biostudies-literatureUnknown8(1)Ascierto PAThis work was supported by Bristol-Myers Squibb (no grant number is applicable).<h4>Background</h4>We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.<h4>Methods</h4>This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.<h4>Results</h4>At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04).Journal for immunotherapy of cancere000391https://www.ebi.ac.uk/biostudies/studies/S-EPMC7279645biostudies-literatureOverall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.PMC7279645Grange FSchadendorf DChiarion-Sileni VLebbe CHamid OGarbe CSvane IMMcNeil CLoquai CHoeller CSimsek BThomas LPikiel JMortier LLiszkay GRutkowski PHosein FAscierto PABastholt LDreno BFerraresi VMaio MMackiewicz AGutzmer RGrob JJSmylie MNyakas MDel Vecchio MArance ARobert CfalseOverall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.<h4>Background</h4>We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.<h4>Methods</h4>This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.<h4>Results</h4>At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04).2020-01-01T00:00:00Z2020 Jun2026-06-08T06:50:29.452Z2026-06-08T03:14:34.109ZS-EPMC72796453250394610.1136/jitc-2019-000391