The FDA has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab, a PD-1 immune checkpoint inhibitor, to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. BLA was previously granted for this application, which is the seventh indication for which nivolumab has received this designation.
The application is based on data from the ongoing phase III CheckMate 238 study, which evaluated nivolumab in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study, nivolumab 3 mg/kg met the primary endpoint by significantly decreasing the risk of disease recurrence compared to ipilimumab 10 mg/kg, an FDA-approved treatment for stage III adjuvant melanoma.
Patients were treated until disease recurrence, unacceptable toxicity, or consent withdrawal for up to 1 year. The primary endpoint is RFS defined as the time between randomization and the date of first recurrence or death. Secondary endpoints include overall survival, recurrence free survival by PD-L1 tumor expression, quality of life, and safety.
The results of the study were recently presented at the ESMO 2017 Congress and published simultaneously in the New England Journal of Medicine.