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
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
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. / Ascierto, Paolo Antonio; Del Vecchio, Michelle; Mackiewicz, Andrzej; Robert, Caroline; Chiarion-Sileni, Vanna; Arance, Ana; Lebbé, Céleste; Svane, Inge Marie; Mcneil, Catriona; Rutkowski, Piotr; Loquai, Carmen; Mortier, Laurent; Hamid, Omid; Bastholt, Lars; Dreno, Brigitte; Schadendorf, Dirk; Garbe, Claus; Nyakas, Marta; Grob, Jean Jacques; Thomas, Luc; Liszkay, Gabriella; Smylie, Michael; Hoeller, Christoph; Ferraresi, Virginia; Grange, Florent; Gutzmer, Ralf; Pikiel, Joanna; Hosein, Fareeda; Simsek, Burcin; Maio, Michele.
In: Journal for ImmunoTherapy of Cancer, Vol. 8, No. 1, e000391, 2020.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - 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
AU - Ascierto, Paolo Antonio
AU - Del Vecchio, Michelle
AU - Mackiewicz, Andrzej
AU - Robert, Caroline
AU - Chiarion-Sileni, Vanna
AU - Arance, Ana
AU - Lebbé, Céleste
AU - Svane, Inge Marie
AU - Mcneil, Catriona
AU - Rutkowski, Piotr
AU - Loquai, Carmen
AU - Mortier, Laurent
AU - Hamid, Omid
AU - Bastholt, Lars
AU - Dreno, Brigitte
AU - Schadendorf, Dirk
AU - Garbe, Claus
AU - Nyakas, Marta
AU - Grob, Jean Jacques
AU - Thomas, Luc
AU - Liszkay, Gabriella
AU - Smylie, Michael
AU - Hoeller, Christoph
AU - Ferraresi, Virginia
AU - Grange, Florent
AU - Gutzmer, Ralf
AU - Pikiel, Joanna
AU - Hosein, Fareeda
AU - Simsek, Burcin
AU - Maio, Michele
PY - 2020
Y1 - 2020
N2 - 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. Trial registration number NCT01515189.
AB - 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. Trial registration number NCT01515189.
KW - immunology
KW - oncology
KW - randomized trials
U2 - 10.1136/jitc-2019-000391
DO - 10.1136/jitc-2019-000391
M3 - Journal article
C2 - 32503946
AN - SCOPUS:85086051365
VL - 8
JO - Journal for ImmunoTherapy of Cancer
JF - Journal for ImmunoTherapy of Cancer
SN - 2051-1426
IS - 1
M1 - e000391
ER -
ID: 258770576