6533b82efe1ef96bd1293282
RESEARCH PRODUCT
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
Vanna Chiarion-sileniCéleste LebbéCatriona M. McneilJoanna PikielJean-jacques GrobLuc ThomasLars BastholtAndrzej MackiewiczMichele MaioOmid HamidVirginia FerraresiMarta NyakasCaroline RobertMichelle Del VecchioBurcin SimsekMichael SmylieLaurent MortierDirk SchadendorfCarmen LoquaiInge Marie SvaneInge Marie SvaneAna AranceGabriella LiszkayFareeda HoseinPiotr RutkowskiPaolo A. AsciertoFlorent GrangeChristoph HoellerBrigitte DrénoRalf GutzmerClaus Garbesubject
Cancer Researchmedicine.medical_specialty2435[SDV]Life Sciences [q-bio]ImmunologyMedizinIpilimumabrandomized trialsGastroenterologyAsymptomaticlaw.inventionimmunology03 medical and health sciences0302 clinical medicineRandomized controlled triallawInternal medicinemedicineClinical endpointImmunology and Allergy1506030212 general & internal medicineAdverse effectRC254-282Clinical/Translational Cancer ImmunotherapyPharmacologybusiness.industryIncidence (epidemiology)MelanomaNeoplasms. Tumors. Oncology. Including cancer and carcinogensmedicine.diseaseimmunology; oncology; randomized trials[SDV] Life Sciences [q-bio]Oncology030220 oncology & carcinogenesisoncologyMolecular Medicinemedicine.symptombusinessBrain metastasismedicine.drugdescription
BackgroundWe 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.MethodsThis 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.ResultsAt 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 mutantBRAFtumors, 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.ConclusionsThis 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 numberNCT01515189.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-06-01 |