7-Year Follow-up of ABC Trial: Ipilimumab/Nivolumab vs Nivolumab Alone in Melanoma Brain Metastases
Source: The Asco Post, February 2025
As reported in The Lancet Oncology by Long et al, 7-year follow-up of the Australian phase II ABC trial showed continued benefit of ipilimumab/nivolumab vs nivolumab alone in patients with asymptomatic melanoma brain metastases.
Study Details
In the open-label multicenter study, 63 immunotherapy-naive patients with asymptomatic metastases and no prior brain-directed therapy were randomly assigned 5:4 to receive ipilimumab/nivolumab (n = 36) or nivolumab alone (n = 27). An additional 16 patients with previous brain-directed therapy, neurologic symptoms, or leptomeningeal disease were assigned to receive nivolumab alone. Patients in the combination group received four doses of ipilimumab at 3 mg/kg plus nivolumab at 1 mg/kg every 3 weeks over 12 weeks, followed by nivolumab at 3 mg/kg every 2 weeks. Patients in the nivolumab group and the nonrandomized group received nivolumab at 3 mg/kg every 2 weeks. Maintenance nivolumab was changed to 480 mg every 4 weeks in a protocol amendment. Treatment continued until disease progression or unacceptable toxicity.
Key Findings
Median follow-up was 7.6 years. Intracranial responses occurred in 51% of the combination group, 20% of the nivolumab-alone group, and 6% of the nonrandomized nivolumab group.
Intracranial progression-free survival at 7 years was 42% (95% confidence interval [CI] = 29%–63%) in the combination group, 15% (95% CI = 6%–39%) in the nivolumab group, and 6% (95% CI = 1%–42%) in the nonrandomized nivolumab group. Overall survival rate at 7 years was 48% (95% CI = 34%–68%), 26% (95% CI = 13%–51%), and 13% (95% CI = 3%–46%) in the three groups, respectively.