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Bending the Curve Trial by Trial
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CheckMate 017

Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer after first-line chemotherapy

Phase 3N = 272NCT01642004

Population
Advanced squamous-cell NSCLC with disease progression during or after first-line 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 = 135): Nivolumab 3 mg per kilogram every 2 weeks
  • Docetaxel (control, n = 137): Docetaxel 75 mg per square metre every 3 weeks
People
Brahmer J
OSHR 0.59 (95% CI 0.44–0.79)Δ median OS+3.2 monthsΔ 12-month OS+18 pointsPFSHR 0.62 (95% CI 0.47–0.81)Δ median PFS+0.7 monthsΔ ORR+11 points
Show the numbers
Results reported for CheckMate 017
EndpointAnalysisNivolumabDocetaxelEffect
OSinterimBrahmer 2015median 9.2 months (7.3–13.3); 42% at 12 mo (34–50%)median 6 months (5.1–7.3); 24% at 12 mo (17–31%)HR 0.59 (95% CI 0.44–0.79)P<0.001Primary endpoint, analysed at the prespecified interim analysis. Grade 3 or 4 treatment-related adverse events: 7% vs 55%. The abstract states PD-L1 expression was neither prognostic nor predictive of benefit.
PFSinterimBrahmer 2015median 3.5 monthsmedian 2.8 monthsHR 0.62 (95% CI 0.47–0.81)P<0.001Secondary endpoint; the abstract gives no confidence intervals for the medians.
ORRinterimBrahmer 201520%9%P=0.008
Results reported for CheckMate 017
EndpointAnalysisNivolumabDocetaxelEffect
OSinterimBrahmer 2015median 9.2 months (7.3–13.3); 42% at 12 mo (34–50%)median 6 months (5.1–7.3); 24% at 12 mo (17–31%)HR 0.59 (95% CI 0.44–0.79)P<0.001Primary endpoint, analysed at the prespecified interim analysis. Grade 3 or 4 treatment-related adverse events: 7% vs 55%. The abstract states PD-L1 expression was neither prognostic nor predictive of benefit.
PFSinterimBrahmer 2015median 3.5 monthsmedian 2.8 monthsHR 0.62 (95% CI 0.47–0.81)P<0.001Secondary endpoint; the abstract gives no confidence intervals for the medians.
ORRinterimBrahmer 201520%9%P=0.008
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.590.44–0.79
PFS0.620.47–0.81
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%05101520Months (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%
663.6%50.0%
1240.5%25.0%
1727.8%14.0%
2317.7%7.0%
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%02468Months (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%
267.3%61.0%
445.3%37.1%
725.0%17.7%
916.8%10.8%
Primary publication: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(2):123-35. PubMedDOI

Appears in

Sources

  1. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(2):123-35.

    PubMedDOI