Previously Untreated Advanced Melanoma: Addition of Bempegaldesleukin to Nivolumab
Source: The Asco Post, September 2023
In the phase III PIVOT IO 001 trial reported in the Journal of Clinical Oncology, Adi Diab, MD, and colleagues found that the addition of bempegaldesleukin, a pegylated interleukin-2 cytokine prodrug, to nivolumab did not improve treatment outcomes in previously untreated patients with advanced melanoma.
Study Details
In the open-label trial, 783 patients with stage III unresectable or stage IV melanoma from sites in 26 countries were randomly assigned between October 2018 and December 2021. They received either bempegaldesleukin at 0.006 mg/kg followed by nivolumab at 360 mg every 3 weeks (n = 391) or nivolumab alone at 360 mg every 3 weeks (n = 392). The primary endpoints of the trial were objective response rate (in the population of patients with ? 6 months follow-up) and progression-free survival on blinded independent central review and overall survival.
Response and Survival Outcomes
Objective response was observed in 75 (27.7%, 95% confidence interval [CI] = 22.4%–33.4%) of 271 patients in the bempegaldesleukin/nivolumab group vs 98 (36.0%, 95% CI = 30.3%–42.0%) of 272 in the nivolumab group (odds ratio = 0.66, 99.9% CI = 0.35–1.24, P = .0311). Complete response was observed in 8.1% vs 12.5% of patients. Median duration of response was 29.67 months (95% CI = 18.89 months to not reached) vs not reached (95% CI = 26.74 months to not reached).