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Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non–Small-Cell Lung Cancer: CheckMate 153

In the November 20, 2020 edition of Journal of Clinical Oncology, David M. Waterhouse and colleagues report on the Long-term outcomes of the CheckMate 153 trial.

BACKGROUND

Investigators performed an exploratory analysis of the clinical trial CheckMate 153, to determine the utility of of 12 months fixed-duration versus continuous therapy with nivolumab has a phase 3B/4 study.

METHODS

Patients with previously treated non-small cell lung cancer, were treated with nivolumab (3 mg/kg every 2 weeks).  After 1 year of therapy, patients underwent radiographic imaging, and in those with stable disease, they were randomized to either continue treatment or observation until progression.  At progression, they were retreated with nivolumab 3 mg/kg every 2 weeks.

RESULTS

252 patients were randomized to continuous (n = 127) or 1-year fixed-duration (n = 125) treatment.  The initial study had started with 1,428 patients. 89 and 85 patients in the continuous and 1-year fixed-duration arms, respectively, had not progressed (This was defined as a progression free arm). The median PFS was longer with continuous versus 1-year fixed-duration treatment (PFS : 24.7 months v 9.4 months; HR, 0.56 [95% CI, 0.37 – 0.84]).  The median OS from random assignment was longer with continuous versus 1-year fixed-duration treatment than the progression free arm (not reached v 32.5 months; HR, 0.61 [95% CI, 0.37 – 0.99]) and ITT (not reached v 28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations.  The investigators reported no new safety signals.

The authors concluded “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.”

Reference:

Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non–Small-Cell Lung Cancer: CheckMate 153

https://ascopubs.org/doi/full/10.1200/JCO.20.00131

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