First BCMA/CD3 dual antibodies approved by EU

On August 24, Johnson & Johnson/Janssen announced that the European Commission (EC) has granted conditional marketing approval for teclistamab, a BCMA/CD3 bispecific antibody, as a single agent for the treatment of relapsed or refractory multiple myeloma (r/r MM). Currently, teclistamab is the first BCMA/CD3 dual antibody approved worldwide.

BCMA, a member of the tumor necrosis factor receptor (TNF) superfamily, is highly expressed in cancer cells of MM patients, and CD3 is involved in activating the immune system to fight infection. teclistamab is an IgG4 dual antibody developed using Genmab DuoBody® technology that targets both T-cell CD3 and MM cell BCMA, redirecting CD3+ T cells Teclistamab has been granted Breakthrough Therapy status by the European Union.

This conditional marketing approval is based on positive results from the Phase I/II MajesTEC-1 studies (NCT03145181 and NCT04557098), which evaluated the safety and efficacy of teclistamab in adult RRMM patients. The trial enrolled 164 patients who had received a median of 5 lines of prior therapy, all of whom had received 3 lines of therapy. Patients received weekly subcutaneous injections of teclistamab at a dose of 1.5 mg/kg with escalating doses of 0.06 mg/kg and 0.3 mg/kg.

The results showed that patients achieved deep and durable remission with an ORR of 63% (104/165). Notably, 58.8% of patients achieved very good partial remission or better remission (≥VGPR) and 39.4% achieved very good complete remission (CR); median duration of remission was 18.4 months, median progression-free survival was 11.3 months, and median overall survival was 18.3 months.The results of the MajesTEC-1 study were also published in the New England Journal of Medicine.