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news.Delcath Systems, a development stage, oncology-focused, specialty pharmaceutical and medical device company, has reported that its Phase III National Cancer Institute (NCI) led multi-center clinical trial has successfully met 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.
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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 longer median hPFS of 214 days compared to 70 days in the BAC arm. 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 .
The clinical study tested the Delcath PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma. Patients in the Phase III trial were randomised into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP System or treatment with BAC.
The study was designed to evaluate the hPFS in each of the two study arms. Following guidelines established by FDA under a Special Protocol Assessment (SPA), patients were permitted to cross-over from the BAC arm to receive treatment with the Delcath PHP System at the time of disease progression.
Delcath Systems said that the endpoints announced are results of the independent core lab analysis, which are expected to be submitted to support Delcath’s New Drug Application (NDA) for its drug and proprietary treatment system to the FDA. Delcath expects to initiate its rolling NDA submission to the FDA within the next 30 days.
Eamonn Hobbs, president and CEO of Delicate, said: “We believe that these data support that the Delicate PHP System may provide a better treatment option for patients suffering from melanoma metastases in the liver.
“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.”