Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial
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Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma : Results From the Phase IIIb/IV CheckMate 511 Trial. / Lebbé, Celeste; Meyer, Nicolas; Mortier, Laurent; Marquez-Rodas, Ivan; Robert, Caroline; Rutkowski, Piotr; Menzies, Alexander M; Eigentler, Thomas; Ascierto, Paolo A; Smylie, Michael; Schadendorf, Dirk; Ajaz, Mazhar; Svane, Inge Marie; Gonzalez, Rene; Rollin, Linda; Lord-Bessen, Jennifer; Saci, Abdel; Grigoryeva, Elena; Pigozzo, Jacopo.
I: Journal of Clinical Oncology, Bind 37, Nr. 11, 2019, s. 867-875.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma
T2 - Results From the Phase IIIb/IV CheckMate 511 Trial
AU - Lebbé, Celeste
AU - Meyer, Nicolas
AU - Mortier, Laurent
AU - Marquez-Rodas, Ivan
AU - Robert, Caroline
AU - Rutkowski, Piotr
AU - Menzies, Alexander M
AU - Eigentler, Thomas
AU - Ascierto, Paolo A
AU - Smylie, Michael
AU - Schadendorf, Dirk
AU - Ajaz, Mazhar
AU - Svane, Inge Marie
AU - Gonzalez, Rene
AU - Rollin, Linda
AU - Lord-Bessen, Jennifer
AU - Saci, Abdel
AU - Grigoryeva, Elena
AU - Pigozzo, Jacopo
PY - 2019
Y1 - 2019
N2 - PURPOSE: Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb/IV study (CheckMate 511) to determine if nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) improves the safety profile of the combination.PATIENTS AND METHODS: Patients (N = 360) age 18 years or older with previously untreated, unresectable stage III or IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for four doses. After 6 weeks, all patients received NIVO 480 mg once every 4 weeks until disease progression or unacceptable toxicity. The primary end point was a comparison of the incidence of treatment-related grade 3 to 5 adverse events (AEs) between groups. Secondary end points included descriptive analyses of objective response rate, progression-free survival, and overall survival. The study was not designed to formally demonstrate noninferiority of NIVO3+IPI1 to NIVO1+IPI3 for efficacy end points.RESULTS: At a minimum follow-up of 12 months, incidence of treatment-related grade 3 to 5 AEs was 34% with NIVO3+IPI1 versus 48% with NIVO1+IPI3 ( P = .006). In descriptive analyses, objective response rate was 45.6% in the NIVO3+IPI1 group and 50.6% in the NIVO1+IPI3 group, with complete responses in 15.0% and 13.5% of patients, respectively. Median progression-free survival was 9.9 months in the NIVO3+IPI1 group and 8.9 months in the NIVO1+IPI3 group. Median overall survival was not reached in either group.CONCLUSION: The CheckMate 511 study met its primary end point, demonstrating a significantly lower incidence of treatment-related grade 3-5 AEs with NIVO3+IPI1 versus NIVO1+IPI3. Descriptive analyses showed that there were no meaningful differences between the groups for any efficacy end point, although longer follow up may help to better characterize efficacy outcomes.
AB - PURPOSE: Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb/IV study (CheckMate 511) to determine if nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) improves the safety profile of the combination.PATIENTS AND METHODS: Patients (N = 360) age 18 years or older with previously untreated, unresectable stage III or IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for four doses. After 6 weeks, all patients received NIVO 480 mg once every 4 weeks until disease progression or unacceptable toxicity. The primary end point was a comparison of the incidence of treatment-related grade 3 to 5 adverse events (AEs) between groups. Secondary end points included descriptive analyses of objective response rate, progression-free survival, and overall survival. The study was not designed to formally demonstrate noninferiority of NIVO3+IPI1 to NIVO1+IPI3 for efficacy end points.RESULTS: At a minimum follow-up of 12 months, incidence of treatment-related grade 3 to 5 AEs was 34% with NIVO3+IPI1 versus 48% with NIVO1+IPI3 ( P = .006). In descriptive analyses, objective response rate was 45.6% in the NIVO3+IPI1 group and 50.6% in the NIVO1+IPI3 group, with complete responses in 15.0% and 13.5% of patients, respectively. Median progression-free survival was 9.9 months in the NIVO3+IPI1 group and 8.9 months in the NIVO1+IPI3 group. Median overall survival was not reached in either group.CONCLUSION: The CheckMate 511 study met its primary end point, demonstrating a significantly lower incidence of treatment-related grade 3-5 AEs with NIVO3+IPI1 versus NIVO1+IPI3. Descriptive analyses showed that there were no meaningful differences between the groups for any efficacy end point, although longer follow up may help to better characterize efficacy outcomes.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents, Immunological/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols/administration & dosage
KW - Disease Progression
KW - Double-Blind Method
KW - Drug Administration Schedule
KW - Female
KW - Humans
KW - Ipilimumab/administration & dosage
KW - Male
KW - Melanoma/drug therapy
KW - Middle Aged
KW - Neoplasm Staging
KW - Nivolumab/administration & dosage
KW - Progression-Free Survival
KW - Skin Neoplasms/drug therapy
KW - Time Factors
KW - Young Adult
U2 - 10.1200/JCO.18.01998
DO - 10.1200/JCO.18.01998
M3 - Journal article
C2 - 30811280
VL - 37
SP - 867
EP - 875
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 11
ER -
ID: 236508638