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CheckMate 577

Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer

Phase 3N = 794NCT02743494

Population
Adults with resected (R0) stage II or III oesophageal or gastro-oesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease
Design
Global, randomised (2:1), double-blind, placebo-controlled phase 3 trial. Nivolumab (240 mg every 2 weeks for 16 weeks, then 480 mg every 4 weeks) or matching placebo, for a maximum of 1 year. Primary endpoint disease-free survival. Median follow-up 24.4 months.
Primary endpoint
DFS
Arms
  • Nivolumab (experimental, n = 532): Nivolumab 240 mg every 2 weeks for 16 weeks, then 480 mg every 4 weeks, for up to 1 year
  • Placebo (control, n = 262): Matching placebo for up to 1 year
People
Kelly RJ
DFSHR 0.69Δ median DFS+11.4 months
Show the numbers
Results reported for CheckMate 577
EndpointAnalysisNivolumabPlaceboEffect
DFSPatients who received nivolumab (532) or placebo (262), as reported in the abstractprimarymedian follow-up 24.4 monthsKelly 2021median 22.4 months (16.6–34.0)median 11 months (8.3–14.3)HR 0.69P<0.001The abstract gives the hazard ratio for disease recurrence or death with a 96.4% confidence interval of 0.56 to 0.86, so no ci95 is entered. Grade 3 or 4 treatment-related adverse events: 13% (71 of 532) with nivolumab vs 6% (15 of 260) with placebo; discontinuation for treatment-related adverse events 9% vs 3%.
Results reported for CheckMate 577
EndpointAnalysisNivolumabPlaceboEffect
DFSPatients who received nivolumab (532) or placebo (262), as reported in the abstractprimarymedian follow-up 24.4 monthsKelly 2021median 22.4 months (16.6–34.0)median 11 months (8.3–14.3)HR 0.69P<0.001The abstract gives the hazard ratio for disease recurrence or death with a 96.4% confidence interval of 0.56 to 0.86, so no ci95 is entered. Grade 3 or 4 treatment-related adverse events: 13% (71 of 532) with nivolumab vs 6% (15 of 260) with placebo; discontinuation for treatment-related adverse events 9% vs 3%.
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Nivolumab (experimental)
  • Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNivolumabPlacebo
0100.0%100.0%
1464.8%41.4%
2842.0%17.1%
4227.3%7.1%
5617.7%2.9%
Primary publication: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021;384(13):1191-1203. PubMedDOI

Appears in

Sources

  1. Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021;384(13):1191-1203.

    PubMedDOI