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Bending the Curve Trial by Trial
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CheckMate 057

Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer after platinum-based doublet chemotherapy

Phase 3N = 582NCT01673867

Population
Nonsquamous NSCLC that had progressed during or after platinum-based doublet chemotherapy
Design
Randomised, open-label, international phase 3 trial. Nivolumab 3 mg per kilogram every 2 weeks or docetaxel 75 mg per square metre every 3 weeks.
Primary endpoint
OS
Arms
  • Nivolumab (experimental, n = 292): Nivolumab 3 mg per kilogram every 2 weeks
  • Docetaxel (control, n = 290): Docetaxel 75 mg per square metre every 3 weeks
People
Borghaei H
OSHR 0.73Δ median OS+2.8 monthsΔ 12-month OS+12 pointsΔ median PFS−1.9 monthsΔ 12-month PFS+11 pointsΔ ORR+7 points
Show the numbers
Results reported for CheckMate 057
EndpointAnalysisNivolumabDocetaxelEffect
OSRandomised patients (N = 582)interimBorghaei 2015median 12.2 months (9.7–15.0); 51% at 12 mo (45–56%); 39% at 18 mo (34–45%)median 9.4 months (8.1–10.7); 39% at 12 mo (33–45%); 23% at 18 mo (19–28%)HR 0.73P=0.002Primary endpoint, analysed at the interim analysis. The abstract reports the hazard ratio for death as 0.73 with a 96% CI of 0.59 to 0.89, so no ci95 is entered. The 18-month rates come from additional follow-up. Grade 3 or 4 treatment-related adverse events: 10% vs 54%.
PFSRandomised patients (N = 582)interimBorghaei 2015median 2.3 months; 19% at 12 momedian 4.2 months; 8% at 12 moThe abstract states PFS did not favour nivolumab over docetaxel by median, although the 1-year PFS rate was higher with nivolumab. It gives no hazard ratio or P value for PFS.
ORRRandomised patients (N = 582)interimBorghaei 201519%12%P=0.02
Results reported for CheckMate 057
EndpointAnalysisNivolumabDocetaxelEffect
OSRandomised patients (N = 582)interimBorghaei 2015median 12.2 months (9.7–15.0); 51% at 12 mo (45–56%); 39% at 18 mo (34–45%)median 9.4 months (8.1–10.7); 39% at 12 mo (33–45%); 23% at 18 mo (19–28%)HR 0.73P=0.002Primary endpoint, analysed at the interim analysis. The abstract reports the hazard ratio for death as 0.73 with a 96% CI of 0.59 to 0.89, so no ci95 is entered. The 18-month rates come from additional follow-up. Grade 3 or 4 treatment-related adverse events: 10% vs 54%.
PFSRandomised patients (N = 582)interimBorghaei 2015median 2.3 months; 19% at 12 momedian 4.2 months; 8% at 12 moThe abstract states PFS did not favour nivolumab over docetaxel by median, although the 1-year PFS rate was higher with nivolumab. It gives no hazard ratio or P value for PFS.
ORRRandomised patients (N = 582)interimBorghaei 201519%12%P=0.02
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%051015Months (modelled)
  • Nivolumab (experimental)
  • Docetaxel (control)
Data table (modelled values)
MonthsNivolumabDocetaxel
0100.0%100.0%
578.3%73.1%
1057.7%47.5%
1544.2%30.1%
1939.0%23.0%
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%0246810Months (modelled)
  • Nivolumab (experimental)
  • Docetaxel (control)

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

Data table (modelled values)
MonthsNivolumabDocetaxel
0100.0%100.0%
340.5%61.0%
522.2%43.8%
89.0%26.7%
113.6%16.3%
Primary publication: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(17):1627-39. PubMedDOI

Appears in

Sources

  1. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(17):1627-39.

    PubMedDOI