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Published on The Lancet the promising results of a phase I study with a bispecific antibody that binds the B-cell maturation antigen and CD3
Although myeloma patients have benefited substantially from several new therapies, there is still a substantial unmet need for treatments that can achieve deep and sustained responses when the disease is no longer responsive to standard therapy: it is therefore a very good news the publication in The Lancet of the promising results achieved with teclistamab in a phase I study, the first reporting of a T-cell–redirecting bispecific antibody for the treatment of patients with cancer.
Teclistamab is a bispecific antibody that binds the B-cell maturation antigen (BCMA, a protein involved in myeloma cell growth and survival) and CD3 to redirect T cells to multiple myeloma cells. The MajesTEC-1 open-label, single-arm, phase 1 study enrolled 157 patients with multiple myeloma who were relapsed, refractory, or intolerant to established therapies and who had received a median of six prior lines of therapy. Participants were randomized to receive teclistamab intravenously or subcutaneously in different doses: the primary outcome of the study was to identify the recommended phase II dose and characterize teclistamab safety and tolerability and efficacy where possible.
Teclistamab was well-tolerated and adverse events were generally mild and manageable; weekly dosing resulted in satisfactory treatment levels in the bloodstream. In 40 patients treated with the recommended phase II dose (1,500 micrograms /Kg subcutaneously weekly) the overall response rate was 65%, with 58% of patients achieving a very good partial response. 85% of respondents were alive and continuing treatment after 7 months’ median follow-up and consistent T-cell activation was reported. Authors say that teclistamab results, showing promising tolerability and efficacy, support further clinical development in patients with relapsed or refractory multiple myeloma.