Title :

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

Author(s) :

Ascierto, Paolo [Auteur]
del Vecchio, Michelle [Auteur]
IRCCS Istituto Nazionale dei Tumori [Milano]
Mackiewicz, Andrzej [Auteur]
Poznan University of Medical Sciences [Poland] [PUMS]
Robert, Caroline [Auteur]
Institut Gustave Roussy [IGR]
Université Paris-Sud - Paris 11 [UP11]
Oncologie dermatologique
Chiarion-Sileni, Vanna [Auteur]
Arance, Ana [Auteur]
Institut d'Investigacions Biomèdiques August Pi i Sunyer [IDIBAPS]
Lebbé, Céleste [Auteur]
CIC Saint Louis [CIC-1427]
Hopital Saint-Louis [AP-HP] [AP-HP]
Svane, Inge [Auteur]
Herlev and Gentofte Hospital
Copenhagen University Hospital
Mcneil, Catriona [Auteur]
Rutkowski, Piotr [Auteur]
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology [MCMCC]
Loquai, Carmen [Auteur]
University Medical Center [Mainz]
Mortier, Laurent [Auteur]
Thérapies Assistées par Lasers et Immunothérapies pour l'Oncologie - U 1189 [OncoThAI]
Hôpital Claude Huriez [Lille]
Hamid, Omid [Auteur]
Bastholt, Lars [Auteur]
Odense University Hospital [OUH]
Dreno, Brigitte [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Schadendorf, Dirk [Auteur]
University Hospital Essen [AöR]
German Cancer Consortium [Heidelberg] [DKTK]
Garbe, Claus [Auteur]
Eberhard Karls Universität Tübingen = University of Tübingen
Nyakas, Marta [Auteur]
Oslo University Hospital [Oslo]
Grob, Jean-Jacques [Auteur]
Aix Marseille Université [AMU]
Assistance Publique - Hôpitaux de Marseille [APHM]
Thomas, Luc [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Liszkay, Gabriella [Auteur]
National Institute of Oncology [Budapest, Hungary]
Smylie, Michael [Auteur]
Hoeller, Christoph [Auteur]
Medizinische Universität Wien = Medical University of Vienna
Ferraresi, Virginia [Auteur]
Grange, Florent [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Gutzmer, Ralf [Auteur]
Medizinische Hochschule Hannover = Hannover Medical School [MHH]
Pikiel, Joanna [Auteur]
Hosein, Fareeda [Auteur]
Bristol-Myers Squibb [Princeton]
Simsek, Burcin [Auteur]
Bristol-Myers Squibb [Princeton]
Maio, Michele [Auteur]
University Hospital of Siena

Journal title :

JOURNAL FOR IMMUNOTHERAPY OF CANCER

Pages :

e000391

Publisher :

BMJ Publishing Group

Publication date :

2020-06

ISSN :

2051-1426

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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.Show less >

Language :

Anglais

Popular science :

Non

Collections :

• Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189

Source :

Harvested from HAL