RT Journal Article
T1 Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.
A1 Borghaei, Hossein
A1 Gettinger, Scott
A1 Vokes, Everett E
A1 Chow, Laura Q M
A1 Burgio, Marco Angelo
A1 de Castro Carpeno, Javier
A1 Pluzanski, Adam
A1 Arrieta, Oscar
A1 Frontera, Osvaldo Arén
A1 Chiari, Rita
A1 Butts, Charles
A1 Wójcik-Tomaszewska, Joanna
A1 Coudert, Bruno
A1 Garassino, Marina Chiara
A1 Ready, Neal
A1 Felip, Enriqueta
A1 García, Miriam Alonso
A1 Waterhouse, David
A1 Domine, Manuel
A1 Barlesi, Fabrice
A1 Antonia, Scott
A1 Wohlleber, Markus
A1 Gerber, David E
A1 Czyzewicz, Grzegorz
A1 Spigel, David R
A1 Crino, Lucio
A1 Eberhardt, Wilfried Enst Erich
A1 Li, Ang
A1 Marimuthu, Sathiya
A1 Brahmer, Julie
AB Immunotherapy has revolutionized the treatment of advanced non-small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials. Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated. After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3-5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs. At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC.
YR 2021
FD 2021-01-15
LK http://hdl.handle.net/10668/16983
UL http://hdl.handle.net/10668/16983
LA en
DS RISalud
RD Apr 9, 2025