Overall 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 - Inserm - Institut national de la santé et de la recherche médicale Access content directly
Journal Articles Journal for Immunotherapy of Cancer Year : 2020

Overall 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

1 INT-FGP - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale [Naples, Italy]
2 IRCCS Istituto Nazionale dei Tumori [Milano]
3 PUMS - Poznan University of Medical Sciences [Poland]
4 IGR - Institut Gustave Roussy
5 UP11 - Université Paris-Sud - Paris 11
6 Oncologie dermatologique
7 Istituto Oncologico Veneto I.R.C.C.S. [Padova, Italy]
8 IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer
9 CIC-1427 - CIC Saint Louis
10 AP-HP - Hopital Saint-Louis [AP-HP]
11 Herlev and Gentofte Hospital
12 Copenhagen University Hospital
13 RPAH - Royal Prince Alfred Hospital [Camperdown, Australia]
14 MCMCC - Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
15 University Medical Center [Mainz]
16 ONCO-THAI - Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189
17 Hôpital Claude Huriez [Lille]
18 OUH - Odense University Hospital
19 CHU Nantes - Centre hospitalier universitaire de Nantes
20 University Hospital [Essen, Germany]
21 DKTK - German Cancer Consortium [Heidelberg]
22 Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen
23 Oslo University Hospital [Oslo]
24 AMU - Aix Marseille Université
25 APHM - Assistance Publique - Hôpitaux de Marseille
26 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
27 National Institute of Oncology [Budapest, Hungary]
28 Cross Cancer Institute [Edmonton, AB, Canada]
29 Medizinische Universität Wien = Medical University of Vienna
30 Regina Elena National Cancer Institute [Rome]
31 CHU Reims - Centre Hospitalier Universitaire de Reims
32 MHH - Medizinische Hochschule Hannover
33 Wojewodzkie Centrum Oncologii [Gdańsk, Poland]
34 Bristol-Myers Squibb [Princeton]
35 University Hospital of Siena
Omid Hamid
  • Function : Author


Background: 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. Methods: 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. Results: 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). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively. Conclusions: This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.
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Dates and versions

inserm-03709901 , version 1 (30-06-2022)



Paolo Antonio Ascierto, Michelle del Vecchio, Andrzej Mackiewicz, Caroline Robert, Vanna Chiarion-Sileni, et al.. Overall 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. Journal for Immunotherapy of Cancer, 2020, 8 (1), pp.e000391. ⟨10.1136/jitc-2019-000391⟩. ⟨inserm-03709901⟩
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