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Bending the Curve Trial by Trial
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AETHERA

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant (ASCT)

Phase 3N = 329NCT01100502

Population
Unfavourable-risk relapsed or primary refractory classic Hodgkin lymphoma after autologous stem-cell transplantation.
Design
Randomised, double-blind, placebo-controlled phase 3 trial at 78 sites in North America and Europe: brentuximab vedotin 1.8 mg per kilogram or placebo every 3 weeks for 16 cycles, starting 30 to 45 days after autologous stem-cell transplantation. Randomisation stratified by best clinical response to salvage chemotherapy and by primary refractory versus relapse timing. Primary endpoint: progression-free survival by independent review. Analysis by intention to treat.
Primary endpoint
PFS
Arms
  • Brentuximab vedotin (experimental, n = 165): Brentuximab vedotin 1.8 mg per kilogram every 3 weeks, 16 cycles
  • Placebo (control, n = 164): Placebo every 3 weeks, 16 cycles
People
Moskowitz CH
PFSHR 0.57 (95% CI 0.40–0.81)Δ median PFS+18.8 months
Show the numbers
Results reported for AETHERA
EndpointAnalysisBrentuximab vedotinPlaceboEffect
PFSprimaryMoskowitz 2015median 42.9 months (30.4–42.9)median 24.1 monthsHR 0.57 (95% CI 0.40–0.81)P=0.0013Progression-free survival by independent review. The 95% CI for median PFS in the placebo group is 11.5 months to not estimable, so its interval is not encoded here.
Results reported for AETHERA
EndpointAnalysisBrentuximab vedotinPlaceboEffect
PFSprimaryMoskowitz 2015median 42.9 months (30.4–42.9)median 24.1 monthsHR 0.57 (95% CI 0.40–0.81)P=0.0013Progression-free survival by independent review. The 95% CI for median PFS in the placebo group is 11.5 months to not estimable, so its interval is not encoded here.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.570.4–0.81
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Brentuximab vedotin (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsBrentuximab vedotinPlacebo
0100.0%100.0%
2764.6%46.0%
5441.8%21.2%
8027.5%10.0%
10717.7%4.6%
Primary publication: Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;385(9980):1853-62. PubMedDOI

Appears in

Sources

  1. Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;385(9980):1853-62.

    PubMedDOI