Posted: Friday, December 9, 2022
A high rate of deep, durable responses in the phase II portion of MajesTEC-1, a phase I/II study of patients with relapsed or refractory multiple myeloma who have received at least three lines of therapy, demonstrated the activity of the T-cell–directing bispecific antibody teclistamab-cqyv, according to an article published in The New England Journal of Medicine. Philippe Moreau, MD, of University Hospital Hôtel-Dieu, Nantes, France, and colleagues noted that although treatment-related cytopenias and infections were common, there were few grade 3 and no grade 4 events. On October 25, 2022, teclistamab was granted accelerated approval by the U.S. Food and Drug Administration in the treatment of resistant myeloma.
Not only does teclistamab’s clinical activity compare favorably with that of existing therapies for these patients, but also the lower-grade profile of cytokine-release syndrome may facilitate its outpatient administration. Teclistamab targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells, the authors explained.
The 165 patients who received a weekly subcutaneous injection of teclistamab had triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Overall response was the primary endpoint, and with a median follow-up of 14.1 months, the overall response rate (including partial responses or better) was 63.0%, with 65 patients (39.4%) having a complete response or better. Further, 44 patients (26.7%) had no measurable residual disease (MRD), and the MRD negativity rate among the patients with a complete response or better was 46%.
The median duration of response and the median duration of progression-free survival were 18.4 months and 11.3 months, respectively, continued Dr. Moreau and co-investigators. In the study, teclistamab was dosed at 1.5 mg/kg of the patient’s body weight after administration of step-up doses of 0.06 mg/kg and 0.3 mg/kg.
Disclosure: The study authors’ disclosure information can be found at nejm.org.