Positive Phase 2 Trial Results From Neuroendocrine Tumor Cohort Presented At CIRSE
Delcath Systems, Inc. (NASDAQ: DCTH) announced that updated results from the metastatic neuroendocrine tumor (mNET) cohort of the Company’s recently completed Phase 2 clinical trial were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress held this week in Munich, Germany. James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a Principal Investigator of the Phase 2 trial, presented the late-breaking abstract on September 12, 2011 at 4:45pm during an Oncologic Intervention oral abstract session.
In the Phase 2 trial’s mNET cohort, 24 patients with unresectable mNET in the liver underwent an average of 3 chemosaturation procedures with concentrated melphalan and subsequent extra-corporeal venous hemofiltration. The primary endpoint of overall hepatic response rate (ORR) among the 20 evaluable patients was 70%, including one patient who presented with a confirmed complete response (CR) and 13 with confirmed partial responses (PR). Four patients had stable disease (SD) and 2 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 ITT 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 3 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 2 study is very positive, and suggest a potential role for chemosaturation in this difficult to treat population,” said Eamonn P. Hobbs, President & 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 2 study was conducted at the National Cancer Institute (NCI) in the U.S., and included four cohorts enrolling patients with hepatobiliary cancers, as well as metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) 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. Top-line results from the trial’s hepatobiliary cohort were announced August 22, 2011; and from the metastatic colorectal cohort on September 1, 2011.
About mNET
Neuroendocrine tumors (NETs) are a group of malignant tumors that originate from intersections of the nervous system and endocrine (glandular) system throughout the body and are found in various locations, such as the pancreas, thyroid, lungs, gastrointestinal tract and biliary system. Nearly 9,000 patients in Europe have neuroendocrine tumors metastases in the liver, which is the most common site for neuroendocrine tumors to metastasize. Surgery is an accepted treatment for mNETs, but the type and extent of surgery for liver metastasis is contingent upon tumor size, disease progression, site of origin and other factors including the age and heath of the patient. Recent published data from the control arms of randomized controlled trials in pancreatic NET show that progression-free survival is of the order of 6 months without treatment.
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.
Delcath Systems, Inc