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Bending the Curve Trial by Trial
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MIRAGE

Marizomib for patients with newly diagnosed glioblastoma: a randomized phase 3 trial (EORTC 1709 / Canadian Cancer Trials Group CE.8)

Phase 3N = 749NCT03345095

Population
Adults over 18 with newly diagnosed glioblastoma and Karnofsky performance status over 70; 749 randomised (99.9% of the planned 750)
Design
Multicentre, randomised, controlled, open-label phase 3 superiority trial (82 institutions in Europe, Canada and the USA); 1:1 randomisation to marizomib plus temozolomide/radiotherapy followed by temozolomide, or to standard temozolomide/radiotherapy followed by temozolomide; primary objective overall survival in the whole population and in MGMT promoter-unmethylated tumours
Primary endpoint
OS
Arms
  • Marizomib plus standard treatment (experimental): Marizomib added to temozolomide/radiotherapy followed by temozolomide; schedule not given in the abstract
  • Standard treatment (control): Temozolomide/radiotherapy followed by temozolomide
People
Roth P
OSHR 1.04Δ median OS−0.5 monthsOSHR 1.13Δ median OS+0.6 monthsPFSHR 0.97Δ median PFS+0.3 months
Show the numbers
Results reported for MIRAGE
EndpointAnalysisMarizomib plus standard treatmentStandard treatmentEffect
OSRandomised patients (n=749); analysis population not stated in the abstractOverall survival in the whole population (primary objective)primaryRoth 2024median 16.5 monthsmedian 17 monthsHR 1.04P=.64Medians are given in the abstract as standard versus marizomib. The abstract gives no confidence interval and does not state the direction of the hazard ratio.
OSPatients with MGMT promoter-unmethylated tumoursOverall survival in MGMT promoter-unmethylated tumours (primary objective)primaryRoth 2024median 15.1 monthsmedian 14.5 monthsHR 1.13P=.27Medians are given in the abstract as standard versus marizomib. No confidence interval, and the direction of the hazard ratio is not stated.
PFSRandomised patients (n=749); analysis population not stated in the abstractProgression-free survivalprimaryRoth 2024median 6.3 monthsmedian 6 monthsHR 0.97P=.67Medians are given in the abstract as standard versus marizomib. No confidence interval, and the direction of the hazard ratio is not stated.
Results reported for MIRAGE
EndpointAnalysisMarizomib plus standard treatmentStandard treatmentEffect
OSRandomised patients (n=749); analysis population not stated in the abstractOverall survival in the whole population (primary objective)primaryRoth 2024median 16.5 monthsmedian 17 monthsHR 1.04P=.64Medians are given in the abstract as standard versus marizomib. The abstract gives no confidence interval and does not state the direction of the hazard ratio.
OSPatients with MGMT promoter-unmethylated tumoursOverall survival in MGMT promoter-unmethylated tumours (primary objective)primaryRoth 2024median 15.1 monthsmedian 14.5 monthsHR 1.13P=.27Medians are given in the abstract as standard versus marizomib. No confidence interval, and the direction of the hazard ratio is not stated.
PFSRandomised patients (n=749); analysis population not stated in the abstractProgression-free survivalprimaryRoth 2024median 6.3 monthsmedian 6 monthsHR 0.97P=.67Medians are given in the abstract as standard versus marizomib. No confidence interval, and the direction of the hazard ratio is not stated.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Standard treatment (control)
  • Marizomib plus standard treatment (experimental)

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

Data table (modelled values)
MonthsStandard treatmentMarizomib plus standard treatment
0100.0%100.0%
1163.9%63.0%
2142.5%41.4%
3227.1%26.1%
4317.3%16.4%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Standard treatment (control)
  • Marizomib plus standard treatment (experimental)

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

Data table (modelled values)
MonthsStandard treatmentMarizomib plus standard treatment
0100.0%100.0%
965.0%66.2%
1940.3%41.8%
2826.2%27.7%
3816.3%17.5%
Primary publication: Roth P, Gorlia T, Reijneveld JC, de Vos F, Idbaih A, Frenel JS, et al. Marizomib for patients with newly diagnosed glioblastoma: A randomized phase 3 trial. Neuro Oncol. 2024;26(9):1670-1682. PubMedDOI

Appears in

Sources

  1. Roth P, Gorlia T, Reijneveld JC, de Vos F, Idbaih A, Frenel JS, et al. Marizomib for patients with newly diagnosed glioblastoma: A randomized phase 3 trial. Neuro Oncol. 2024;26(9):1670-1682.

    PubMedDOI