Melanoma drug trial stopped early after positive results
- Btistol-Myers Squibb stopped a phase III study of nivolumab versus dacarbazine early, because of superior overall survival in nivolumab-treated patients with advanced melanoma.
- Dacarbazine-treated patients will be crossed over to treatment with nivolumab.
- Nivolumabis a PD-1 checkpoint inhibitor and part of an emerging class of immune-oncologic drugs.
The clinical development program for nivolumab is extensive and includes more than 35 trials in 7,000 patients worldwide. Nivolumab is being evaluated both as monotherapy and as part of various combination regimens.
The study that was just halted---Checkmate-066—was a phase III, double-blind study of patients with previously untreated BRAF wild-type unresectable stage III and stage IV melanoma. Advanced melanoma is particularly difficult to treat. In late stages, the survival rate averages six months, with a one-year mortality rate of 75%. Results of this study were greeted with enthusiasm by the medical community, as well as shareholders.