Categorized | Melanoma News, Regulatory

Nivolumab Earns FDA Approval as Adjuvant Therapy for Melanoma Based on Checkmate-238 Trial

Source: Pharmacy Times, January 2018

According to the National Cancer Institute, about 2.2% of people will be diagnosed with melanoma at a point in their lifetime. For those requiring surgery, the goal of adjuvant therapy is to increase relapse-free survival. Considering that patients with resected stage IV melanoma are often excluded from phase 3 trials of adjuvant therapy, it is imperative that researchers conduct studies to address outcomes in this population.
CheckMate 238 is a randomized, double-blind, phase 3 trial assessing the use of nivolumab (Opdivo, Bristol-Myers Squibb Company), a CTLA-4 immune checkpoint inhibitor, versus ipilimumab (Yervoy, Bristol-Myers Squibb Company), a PD-1 inhibitor, in resected stage IIIB, IIIC, or IV melanoma. An interim analysis published in the New England Journal of Medicine reports the safety and efficacy data from the trial.
The trial included data from 130 centers in 25 countries. Patients were assigned in a 1:1 ratio to receive an IV infusion of nivolumab at 10 mg/kg every 2 weeks or ipilimumab at 10 mg/kg every 2 weeks for 4 doses and then every 12 weeks thereafter with corresponding matching placebo. This occurred for up to 1 year or until recurrence, unacceptable toxicity, or withdrawal of patient consent.
read the original full article