Dr Garfall on Long-Term Data for Teclistamab in Relapsed/Refractory Myeloma

Alfred L. Garfall, MD, MS, director, Autologous Hematopoietic Stem Cell Transplantation, section chief, Myeloma, Hematology-Oncology, Penn Medicine, associate professor of medicine (hematology-oncology), the Hospital of the University of Pennsylvania, discusses updated findings from the phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098) assessing teclistamab-cqyv (Tecvayli) in patients with relapsed/refractory multiple myeloma.

In October 2022, the FDA granted accelerated approval to teclistamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The regulatory decision was based on prior data from MajesTEC-1.

Updated findings presented at the 2024 ASCO Annual Meeting showed that at a median follow-up of 30.4 months, 38 patients remained on the treatment, including 37 who switched to a less frequent dosing schedule of once every 2 weeks vs once every week. Notably, in February 2024, findings from MajesTEC-1 also supported the FDA approval of teclistamab at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response (CR) or greater for at least 6 months.

Long-term data showed that the overall response rate (ORR) was 63.0% among all patients treated at the recommended phase 2 dose (n = 165), including a CR or better rate of 46.1%. Additionally, 87.7% of evaluable patients (n = 48 of 56) achieved minimal residual disease (MRD) negativity at a 10-5 sensitivity at any point. for a minimum of 6 months. MRD negativity was sustained for a minimum of 6 months in 56.1% of evaluable patients (n = 23 of 41) and a minimum of 12 months in 38.9% of patients (n = 14 of 36).

In all patients, the median progression-free survival (PFS) was 11.4 months (95% CI, 8.8-16.4). In those who experienced a CR or better (n = 76), the median PFS was not reached (95% CI, 26.9–not evaluable [NE]). Patients who had a very good partial response or better (n = 98) achieved a median PFS of 26.7 months (95% CI, 19.4-NE).