Teclistamab Shows 71% Reduction in Disease Progression Risk in Second-Line Myeloma
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
The MajesTEC-9 study demonstrated a 71% reduction in the risk of disease progression or death with teclistamab compared to standard care in patients with relapsed or refractory multiple myeloma. The trial included patients treated after 1 to 3 prior lines of therapy and showed robust progression-free survival and overall survival gains.
The results support earlier use of teclistamab, a BCMA (B-cell maturation antigen)–targeting bispecific antibody, as a new standard of care. The findings complement data from MajesTEC-3, where teclistamab in combination with daratumumab, a CD38 antibody, also proved superior to standard of care and CAR (chimeric antigen receptor) T-cell therapy.
Both MajesTEC-9 and MajesTEC-3 studies have demonstrated efficacy in terms of progression-free survival and overall survival as early as the second line of treatment. MajesTEC-9 evaluated teclistamab as a monotherapy, while MajesTEC-3 assessed it in combination with daratumumab. The studies have differences in patient populations, particularly regarding exposure to previous agents such as daratumumab and lenalidomide, as well as refractoriness to these treatments.
The current approval for teclistamab is based on the MajesTEC-1 study. The MajesTEC-9 results will allow use of teclistamab in an earlier line of treatment compared to the current approval.
Teclistamab offers a highly effective treatment option with a well-established safety profile that has been confirmed throughout the studies. The drug is readily accessible to patients, allowing clinicians and patients to tailor treatment according to disease characteristics, patient preference, and access considerations.
Progress in the treatment of relapsed or refractory multiple myeloma has been rapid since the introduction of T-cell–redirecting immunotherapies. The identification of B-cell maturation antigen led to the approvals of three bispecific antibodies, two chimeric antigen receptor T-cell therapies, and an antibody drug conjugate. Talquetamab, a bispecific antibody that targets GPRC5D (a G protein–coupled receptor) on myeloma cells and CD3 on T cells, has also been approved.