FDA approves Adjuvant Yervoy in melanoma based on results of EORTC trial 18071
Based on the results of EORTC trial 18071, the FDA expanded the approval of Yervoy (ipilimumab) in melanoma to include adjuvant treatment of patients with stage 3 melanoma at high risk of recurrence following complete resection.
EORTC Headquarters handled project management, data management, and analysis for this successful registration trial.
Results of this EORTC trial appeared earlier this year in The Lancet Oncology and showed that adjuvant Ipilimumab significantly improves recurrence-free survival in patients with completely resected stage III melanoma at high risk of disease recurrence, but that this treatment was also associated with a high rate of immune-related adverse events.
Ipilimumab had already been approved as a treatment for patients with advanced melanoma. The intention with this study was to assess Ipilimumab as an adjuvant treatment for patients with completely resected stage III melanoma at high risk of recurrence.
This marked both the first clinical trial of an approved drug with an effect on survival in advanced melanoma in the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant setting.
EORTC trial 18071 was coordinated by the EORTC Melanoma Group and conducted in 93 sites located in 19 countries: Australia, Austria, Belgium, Canada, Czech, Denmark, Finland, France, Germany, Italy, Norway, Poland, Russia, Spain, Sweden, Switzerland, The Netherlands, the United Kingdom, and the United States of America. This trial was fully supported by Bristol-Myers Squibb.