Shonali Midha, MD, discusses real-world data with teclistamab in patients with relapsed/refractory multiple myeloma.
Shonali Midha, MD, physician, Dana-Farber Cancer Institute, instructor in medicine, Harvard Medical School, discusses real-world data with teclistamab-cqyv (Tecvayli) in patients with relapsed/refractory multiple myeloma.
The FDA approved teclistamab in October 2022, becoming the first bispecific antibody to receive an indication in the treatment of patients with relapsed or refractory multiple myeloma following at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. The approval was based on data from the phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098), in which teclistamab led to an objective response rate of 61.8% (95% CI, 52.1%-70.9%) by independent review committee assessment.
This single-institution, retrospective analysis evaluated patients who had been treated with teclistamab at Dana-Farber Cancer Institute. To be eligible for inclusion patients had to have completed step-up dosing with the agent. Among 56 patients, the ORR was 53.6%, which is comparable to the ORR reported in the pivotal MajesTEC-1 trial, Midha says. However, patients who received prior treatment with BCMA-directed agents and those with extramedullary disease experienced much lower ORRs of 45% and 37.5%, respectively. Notably, 80% of patients included in the analysis would have been ineligible for enrollment in MajesTEC-1. In univariate analysis, Revised International Staging System III classification and ferritin levels greater than 5000 ng/mL. The identification of ferritin level above 5000 came as a surprise to investigators, Midha says, and may more of a reflection of the extent of disease at the time of treatment. Additionally, median progression-free survival was approximately 4.7 months, 4.0 months in patients with prior BCMA exposure and 4.8 months in patients with BCMA-naïve disease (P =.48), Midha says.
Regarding safety, more than half of patients (57.1%) experienced infectious complications; 48.4% were grade 3 or 4 events. Median onset was 31.5 days. No deaths due to treatment-related infectious complications were reported.