🔎︎
Teclistamab as monotherapy outperformed two standard combination regimens in patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy, according to an interim analysis of the phase 3 MajesTEC-9 trial published in the New England Journal of Medicine by Cyrille Touzeau and colleagues.
Teclistamab is a bispecific antibody targeting B-cell maturation antigen and CD3. Its established role has been in heavily pretreated disease, and its efficacy as earlier-line monotherapy had not been established.
The international open-label trial randomized 593 patients between April 2023 and April 2025, with 296 assigned to teclistamab and 297 to the investigator's choice of pomalidomide, bortezomib, and dexamethasone, or carfilzomib and dexamethasone. All participants had received one, two, or three prior lines of therapy including an anti-CD38 monoclonal antibody and lenalidomide.
Delivery is not simple. Teclistamab was given subcutaneously in 28-day cycles beginning with two step-up doses of 0.06 and 0.3 mg/kg, followed by weekly doses of 1.5 mg/kg during cycles 1 and 2, then 3 mg/kg every 2 weeks during cycles 3 through 6, and 3 mg/kg every 4 weeks from cycle 7 onward. Antimicrobial prophylaxis and immune globulin replacement were recommended throughout.
At a median follow-up of 17.3 months, estimated 18-month progression-free survival was 69.8% with teclistamab compared with 26.9% in the comparator group (hazard ratio for disease progression or death, 0.29; 95% CI, 0.23-0.38; P < 0.001). Overall survival was also significantly improved. Grade 3 or 4 infections were common.
The authors concluded that among patients with one to three previous lines of therapy, teclistamab significantly improved both progression-free and overall survival compared with the comparator regimens, and that grade 3 or 4 infections were common. The trial was funded by Johnson & Johnson.
For practices and plans, the escalating dose schedule, the recommended antimicrobial prophylaxis, and the immune globulin replacement are not incidental details. They define the supportive care infrastructure a site needs before it can deliver this regimen, and they extend beyond the drug itself into monitoring, pharmacy, and site-of-care considerations that shape where a patient can actually receive treatment.
