Posted: Friday, July 15, 2022
Updated efficacy and results with the bispecific antibody teclistamab from the multicohort, open-label, phase I/II MajesTEC-1 study in resistant multiple myeloma were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8007). According to Ajay K. Nooka, MD, of Winship Cancer Institute, Atlanta, and colleagues, the follow-up data “reaffirm the deep and durable responses” with this agent in this refractory setting, with no new safety considerations.
In phase I of this study, the recommended phase II dose of teclistamab was identified as a weekly subcutaneous dose of 1.5 mg/kg preceded by step-up doses of 0.06 and 0.3 mg/kg. Patients tested in phase I received no prior exposure to an anti–B-cell maturation antigen (BCMA)-targeted treatment, and the recommended dose was used for all phase II trials. The primary endpoint was overall response rate, which was assessed per International Myeloma Working Group 2016 criteria.
The investigators’ findings revealed an overall response rate of 64% (95% confidence interval [CI] = 56%–72%), with a complete response or better achieved in 30% of patients. The 12-month duration of response rate was 66% (95% CI = 49%–79%), and the majority of patients who responded to treatment in the first cycle had a reduction in soluble BCMA.
Assessments of adverse events revealed that the most common hematologic events were neutropenia (65%; grade 3 or 4: 57%), anemia (50%; grade 3 or 4: 35%), thrombocytopenia (38%; grade 3 or 4: 21%), and lymphopenia (34%; grade 3 or 4: 32%). The most common nonhematologic adverse event was cytokine-release syndrome (72%; grade 3: 0.6%; no grade 4 or 5). Overall, there were no treatment-related deaths, and no patients required a teclistamab dose reduction.
Disclosure: For full disclosure of the study authors, visit, coi.asco.org.