ESMO 2018: 4-Year Follow-up Confirms Benefit of Nivolumab in Advanced Melanoma
Posted: Friday, November 16, 2018
According to research presented at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract LBA44), both nivolumab alone and nivolumab plus ipilimumab continue to show a sustained overall survival benefit in patients with advanced melanoma. These findings, which represent 4-year follow-up data from the CheckMate 067 trial, were simultaneously published in The Lancet Oncology. Previously reported findings from this trial showed improvement in objective response, progression-free survival, and overall survival rates as well.
“The results of this analysis at 4 years of follow-up show that a durable, sustained survival benefit can be achieved with first-line nivolumab plus ipilimumab or nivolumab alone in patients with advanced melanoma,” noted F. S. Hodi, MD, of the Dana-Farber Cancer Institute, and colleagues.
This phase III trial enrolled 945 patients who had untreated, unresectable stage 3 or stage 4 melanoma. Participants were randomly asigned 1:1:1 to receive either intravenous nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg every 3 weeks for 12 weeks total, followed by nivolumab at 3 mg/kg every 2 weeks; nivolumab at 3 mg/kg every 2 weeks plus a placebo; or ipilimumab at 3 mg/kg every 3 weeks for 12 weeks total, plus a placebo.
At 4 years, the median overall survival was not reached in patients treated with nivolumab plus ipilimumab, 36.9 months in patients treated with nivolumab alone, and 19.9 months in those treated with ipilimumab alone. The median progression-free survival was 11.5 months with the combination therapy, 6.9 months with nivolumab alone, and 2.9 months with ipilimumab alone.
As for toxicity, 59% of patients undergoing combination treatment reported experiencing grade 3-4 adverse events, as did 22% of the nivolumab group and 28% of the ipilimumab group. Overall, 4 treatment-related deaths occurred, although none since the 3-year analysis.