publication date: Oct. 20, 2017

Drugs and Targets

FDA Accepts BMS application for Opdivo for resected high-risk advanced melanoma

Bristol-Myers Squibb Co. said FDA has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

FDA has previously granted Breakthrough Therapy Designation for this application, which is the seventh indication for which Opdivo has received this designation.

The application is based on data from the ongoing phase III CheckMate -238 study, which evaluated Opdivo in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study, Opdivo 3 mg/kg met the primary endpoint by significantly decreasing the risk of disease recurrence compared to Yervoy (ipilimumab) 10 mg/kg, an FDA-approved treatment for stage III adjuvant melanoma.

The results of the study were recently presented at the European Society for Medical Oncology 2017 Congress and published simultaneously in the New England Journal of Medicine.

CheckMate -238 is an ongoing phase III, randomized double-blind study of Opdivo vs. Yervoy in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. The trial randomized 906 patients 1:1 to receive either Opdivo 3 mg/kg intravenously every two weeks or Yervoy 10 mg/kg IV every three weeks for four doses and then every 12 weeks starting at week 24.

Patients were treated until disease recurrence, unacceptable toxicity or consent withdrawal for up to one 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.

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