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CheckMate 143

Effect of nivolumab vs bevacizumab in patients with recurrent glioblastoma: the CheckMate 143 phase 3 randomized clinical trial

Phase 3N = 369NCT02017717

Population
Patients with glioblastoma at first recurrence following standard radiation and temozolomide; 439 enrolled and 369 randomised (184 nivolumab, 185 bevacizumab)
Design
Open-label randomised phase 3 trial (1:1) of nivolumab 3 mg/kg versus bevacizumab 10 mg/kg every 2 weeks until confirmed progression, unacceptable toxicity or death, in glioblastoma at first recurrence after radiation and temozolomide; primary endpoint overall survival
Primary endpoint
OS
Arms
  • Nivolumab (experimental, n = 184): Nivolumab 3 mg/kg every 2 weeks
  • Bevacizumab (control, n = 185): Bevacizumab 10 mg/kg every 2 weeks
People
Reardon DA
OSHR 1.04 (95% CI 0.83–1.30)Δ median OS−0.2 monthsΔ 12-month OS0 pointsΔ ORR−15.3 points
Show the numbers
Results reported for CheckMate 143
EndpointAnalysisNivolumabBevacizumabEffect
OSRandomised patients (n=369); analysis population not stated in the abstractOverall survival (primary endpoint)primarymedian follow-up 9.5 monthsReardon 2020median 9.8 months (8.2–11.8); 42% at 12 momedian 10 months (9.0–11.8); 42% at 12 moHR 1.04 (95% CI 0.83–1.30)P=0.76The abstract states the primary endpoint was not met and median OS was comparable between groups. Data cutoff 20 January 2017.
ORRRandomised patients (n=369); analysis population not stated in the abstractObjective response rateprimaryReardon 20207.8% (4.1–13.3%)23.1% (16.7–30.5%)—
Results reported for CheckMate 143
EndpointAnalysisNivolumabBevacizumabEffect
OSRandomised patients (n=369); analysis population not stated in the abstractOverall survival (primary endpoint)primarymedian follow-up 9.5 monthsReardon 2020median 9.8 months (8.2–11.8); 42% at 12 momedian 10 months (9.0–11.8); 42% at 12 moHR 1.04 (95% CI 0.83–1.30)P=0.76The abstract states the primary endpoint was not met and median OS was comparable between groups. Data cutoff 20 January 2017.
ORRRandomised patients (n=369); analysis population not stated in the abstractObjective response rateprimaryReardon 20207.8% (4.1–13.3%)23.1% (16.7–30.5%)—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.040.83–1.3
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Nivolumab (experimental)
  • Bevacizumab (control)

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

Data table (modelled values)
MonthsNivolumabBevacizumab
0100.0%100.0%
665.4%66.0%
1339.9%40.6%
1926.1%26.8%
2517.1%17.7%
Primary publication: Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, et al. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020;6(7):1003-1010. PubMedDOI

Appears in

Sources

  1. Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, et al. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020;6(7):1003-1010.

    PubMedDOI