Dr. Wolchok on Ipilimumab After Complete Resection of Stage III Melanoma
Jedd D. Wolchok, MD, PhD, medical oncologist, Memorial Sloan Kettering Cancer Center, Giant of Cancer Care, discusses the initial efficacy and safety results from the EORTC 18071 phase III trial, which looked at ipilimumab versus placebo after complete resection of stage III melanoma.
Based on the initial success of ipilimumab in the metastatic melanoma setting, researchers began thinking of introducing the drug to patients who have a high risk of recurrence after surgery, Wolchok says.
In this study, over 900 patients were randomized to ipilimumab or placebo. Wolchok says the trial met its primary endpoint of achieving an improvement in relapse-free survival [HR=.75], which is a 9-month improvement in relapse-free survival compared to placebo. Although there were a significant amount of side effects, Wolchok says, this was expected.
With these results, Wolchok believes further discussion is needed to work out how to introduce this drug into the adjuvant setting. The adjuvant setting is a very heterogeneous group of patients with some patients having only a 30-40% risk of recurrence while others have a 90% or greater risk of recurrence. The side effect profile of ipilimumab warrants caution as to which group of patients receives this treatment, Wolchok says.
Wolchok also points out that this study used a dose and schedule of ipilimumab that is different from the FDA-approved dose and schedule in the metastatic setting.