TY - JOUR
T1 - Continuous versus 1-year fixed-duration nivolumab in previously treated advanced non-small-cell lung cancer
T2 - CheckMate 153
AU - Waterhouse, David M.
AU - Garon, Edward B.
AU - Chandler, Jason
AU - McCleod, Michael
AU - Hussein, Maen
AU - Jotte, Robert
AU - Horn, Leora
AU - Daniel, Davey B.
AU - Keogh, George
AU - Creelan, Ben
AU - Einhorn, Lawrence H.
AU - Baker, Justin
AU - Kasbari, Samer
AU - Nikolinakos, Petros
AU - Babu, Sunil
AU - Couture, Felix
AU - Leighl, Natasha B.
AU - Reynolds, Craig
AU - Blumenschein, George
AU - Gunuganti, Vijay
AU - Li, Ang
AU - Aanur, Nivedita
AU - Spigel, David R.
N1 - Funding Information:
Supported by Bristol Myers Squibb Company and Ono Pharmaceutical.
Publisher Copyright:
© 2020 by American Society of Clinical Oncology
PY - 2020/11/20
Y1 - 2020/11/20
N2 - PURPOSE Limited data exist on the optimal duration of immunotherapy, including for non-small-cell lung cancer (NSCLC). We present an exploratory analysis of CheckMate 153, a largely community-based phase IIIb/IV study, to evaluate the impact of 1-year fixed-duration versus continuous therapy on the efficacy and safety of nivolumab. METHODS Patients with previously treated advanced NSCLC received nivolumab monotherapy (3 mg/kg every 2 weeks). Those still receiving treatment at 1 year, including patients perceived to be deriving benefit despite radiographic progression, were randomly assigned to continue nivolumab until disease progression or unacceptable toxicity or to stop nivolumab with the option of on-study retreatment after disease progression (1-year fixed duration). RESULTS Of 1,428 patients treated, 252 were randomly assigned to continuous (n 5 127) or 1-year fixed-duration (n 5 125) treatment (intent-to-treat [ITT] population). Of these, 89 and 85 patients in the continuous and 1-year fixed-duration arms, respectively, had not progressed (progression-free survival [PFS] population). With minimum post-random assignment follow-up of 13.5 months, median PFS was longer with continuous versus 1-year fixed-duration treatment (PFS population: 24.7 months v 9.4 months; hazard ratio [HR], 0.56 [95% CI, 0.37 to 0.84]). Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached v 32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached v 28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations. Few new-onset treatment-related adverse events occurred. No new safety signals were identified. CONCLUSION To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous versus fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.
AB - PURPOSE Limited data exist on the optimal duration of immunotherapy, including for non-small-cell lung cancer (NSCLC). We present an exploratory analysis of CheckMate 153, a largely community-based phase IIIb/IV study, to evaluate the impact of 1-year fixed-duration versus continuous therapy on the efficacy and safety of nivolumab. METHODS Patients with previously treated advanced NSCLC received nivolumab monotherapy (3 mg/kg every 2 weeks). Those still receiving treatment at 1 year, including patients perceived to be deriving benefit despite radiographic progression, were randomly assigned to continue nivolumab until disease progression or unacceptable toxicity or to stop nivolumab with the option of on-study retreatment after disease progression (1-year fixed duration). RESULTS Of 1,428 patients treated, 252 were randomly assigned to continuous (n 5 127) or 1-year fixed-duration (n 5 125) treatment (intent-to-treat [ITT] population). Of these, 89 and 85 patients in the continuous and 1-year fixed-duration arms, respectively, had not progressed (progression-free survival [PFS] population). With minimum post-random assignment follow-up of 13.5 months, median PFS was longer with continuous versus 1-year fixed-duration treatment (PFS population: 24.7 months v 9.4 months; hazard ratio [HR], 0.56 [95% CI, 0.37 to 0.84]). Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached v 32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached v 28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations. Few new-onset treatment-related adverse events occurred. No new safety signals were identified. CONCLUSION To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous versus fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.
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U2 - 10.1200/JCO.20.00131
DO - 10.1200/JCO.20.00131
M3 - Article
C2 - 32910710
AN - SCOPUS:85096365101
SN - 0732-183X
VL - 38
SP - 3863
EP - 3873
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -