ASH 2021: Bispecific Antibody Teclistamab in Early-Phase Myeloma Study
Posted: Monday, December 20, 2021
Teclistamab, a T-cell–redirecting IgG4 antibody targeting B-cell maturation antigen and CD3 receptors, seemed to produce responses in patients with multiple myeloma, with a manageable safety profile. Philippe Moreau, MD, PhD, of the University Hospital Hôtel-Dieu Nantes, France, presented these updated results of the MajesTEC-1 trial at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 896).
This trial enrolled 159 patients with multiple myeloma that relapsed or was refractory after 3 or more lines of therapy including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. Patients were treated with the recommended phase II dose: step-up doses of 60 and 300 µg/kg of teclistamab, followed by 1,500 µg/kg of weekly subcutaneous teclistamab. The responses were investigator-assessed according to the International Myeloma Working Group criteria.
After a median of 8.2 months of follow-up at the data cutoff, the objective response rate among the 40 patients treated during phase I of the study was 65%, and the complete or better response rate was 40%. Of the 26 patients who responded to therapy, 85% (22 patients) remain on treatment, including 1 patient who has had 15.2 months of follow-up. Responses deepened over time, the investigators reported, and no additional responders experienced progression of their disease. The rate of 6-month duration of response is 90%, although the median duration of response has not been reached. Pharmacodynamic data suggest that teclistamab may induce proinflammatory cytokines and T-cell activation, consistent with its mechanism of action.
There were no new safety signals identified at the time of data cutoff. The most common nonhematologic adverse events of any grade included cytokine-release syndrome (67%), injection-site erythema (23%), and fatigue (22%). In addition, 45% of patients had grade 3 or 4 neutropenia, 27% had grade 3 or 4 anemia, and 18% experienced grade 3 or 4 thrombocytopenia.
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