Delcath Systems, Inc, a development stage, oncology-focused, specialty pharmaceutical and medical device company, announced that its phase-III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study’s primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis. Comparing treatment with the Delcath PHP System with melphalan to Best Alternative Care (BAC), based on independent core lab review of patient scans, the statistical analysis revealed that the PHP patients had a statistically significant longer median hPFS of 214 days compared to 70 days in the BAC arm (p=0.001). This reflects a 144-day prolongation of hPFS over that of BAC control arm, with less than half the risk of progression and/or death in the PHP group compared to the BAC group (Hazard Ratio = 0.46).
James F Pingpank, associate professor of Surgery at the University of Pittsburgh School of Medicine and a lead principal investigator of the phase-III trial, will present full trial data on June 5th at the American Society of Clinical Oncology’s (ASCO) 2010 Annual Meeting. The endpoints announced today are results of the independent core lab analysis, which will be submitted to support Delcath’s New Drug Application (NDA) for its drug and proprietary treatment system to the US Food and Drug Administration (FDA). Delcath expects to initiate its rolling NDA submission to the US FDA within the next 30 days.
“We believe that these data support that the Delcath PHP System may provide a significantly better treatment option for patients suffering from melanoma metastases in the liver,” said Eamonn P Hobbs, president and CEO of Delcath. “With the treatment arm having a median hPFS of more than three-fold that of the control arm, we easily exceeded our expectations of clinical trial success. This is a major step forward in our plan to introduce what we believe is an effective treatment for patients who currently have very few viable options.”
The Delcath PHP System is an investigational system which is comprised of the chemotherapeutic agent melphalan combined with a proprietary administration system.
Delcath Systems is a development stage, oncology focused, specialty pharmaceutical and medical device company.