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MajesTEC-9

Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy (MajesTEC-9)

Phase 3N = 593NCT05572515

Population
Relapsed or refractory multiple myeloma after one to three previous lines including an anti-CD38 monoclonal antibody and lenalidomide.
Design
Phase 3 trial: patients who had received one, two or three lines of therapy, including an anti-CD38 antibody and lenalidomide, were randomly assigned to teclistamab or to the investigator's choice of pomalidomide-bortezomib-dexamethasone (PVd) or carfilzomib-dexamethasone (Kd). Antimicrobial prophylaxis and immune globulin replacement were recommended. The primary end point was progression-free survival assessed by an independent review committee; results are from an interim analysis.
Primary endpoint
PFS
Arms
  • Teclistamab (experimental, n = 296): Teclistamab monotherapy
  • PVd or Kd (control, n = 297): Investigator's choice of pomalidomide-bortezomib-dexamethasone (PVd) or carfilzomib-dexamethasone (Kd)
People
Touzeau C
PFSHR 0.29 (95% CI 0.23–0.38)Δ 18-month PFS+42.9 pointsΔ ≥CR rate+49.1 pointsOSHR 0.60 (95% CI 0.43–0.83)Δ 18-month OS+10.6 points
Show the numbers
Results reported for MajesTEC-9
EndpointAnalysisTeclistamabPVd or KdEffect
PFSRandomised patients (593)interimmedian follow-up 17.3 monthsTouzeau 202669.8% at 18 mo26.9% at 18 moHR 0.29 (95% CI 0.23–0.38)P<0.001Grade 3 or 4 adverse events 84.9% versus 76.3%; grade 5 adverse events 6.5% versus 3.5%. Cytokine release syndrome, mostly grade 1 or 2, 66.0%; ICANS 4.1%; grade 3 or 4 infection 41.6% versus 29.0%.
≥CR rateRandomised patients (593)interimTouzeau 202665.9%16.8%P<0.001
OSRandomised patients (593)interimTouzeau 202679.2% at 18 mo68.6% at 18 moHR 0.60 (95% CI 0.43–0.83)P=0.002
Results reported for MajesTEC-9
EndpointAnalysisTeclistamabPVd or KdEffect
PFSRandomised patients (593)interimmedian follow-up 17.3 monthsTouzeau 202669.8% at 18 mo26.9% at 18 moHR 0.29 (95% CI 0.23–0.38)P<0.001Grade 3 or 4 adverse events 84.9% versus 76.3%; grade 5 adverse events 6.5% versus 3.5%. Cytokine release syndrome, mostly grade 1 or 2, 66.0%; ICANS 4.1%; grade 3 or 4 infection 41.6% versus 29.0%.
≥CR rateRandomised patients (593)interimTouzeau 202665.9%16.8%P<0.001
OSRandomised patients (593)interimTouzeau 202679.2% at 18 mo68.6% at 18 moHR 0.60 (95% CI 0.43–0.83)P=0.002
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.290.23–0.38
OS0.60.43–0.83
Primary publication: Touzeau C, Mina R, Quach H, Hungria V, Bhutani D, Chen W, et al. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026;395(5):440-453. PubMedDOI

Appears in

Sources

  1. Touzeau C, Mina R, Quach H, Hungria V, Bhutani D, Chen W, et al. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026;395(5):440-453.

    PubMedDOI