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The first approved checkpoint inhibitor, ipilimumab, continues to maintain an important role in the treatment of patients with melanoma, even as the PD-1/PD-L1 inhibitors continue to generate excitement, explains Louis M. Weiner, MD. This role was further demonstrated by results from the phase III EORTC 18701 study, which demonstrated that adjuvant ipilimumab significantly improved recurrence-free survival (RFS) compared with placebo for patients with resected stage III node-positive melanoma.
In this study, ipilimumab was administered at 10 mg/kg. At a median follow-up of 2.7 years, RFS rates were 46.5% with ipilimumab versus 34.8% with placebo. The median RFS was 26.1 versus 17.1 months for ipilimumab and placebo, respectively (HR=0.75, P = .0013).
At this point, interferon and pegylated interferon are commonly utilized in the adjuvant setting for patients with stage III melanoma. However, Omid Hamid, MD, explains, these treatments have demonstrated minimal improvements in survival while inducing high-levels of toxicity.
The ongoing phase III ECOG 1609 trial is comparing two doses of ipilimumab to interferon for patients with stage III/IV melanoma, Hamid notes. In the study, patients will receive adjuvant ipilimumab at either 10 mg/kg or 3 mg/kg every 21 days for 4 cycles. This will be followed by a maintenance period, utilizing the same dose administered every 90 days for 4 cycles. This study will help determine the benefits, dose, and optimal duration of treatment for ipilimumab following surgery, notes Hamid.
As novel therapies continue to be developed, the current economic environment demands evidence demonstrating clinically meaningful improvements in outcome, notes Weiner. At this point, due to costs, these therapies, particularly PD-1/CTLA-4 combinations, are only being utilized within a clinical trial, notes Hamid.