Dr Grajales-Cruz on Real-World Teclistamab Data in BCMA-Pretreated Multiple Myeloma

Ariel Grajales-Cruz, MD, assistant member, Department of Malignant Hematology, Multiple Myeloma Section, Moffitt Cancer Center; assistant professor, University of South Florida, discusses the rationale for a real-world study of teclistamab-cqyv (Tecvayli) in patients with relapsed/refractory multiple myeloma who had received prior BCMA-directed therapy.

Bispecific antibodies are an evolving treatment option for patients with relapsed/refractory multiple myeloma, Grajales-Cruz says. Historically, after patients progressed on standard therapies, they did not have many treatment options, Grajales-Cruz notes. However, 3 bispecific antibodies are now approved by the FDA for patients with relapsed/refractory multiple myeloma. Teclistamab, a dual BCMA- and CD3-directed agent, was FDA approved in 2022 for patients with relapsed/refractory disease who have received 4 or more prior lines of therapy, including a proteasome inhibitor (PI) an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. In August 2023, the FDA approved both the LAG-3 inhibitor elranatamab-bcmm (Elrexfio) and the GPRC5D-targeted bispecific antibody talquetamab-tgvs (Talvey) for this indication.

Findings from the single-arm, phase 2 MajesTEC-1 trial (NCT04557098), which investigated teclistamab in patients with relapsed/refractory multiple myeloma, supported the FDA approval of teclistamab. In this trial, teclistamab elicited an overall response rate of 61.8% (95% CI, 52.1%-70.9%) in patients with multiple myeloma who were relapsed/refractory to 3 or more prior therapies, including a PI, an IMiD, and an anti-CD38 monoclonal antibody (n = 110). Furthermore, at a median follow-up of 7.4 months, the estimated 9-month duration of response rate among responders was 66.5% (95% CI, 38.8%-83.9%).

However, the patient population in MajesTEC-1 did not include those with prior exposure to other BCMA-directed therapies, thus limiting oncologists’ ability to translate the data from MajesTEC-1 to the real-world setting, Grajales-Cruz explains. Variations in patient characteristics often exist between clinical trial populations and real-world populations, particularly in the community setting, Grajales-Cruz emphasizes. These population discrepancies prompted the evaluation of teclistamab in a real-world relapsed/refractory multiple myeloma population in comparison with the MajesTEC-1 population, Grajales-Cruz concluded.