppression and persistent transaminases (elevated liver enzymes).
"Our results show that PHP (CHEMOSAT) can be used safely to control hepatic metastases in selected UM patients with a high rate of hepatic progression free and excellent overall survival," concluded lead study author, Guy Hickson, M.D., Southampton Hospital, Interventional Radiology, Southampton, United Kingdom.
"We are especially pleased to have these data shared with the thousands of oncology specialists from around the world who attend ASCO. We continue to be encouraged by the growing body of European commercial patient experience that illustrates CHEMOSAT's ability to safely and effectively enhance hepatic progression free and overall survival rates in cancer patients with limited treatment options and life-limiting disease," noted Jennifer Simpson, Ph.D., President and Chief Executive Officer of Delcath.
CHEMOSAT is a CE Marked approved product in Europe and is not approved in the United States.