NEW YORK and STOCKHOLM, September 23, 2011 /PRNewswire/ --
March 2011 Data Confirm Strong Treatment Effect of Chemosaturation
Delcath Systems (NASDAQ: DCTH) announced today that James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine, will present updated investigator results from the Phase 3 randomized trial of Delcath's chemosaturation system with melphalan in patients with hepatic metastases from ocular or cutaneous melanoma.
Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will present the abstract (9304), "Percutaneous Hepatic Perfusion (PHP) vs. Best Alternative Care (BAC) for Patients with Melanoma Liver Metastases - Efficacy Update of the Phase 3 Trial," in the plenary session today at 11:15am CEST at the European Multidisciplinary Cancer Congress in Stockholm. These updated results include follow-up data from patients through March 2011, an additional 12 months of data maturation from when Dr. Pingpank first presented investigator data from this Phase 3 trial in June 2010, at the American Society of Clinical Oncology's Annual Meeting.
With respect to the study's primary endpoint of hepatic progression free survival ("hPFS"), the updated investigator-assessed results showed that patients in the chemosaturation arm demonstrated median hPFS of 8.0 months compared to 1.6 months in the BAC arm, a significant 6.4 month extension of hPFS (hazard ratio 0.35, p<0.0001). Median overall PFS in the chemosaturation arm was 6.7 months compared to 1.6 months in the BAC arm, an increase of 5.1 months (hazard ratio 0.36, p<0.0001).
As reported previously, the hepatic response rate in the chemosaturation arm was 34% compared to 2% for the BAC arm. In addition, 52% of patients in the chemosaturation arm achieved stable disease, compared with 27% in the BAC group, givin
|SOURCE Delcath Systems, Inc.|
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