TY - JOUR
T1 - 3303 Efficacy and safety in key patient subgroups of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naïve patients with advanced melanoma (MEL) (CheckMate 067)
AU - Larkin, J.
AU - Chiarion-Sileni, V.
AU - Gonzalez, R.
AU - Grob, J.J.
AU - Cowey, C.L.
AU - Lao, C.D.
AU - Wagstaff, J.
AU - Hogg, D.
AU - Hill, A.
AU - Carlino, M.S.
AU - Wolter, P.
AU - Lebbé, C.
AU - Schachter, J.
AU - Thomas, L.
AU - Hassel, J.C.
AU - Lorigan, P.
AU - Walker, D.
AU - Jiang, J.
AU - Hodi, F.S.
AU - Wolchok, J.D.
N1 - Proffered Paper Session, Mo28Sep2015, 'Melanoma and Skin Cancer' session.
PY - 2015/9
Y1 - 2015/9
N2 - Aims: Phase III study CheckMate 067 reported improved progression-free survival (PFS) with NIVO + IPI vs IPI alone. Here, we report results of subgroup analyses in this trial. Methods: Treatment-naive MEL pts (N = 945) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + placebo (PBO), or NIVO + IPI (1 mg/ kg + 3 mg/kg Q3W X 4) followed by NIVO 3 mg/kg Q2W, or to IPI (3 mg/kg Q3W X 4) + PBO until disease progression or unacceptable toxicity. PFS, a co-primary endpoint, was evaluated in predefined subgroups. Results: In the total population, median PFS was 11.5 months for NIVO + IPI vs 2.9 months for IPI alone (hazard ratio [HR] vs IPI, 0.42; P <0.00001), and was 6.9 months for NIVO alone (HR vs IPI, 0.57; P <0.00001). Numerically longer PFS was observed with the combination vs NIVO or IPI alone in all predefined subgroups, including baseline lactate dehydrogenase >upper limit of normal (NIVO + IPI: 4.2 months [95% CI: 2.8-9.3] vs NIVO: 2.8 months [95% CI: 2.6-4.0] vs IPI: 2.6 months [95% CI: 2.6-2.8]) and age
AB - Aims: Phase III study CheckMate 067 reported improved progression-free survival (PFS) with NIVO + IPI vs IPI alone. Here, we report results of subgroup analyses in this trial. Methods: Treatment-naive MEL pts (N = 945) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + placebo (PBO), or NIVO + IPI (1 mg/ kg + 3 mg/kg Q3W X 4) followed by NIVO 3 mg/kg Q2W, or to IPI (3 mg/kg Q3W X 4) + PBO until disease progression or unacceptable toxicity. PFS, a co-primary endpoint, was evaluated in predefined subgroups. Results: In the total population, median PFS was 11.5 months for NIVO + IPI vs 2.9 months for IPI alone (hazard ratio [HR] vs IPI, 0.42; P <0.00001), and was 6.9 months for NIVO alone (HR vs IPI, 0.57; P <0.00001). Numerically longer PFS was observed with the combination vs NIVO or IPI alone in all predefined subgroups, including baseline lactate dehydrogenase >upper limit of normal (NIVO + IPI: 4.2 months [95% CI: 2.8-9.3] vs NIVO: 2.8 months [95% CI: 2.6-4.0] vs IPI: 2.6 months [95% CI: 2.6-2.8]) and age
UR - http://www.mendeley.com/research/3303-efficacy-safety-key-patient-subgroups-nivolumab-nivo-alone-combined-ipilimumab-ipi-versus-ipi-a
U2 - 10.1016/s0959-8049(16)31822-6
DO - 10.1016/s0959-8049(16)31822-6
M3 - Meeting Abstract
SN - 0959-8049
VL - 51
SP - S664-S665
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - Supplement 3
ER -
