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MajesTEC-3

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma (MajesTEC-3)

Phase 3N = 587NCT05083169

Population
Relapsed or refractory multiple myeloma after one to three previous lines of therapy.
Design
Phase 3 trial: 587 patients with one to three previous lines of therapy were randomly assigned to teclistamab-daratumumab or to daratumumab plus dexamethasone with the investigator's choice of pomalidomide (DPd) or bortezomib (DVd). The primary end point was progression-free survival assessed by an independent review committee.
Primary endpoint
PFS
Arms
  • Teclistamab + daratumumab (experimental, n = 291): Teclistamab with daratumumab
  • DPd or DVd (control, n = 296): Daratumumab and dexamethasone with the investigator's choice of pomalidomide (DPd) or bortezomib (DVd)
People
Costa LJ
PFSHR 0.17 (95% CI 0.12–0.23)Δ 36-month PFS+53.7 pointsΔ ORR+13.7 pointsΔ ≥CR rate+49.7 pointsΔ MRD+41.3 points
Show the numbers
Results reported for MajesTEC-3
EndpointAnalysisTeclistamab + daratumumabDPd or DVdEffect
PFSRandomised patients (587)primarymedian follow-up 34.5 monthsCosta 202683.4% at 3 y29.7% at 3 yHR 0.17 (95% CI 0.12–0.23)P<0.001The abstract gives the 34.5 months as 'a median of 34.5 months' without naming it as the median follow-up.
ORRRandomised patients (587)primaryCosta 202689%75.3%P<0.001
≥CR rateRandomised patients (587)primaryCosta 202681.8%32.1%P<0.001
MRDRandomised patients (587)primaryCosta 202658.4%17.1%P<0.001Serious adverse events occurred in 70.7% with teclistamab-daratumumab and 62.4% with control; death from adverse events in 7.1% and 5.9%.
Results reported for MajesTEC-3
EndpointAnalysisTeclistamab + daratumumabDPd or DVdEffect
PFSRandomised patients (587)primarymedian follow-up 34.5 monthsCosta 202683.4% at 3 y29.7% at 3 yHR 0.17 (95% CI 0.12–0.23)P<0.001The abstract gives the 34.5 months as 'a median of 34.5 months' without naming it as the median follow-up.
ORRRandomised patients (587)primaryCosta 202689%75.3%P<0.001
≥CR rateRandomised patients (587)primaryCosta 202681.8%32.1%P<0.001
MRDRandomised patients (587)primaryCosta 202658.4%17.1%P<0.001Serious adverse events occurred in 70.7% with teclistamab-daratumumab and 62.4% with control; death from adverse events in 7.1% and 5.9%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.170.12–0.23
Primary publication: Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026;394(8):739-752. PubMedDOI

Appears in

Sources

  1. Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026;394(8):739-752.

    PubMedDOI