In an exploratory analysis of the phase IIIb/IV CheckMate 153 trial published in the Journal of Clinical Oncology, David M. Waterhouse, MD, MPH, and colleagues found that continuing nivolumab beyond 1 year of treatment vs stopping at 1 year of treatment was associated with better outcomes in patients with previously treated advanced non–small cell lung cancer (NSCLC).
David M. Waterhouse, MD, MPH
Study Details
In the study, patients with previously treated advanced or metastatic NSCLC received nivolumab at 3 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent, or for 1 year. Treatment beyond initial progressive disease was permitted for patients with investigator-assessed clinical benefit. Patients still receiving treatment at 1 year were randomly assigned irrespective of response status to continue nivolumab or to stop treatment (1-year fixed duration group), with the option of receiving nivolumab retreatment on-study after disease progression.
Key Findings
Of 1,428 patients who received nivolumab in the study, 252 (intent-to-treat population) were randomly assigned to continuous (n = 127) or 1-year fixed-duration treatment (n = 125). Of these, 89 and 85 patients, respectively, had not progressed at 1 year (progression-free survival population).
Minimum post–random assignment follow-up was 13.5 months. A total of 47 patients in the fixed-duration group had disease progression after random assignment, with 39 receiving retreatment with nivolumab. The median duration of treatment in the continuous group was 13.6 months.
“To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous vs fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.”— David M. Waterhouse, MD, MPH, and colleagues
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In the progression-free survival population, median progression-free survival was 24.7 months in the continuous group vs 9.4 months in the fixed-duration group (hazard ratio [HR] = 0.56, 95% confidence interval [CI] = 0.37–0.84). Rates at 1 and 2 years were 64.6% vs 44.0% and 51.9% vs 30.7%. Among the 62 vs 58 patients with objective response at random assignment, median progression-free survival was 31.0 months vs 10.6 months (HR = 0.46, 95% CI = 0.27–0.77).
In the intent-to-treat population, median overall survival was not reached vs 28.8 months (HR = 0.62, 95% CI = 0.42–0.92). Rates at 1 and 2 years were 82.9% vs 81.7% and 70.4% vs 56.8%.
In the progression-free survival population, median overall survival was not reached vs 32.5 months (HR = 0.61, 95% CI = 0.37–0.99). Rates at 1 and 2 years were 86.1% vs 82.0% and 73.4% vs 60.9%. Among patients with objective response at random assignment, median overall survival was not reached vs 33.5 months (HR = 0.50, 95% CI = 0.26–0.97).
Few new-onset treatment-related adverse events were observed, and no new safety signals were identified.
The investigators concluded, “To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous vs fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.”
Dr. Waterhouse, of the US Oncology Network/Oncology Hematology Care, Cincinnati, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Bristol Myers Squibb and Ono Pharmaceutical. For full disclosures of the study authors, visit ascopubs.org.
