In an analysis of two clinical trials reported in the Journal of Clinical Oncology, Weber et al identified “cure rates” with adjuvant nivolumab, ipilimumab, and placebo in patients with resected stage III/IV melanoma.
Study Details
The analysis used mixture cure models (MCMs) to estimate cure rates among patients receiving nivolumab or ipilimumab in the phase III CheckMate 238 trial and ipilimumab or placebo in the phase III EORTC 18071 trial. The MCMs were applied to patient-level recurrence-free survival data from the two trials. Cured patients were assumed to experience no disease recurrence and had mortality risks similar to those of the general population; uncured patients were at risk of disease recurrence and all-cause death.
Key Findings
Minimum follow-up in the CheckMate 238 population was 5 years. Median follow-up in the EORTC 18071 population was 6.9 years.
In CheckMate 238, estimated cure rates were 48.3% (95% confidence interval [CI] = 41.8%–54.9%) with nivolumab and 38.2% (95% CI = 32.7%–44.1%) with ipilimumab. In EORTC 18071, estimated cure rates were 38.0% (95% CI = 32.1%–44.2%) with ipilimumab and 29.2% (95% CI = 24.4–34.6%) with placebo.
In an indirect comparison of the two trials, the likelihood of cure was significantly higher with nivolumab vs placebo (odds ratio [OR] = 2.33, 95% CI= 1.49–3.65). The likelihood of cure was significantly higher with ipilimumab vs placebo (OR = 1.55, 95% CI = 1.13–2.12).
The investigators concluded: “Analyses involving two large phase III trials investigating adjuvant [immuno-oncology] treatment for resected melanoma demonstrate higher cure rates for both [nivolumab and ipilimumab] than placebo, with [nivolumab] providing the highest cure rate. Similar cure rates were estimated for patients treated with [ipilimumab] in both trials, despite staging and dosing differences.”
Peter Mohr, MD, of Kliniken Buxtehude, Buxtehude, Germany, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
