Phase III trial comparing PHP with melphalan to BAC for hepatic metastases highlighted at ASCO 2010

Delcath Systems, Inc.Jun 7 2010

Delcath Systems, Inc. (Nasdaq: DCTH) a development stage, specialty pharmaceutical and medical device company focused on oncology, highlighted the Phase III trial data presented on June 5 at the American Society of Clinical Oncology's 2010 Annual Meeting, comparing percutaneous hepatic perfusion (PHP) with melphalan to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma.  James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a lead Principal Investigator of the Phase III trial, presented the late-breaking abstract on June 5 at 3:30 PM CT, during the Melanoma/Skin Cancer – Oral Abstract Session.  

In the PHP arm of the study, patients showed median hepatic progression free survival (hPFS) of 245 days compared to 49 days in the BAC arm, a 5x extension of hPFS.  Median overall survival in the PHP arm was 298 days, compared to median overall survival of 124 days for those patients in the BAC arm that did not crossover.

The hepatic response rate in the PHP arm was 34.1% compared to 2% for the BAC arm and 22.2% for patients who crossed-over to receive PHP upon progression of their tumors.  52.3% of patients in the PHP arm achieved stable disease, compared with 26.5% in the BAC group, and 40.7% in the crossover group.

"We are obviously very pleased with these results," said Eamonn P. Hobbs, President and CEO of Delcath. "This study supports our belief that chemosaturation via PHP has potential life-extending benefits as a treatment for patients suffering with terminal, metastatic disease in the liver.  Our rolling submission to the FDA is underway, and we are extremely excited by the future of this promising new treatment."

The data presented by Dr. Pingpank on June 5th are the result of the trial's Principal Investigator analysis and differ from results of the independent, blinded core lab analysis announced by Delcath on April 21, 2010.