TY - JOUR
T1 - Efficacy and safety of nivolumab (NIVO) in patients with advanced melanoma (MEL) and poor prognostic factors who progressed on or after ipilimumab (IPI): Results from a phase II study (CheckMate 172).
AU - Schadendorf, Dirk
AU - Ascierto, Paolo Antonio
AU - Haanen, John B. A. G.
AU - Espinosa, Enrique
AU - Demidov, Lev V.
AU - Garbe, Claus
AU - Lorigan, Paul
AU - Gogas, Helen
AU - Hoeller, Christoph
AU - Guren, Tormod Kyrre
AU - Rorive, Andree
AU - Rutkowski, Piotr
AU - Muñoz-Couselo, Eva
AU - Dummer, Reinhard
AU - Carneiro, Ana
AU - Hospers, Geke
AU - Grigoryeva, Elena Borisovna
AU - Bhore, Rafia
AU - Nathan, Paul
PY - 2018/9/6
Y1 - 2018/9/6
N2 - 9524Background: In the phase III CheckMate 037 study, NIVO improved the objective response rate and progression-free survival with less toxicity vs chemotherapy in patients (pts) with MEL who progressed after prior IPI treatment. We report the first efficacy and updated safety data from pts with MEL in CheckMate 172, including those with rare melanoma subtypes (uveal, mucosal), brain metastases, or an ECOG performance status (PS) of 2. Methods: In this ongoing phase II, single-arm, open-label, multicenter study, pts with MEL who progressed on or after IPI were treated with NIVO 3 mg/kg Q2W for up to 2 years until progression or unacceptable toxicity (NCT02156804). We report efficacy and updated safety data from 734 treated pts with ≥1 year of follow-up (database lock: November 2016). Results: Of 734 pts, 50% had LDH>ULN, 7% ECOG PS 2, 66% M1c disease, 15% a history of brain metastases, and 23% received ≥3 prior therapies. Overall, 593 pts (81%) received more than 4 doses of NIVO. Overall, response rate at...
AB - 9524Background: In the phase III CheckMate 037 study, NIVO improved the objective response rate and progression-free survival with less toxicity vs chemotherapy in patients (pts) with MEL who progressed after prior IPI treatment. We report the first efficacy and updated safety data from pts with MEL in CheckMate 172, including those with rare melanoma subtypes (uveal, mucosal), brain metastases, or an ECOG performance status (PS) of 2. Methods: In this ongoing phase II, single-arm, open-label, multicenter study, pts with MEL who progressed on or after IPI were treated with NIVO 3 mg/kg Q2W for up to 2 years until progression or unacceptable toxicity (NCT02156804). We report efficacy and updated safety data from 734 treated pts with ≥1 year of follow-up (database lock: November 2016). Results: Of 734 pts, 50% had LDH>ULN, 7% ECOG PS 2, 66% M1c disease, 15% a history of brain metastases, and 23% received ≥3 prior therapies. Overall, 593 pts (81%) received more than 4 doses of NIVO. Overall, response rate at...
U2 - 10.1200/jco.2017.35.15_suppl.9524
DO - 10.1200/jco.2017.35.15_suppl.9524
M3 - Meeting Abstract
SN - 0732-183X
VL - 35
SP - 9524
EP - 9524
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 15_suppl
ER -
