Medarex gets MDX-010 SPA

MEDX received an SPA from FDA for a Phase III trial comparing MDX-010 plus MDX-1379 to MDX-010 alone and to MDX-1379 alone in 750 patients with late stage, unresectable metastatic melanoma who have failed first-line treatment. MDX-010 is a monoclonal antibody against CTLA-4, and MDX-1379 is a gp100 melanoma peptide vaccine.

The primary endpoint of the trial, on which a BLA will be based, is objective response rate. Secondary endpoints include disease progression and survival. The study is expected to begin next month. ...