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MajesTEC-1

Teclistamab in Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

Phase 1/2N = 165NCT04557098NCT03145181

Population
Relapsed or refractory myeloma after at least three therapy lines including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody; 77.6% triple-class refractory, median of five previous lines.
Design
Phase 1-2 single-arm study. Patients received weekly subcutaneous teclistamab 1.5 mg per kg after step-up doses of 0.06 and 0.3 mg per kg. The primary end point of the phase 2 part was overall response (partial response or better). The paper lists NCT03145181 (phase 1) and NCT04557098 (phase 2).
Primary endpoint
ORR
Arms
  • Teclistamab 1.5 mg/kg weekly (experimental, n = 165): Teclistamab 1.5 mg/kg subcutaneously weekly after step-up doses
People
Moreau P
Show the numbers
Results reported for MajesTEC-1
EndpointAnalysisTeclistamab 1.5 mg/kg weeklyControlEffect
ORRTreated patients (165)primarymedian follow-up 14.1 monthsMoreau 202263%—Cytokine release syndrome occurred in 72.1% (grade 3, 0.6%; no grade 4); infections in 76.4% (grade 3 or 4, 44.8%); neurotoxic events in 14.5%, including ICANS in 3.0% (all grade 1 or 2).
≥CR rateTreated patients (165)primaryMoreau 202239.4%——
MRDTreated patients (165)primaryMoreau 202226.7%—The MRD-negativity rate among patients with a complete response or better was 46%.
DORTreated patients (165)primaryMoreau 2022median 18.4 months—95% CI 14.9 to not estimable (lower bound only, so no interval is recorded).
PFSTreated patients (165)primaryMoreau 2022median 11.3 months (8.8–17.1)——
Results reported for MajesTEC-1
EndpointAnalysisTeclistamab 1.5 mg/kg weeklyControlEffect
ORRTreated patients (165)primarymedian follow-up 14.1 monthsMoreau 202263%—Cytokine release syndrome occurred in 72.1% (grade 3, 0.6%; no grade 4); infections in 76.4% (grade 3 or 4, 44.8%); neurotoxic events in 14.5%, including ICANS in 3.0% (all grade 1 or 2).
≥CR rateTreated patients (165)primaryMoreau 202239.4%——
MRDTreated patients (165)primaryMoreau 202226.7%—The MRD-negativity rate among patients with a complete response or better was 46%.
DORTreated patients (165)primaryMoreau 2022median 18.4 months—95% CI 14.9 to not estimable (lower bound only, so no interval is recorded).
PFSTreated patients (165)primaryMoreau 2022median 11.3 months (8.8–17.1)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%010203040Months (modelled)
  • Teclistamab 1.5 mg/kg weekly (experimental)

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

Data table (modelled values)
MonthsTeclistamab 1.5 mg/kg weekly
0100.0%
1263.6%
2342.0%
3526.8%
4617.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Teclistamab 1.5 mg/kg weekly (experimental)

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

Data table (modelled values)
MonthsTeclistamab 1.5 mg/kg weekly
0100.0%
765.1%
1442.4%
2127.6%
2818.0%
Primary publication: Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):495-505. PubMedDOI

Appears in

Sources

  1. Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):495-505.

    PubMedDOI