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ICARIA-MM

Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM)

Phase 3N = 307NCT02990338

Population
Relapsed and refractory myeloma after at least two previous lines including lenalidomide and a proteasome inhibitor; patients refractory to an anti-CD38 antibody were excluded.
Design
Randomised, multicentre, open-label phase 3 study at 102 hospitals in 24 countries: 307 patients were randomly assigned 1:1 to isatuximab 10 mg per kg plus pomalidomide and dexamethasone, or pomalidomide and dexamethasone. The primary end point was progression-free survival determined by an independent response committee in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Isatuximab + Pd (experimental, n = 154): Isatuximab 10 mg/kg with pomalidomide 4 mg and dexamethasone
  • Pd (control, n = 153): Pomalidomide 4 mg and dexamethasone
People
Attal M
PFSHR 0.596 (95% CI 0.44–0.81)Δ median PFS+5 months
Show the numbers
Results reported for ICARIA-MM
EndpointAnalysisIsatuximab + PdPdEffect
PFSITT population (307)primarymedian follow-up 11.6 monthsAttal 2019median 11.5 months (8.9–13.9)median 6.5 months (4.5–8.3)HR 0.596 (95% CI 0.44–0.81)P=0.001Independent response committee assessment. Infusion reactions occurred in 38% with isatuximab and 0 with control; fatal adverse events in 12 patients (8%) and 14 (9%).
Results reported for ICARIA-MM
EndpointAnalysisIsatuximab + PdPdEffect
PFSITT population (307)primarymedian follow-up 11.6 monthsAttal 2019median 11.5 months (8.9–13.9)median 6.5 months (4.5–8.3)HR 0.596 (95% CI 0.44–0.81)P=0.001Independent response committee assessment. Infusion reactions occurred in 38% with isatuximab and 0 with control; fatal adverse events in 12 patients (8%) and 14 (9%).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.5960.44–0.81
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Isatuximab + Pd (experimental)
  • Pd (control)

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

Data table (modelled values)
MonthsIsatuximab + PdPd
0100.0%100.0%
765.6%47.4%
1443.0%22.5%
2226.6%9.6%
2917.4%4.5%
Primary publication: Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. PubMedDOI

Appears in

Sources

  1. Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107.

    PubMedDOI