02984nam a2200265   4500001000800000007000300008008004100011040000800052041000800060100003500068245008000103300002300183520214300206650003902349650002002388650001902408700002602427700002502453700002702478700002902505700002602534773011002560942003102670999001702701ESSALUDta      t        pe ||||| |||| 00| 0 spa d  aBMG  aspa  aTouzeau, CyrilleeAutor953813  aTeclistamab in multiple myeloma with one to three previous lines of therapy  apáginas: 440-453  aBackground: The efficacy of teclistamab, a bispecific antibody targeting B-cell maturation antigen and CD3, as early-line monotherapy in relapsed or refractory multiple myeloma is unclear.
Methods: We randomly assigned patients with relapsed or refractory multiple myeloma who had previously received one, two, or three lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide, to receive teclistamab or the investigator’s choice of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Antimicrobial prophylaxis and immune globulin replacement were recommended. The primary end point was progression-free survival as assessed by an independent review committee.
Results: A total of 296 patients were assigned to teclistamab and 297 to PVd or Kd. At the interim analysis (median follow-up, 17.3 months), teclistamab significantly improved progression-free survival as compared with PVd or Kd (estimated 18-month progression-free survival, 69.8% vs. 26.9%; hazard ratio for disease progression or death, 0.29; 95% confidence interval [CI], 0.23 to 0.38; P<0.001). The percentage of patients with a complete response or better was higher with teclistamab than with PVd or Kd (65.9% vs. 16.8%, P<0.001). Overall survival was improved with teclistamab as compared with PVd or Kd (estimated 18-month overall survival, 79.2% vs. 68.6%; hazard ratio for death, 0.60; 95% CI, 0.43 to 0.83; P=0.002). Adverse events of grade 3 or 4 occurred in 84.9% of teclistamab recipients and in 76.3% of PVd or Kd recipients, with grade 5 adverse events in 6.5% and 3.5%, respectively. Cytokine release syndrome, mostly of grade 1 or 2, occurred in 66.0% of teclistamab recipients, and immune effector cell–associated neurotoxicity syndrome occurred in 4.1%. Grade 3 or 4 infection occurred in 41.6% of teclistamab recipients and in 29.0% of PVd or Kd recipients. Conclusions: Among patients with multiple myeloma and one to three previous lines of therapy, teclistamab significantly improved progression-free and overall survival as compared with PVd or Kd. Infections of grade 3 or 4 were common.   aTRATAMIENTOS EN ONCOLOGÍA953734  aLEUCEMIA933873  aLINFOMA939360  aMina, Roberto 953814  aQuach, Hang  953815  aHungria, Vania 953816  aBhutani, Divaya  953817  aChen, Wenming 9538180 022717922638dMassachusetts NEJM GroupoNEJM005tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-07-31zSQB  c22751d22751