In the phase II trial’s mNET cohort, 24 patients with unresectable mNET in the liver underwent an average of three chemosaturation procedures with concentrated melphalan and subsequent extra-corporeal venous hemofiltration. The primary endpoint of overall hepatic response rate among the 20 evaluable patients was 70%, including one patient who presented with a confirmed complete response and 13 with confirmed partial responses. Four patients had stable disease and two progressed at their first evaluation, giving a tumor growth control rate of 90%. As for secondary endpoints, the median overall survival in all 24 patients (on an intent to treat or basis) was reported as 30.4. months. The safety profile of the chemosaturation system was consistent with that previously reported for the company’s phase III melanoma trial.
“Currently available treatment options for patients with unresectable neuroendocrine liver metastases have response rates around 5%. The anti-tumor activity and duration of response seen in the mNET arm of this phase II study is very positive, and suggests a potential role for chemosaturation in this difficult to treat population” said Eamonn P Hobbs, president and CEO of Delcath. “More importantly, we believe these results provide a strong signal of efficacy in liver metastases other than melanoma, and support our belief that chemosaturation will eventually play a broad role in disease control in the liver.”
The phase II study was conducted at the National Cancer Institute (NCI) in the USA and included four cohorts enrolling patients with hepatobiliary cancers, as well as metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal origins. The 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 hepatic PFS, overall survival, safety and tolerability.
About the hepatic Chemosat delivery system
Chemosat allows the administration of concentrated regional chemotherapy by isolating the circulatory system of the liver using specially-designed catheters that are inserted in the groin and sit in the hepatic artery and inferior vena cava. Once the liver is isolated, the chemosaturation system delivers high-concentration chemotherapy, such as melphalan hydrochloride, directly to the liver. To limit systemic exposure and the related side effects, blood from the liver is redirected through an isolation-aspiration catheter to extracorporeal filters, which reduce the concentration of chemotherapeutic agent in the blood before it is returned to the patient. The procedure is minimally invasive and repeatable allowing for multiple courses of treatment.
