Dr Garfall on Updated Safety Data for Teclistamab in R/R 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 safety data reported 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.

In updated safety findings from the study presented at the 2024 ASCO Annual Meeting, no new safety signals were reported, which Garfall notes as an important finding for a new class of medication given continuously over the course of months. When evaluating a novel agent such as teclistamab, looking for unusual toxicities that emerge with increased follow-up is important, he says.

Garfall notes that infections remained the primary notable adverse effect (AE) reported during the study. Any-grade infections occurred in 78.8% of patients, and 55.2% of patients had grade 3 or 4 infections. Twenty-two patients experienced grade 5 infections during the study; however, 18 of those patients had grade 5 COVID-19, and with additional follow-up, no new grade 5 COVID-19 events were reported.

Over time, the rate of grade 3 infections generally declined, and Garfall explains that patients transitioning to dosing once every 2 weeks could have helped alleviate the risk of infection.

Additional safety data showed that with further follow-up, no changes in the rates of cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome were reported. Treatment-emergent AEs (TEAEs) led to dose reduction in 1 patient (0.6%), and 8 patients (0.4%) discontinued treatment due to TEAEs, including 5 patients who discontinued treatment due to infections.