Medarex and BMS initiate melanoma trial

The open label, single-arm, monotherapy registrational clinical trial is expected to enroll approximately 150 patients with unresectable stage III or stage IV metastatic melanoma who have progressed after at least one prior regimen of another melanoma treatment.

Patients will receive a dose of 10mg/kg of ipilimumab once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression.

The study is designed to assess best objective response rate as the primary endpoint. Secondary endpoints include disease control rate, disease progression and survival data, as well as duration of best objective responses.

Medarex said that it anticipates patient enrollment at approximately 80 centers worldwide will be completed by year-end for a potential biologics license application (BLA) submission opportunity in 2007.

The trial was reviewed by the FDA under a special protocol assessment (SPA) agreement concerning the suitability of the trial design to support regulatory approval.

“We and our partner, Bristol-Myers Squibb, are committed to the rapid and strategic development of ipilimumab and are pleased with the initiation of this second-line ipilimumab registrational study for late stage metastatic melanoma,” said Donald Drakeman, president and CEO of Medarex. “With this monotherapy registrational trial, pending favorable results, we believe that we are well positioned to file the initial BLA application for market approval next year.”