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Nivolumab (an anti–programmed death-1 antibody) is an adjuvant standard of care for patients with high-risk resected melanoma, although a watch-and-wait strategy remains an option. In the absence of head-to-head evidence, an indirect treatment comparison (ITC) of adjuvant nivolumab versus placebo, the proxy for a watch-and-wait strategy, was conducted in patients with high-risk resected melanoma. An ITC using the Bucher method compared nivolumab with placebo using intention-to-treat population data from the phase III CheckMate 238 (nivolumab vs ipilimumab; minimum follow-up, 4 years; NCT02388906) and European Organisation for Research and Treatment of Cancer (EORTC) 18071 (ipilimumab vs placebo; minimum follow-up, ≈4.5 years; NCT00636168) trials. The end-points were recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and overall survival (OS). To account for cross-trial differences in staging and subsequent therapy, additional analyses examined patients with stage IIIB/IIIC disease and adjusted post-recurrence survival in EORTC 18071, respectively. Nivolumab versus placebo was associated with clinically meaningful improvements in RFS (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.42–0.68) and OS (HR, 0.63; 95% CI, 0.45–0.89). Nivolumab versus placebo was also associated with clinically meaningful improvements in RFS (HR, 0.53; 95% CI, 0.40–0.69), DMFS (HR, 0.62; 95% CI, 0.46–0.83) and OS (HR, 0.67; 95% CI, 0.47–0.97) in patients with stage IIIB/IIIC disease and in OS (HR, 0.65; 95% CI, 0.46–0.92) in the overall population after adjusting post-recurrence survival in EORTC 18071. This ITC shows that adjuvant nivolumab provides clinically meaningful improvements in RFS, DMFS and OS versus a watch-and-wait strategy in high-risk resected melanoma. • Nivolumab is an adjuvant treatment for patients with high-risk resected melanoma. • This indirect treatment comparison (ITC) compared adjuvant nivolumab with placebo. • Placebo was the proxy for a watch-and-wait strategy. • Data used in the ITC were from two phase III trials. • Adjuvant nivolumab improved efficacy versus placebo in high-risk resected melanoma. [ABSTRACT FROM AUTHOR]

Recent changes in the adjuvant treatment of melanoma have raised interest in confirming relapse-free survival (RFS) as a surrogate for overall survival (OS). We explore this issue with the meta-analytic framework, using individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial of ipilimumab and published results from other adjuvant trials. The individual patient data analysis results at a median follow-up of 5.3 years showed a strong association between RFS and OS at the patient level (ρ = 0.84; 95% confidence interval [CI]: 0.82–0.87) and a moderate association at the trial level (R2 = 0.59; 95% CI: 0.08–1.00). The trial-level association previously observed in interferon-based trials appeared to be maintained when the EORTC 18071 results were added to a regression analysis using published results from other trials. More data from adjuvant trials are required to confirm the strength of association between RFS and OS in this setting. • We explored relapse-free survival (RFS) as a surrogate for overall survival (OS). • We used data from the European Organisation for Research and Treatment of Cancer 18071 trial and published results from other trials. • We found a strong association between RFS and OS at the patient level. • We found a moderate association between RFS and OS at the trial level. • Our results are promising and require confirmation with a larger number of trials. [ABSTRACT FROM AUTHOR]