Medarex Studying Ipilimumab As First-Line Treatment For Metastatic Melanoma
This article was originally published in The Pink Sheet Daily
Executive Summary
The registrational trial will compare patients treated with ipilimumab and decarbazine with decarbazine alone.
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Medarex plans to initiate a trial evaluating ipilimumab (MDX-010) in combination with chemotherapy as a first-line treatment for metastatic melanoma, the company said June 19. The study, which will commence "shortly," joins two other registrational trials underway evaluating the fully human antibody as a second-line therapy for the disease. Medarex is developing ipilimumab with Bristol-Myers Squibb. The randomized, double-blind, two-arm study will enroll 500 patients with previously untreated Stage III or Stage IV melanoma who will receive ipilimumab with decarbazine or decarbazine alone every three weeks for up to four doses. Patients without disease progression at week 24 will continue a maintenance phase; those patients will be treated with a single dose of ipilimumab every 12 weeks until disease progression. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, progression-free survival at week 12 and disease control rate. Medarex announced that it was initiating a trial evaluating ipilimumab as a second-line monotherapy March 31. The company expects to complete the trial this year and file a BLA for the indication sometime next year. The monotherapy trial also received a Special Protocol Assessment from FDA. Medarex is also investigating ipilimumab in combination with MDX-1379, a melanoma peptide vaccine, currently in Phase III. At the American Society of Clinical Oncology Annual Meeting in early June, Medarex presented promising data from the interim results of a Phase II study of the MDX-010 and MDX-1379 combination as an extended-dose treatment in adjuvant melanoma patients. -Jonathan Block |