Dr Dima on the Implications of a Real-World Analysis of Teclistamab in Multiple Myeloma

Danai Dima, MD, hematology-oncology fellow, Cleveland Clinic, discusses the implications of real-world data derived from the phase 2 MajesTEC-1 trial (NCT04557098), an investigation of treatment with teclistamab-cqyv (Tecvayli) in pretreated patients with relapsed/refractory multiple myeloma, findings from which were presented at the 2023 ASH Annual Meeting.

Administration of the T-cell redirecting bispecific antibody teclistamab showed effectiveness and a well-tolerated safety profile in this real-world cohort of patients, mirroring the outcomes observed in patients enrolled onto the MajesTEC-1 trial, Dima begins. This real-world analysis, which incorporated multivariate analyses, revealed that patients who had undergone more than 4 lines of therapy exhibited lower response rates, she says. This underscores the importance of early utilization of teclistamab for optimal effectiveness. Many oncologists, whether in academic centers or community practices, may hesitate to employ novel agents in patients with significant illnesses, baseline comorbidities, and organ dysfunction, Dima explains. However, these findings provide evidence that teclistamab is well tolerated and effective even in very ill patients, offering encouraging insights that can prove valuable for oncologists, she emphasizes.

Adverse events (AEs) associated with BCMA-directed bispecific antibodies primarily include cytokine release syndrome (CRS) and neurotoxicity, Dima continues. The real-world rates of these AEs observed in the analysis align with those in the MajesTEC-1 trial, but notably, the occurrence of severe CRS and neurotoxicity, defined as that of grade 3 or higher, in this patient population was relatively low, she elucidates. This raises the possibility of administering teclistamab via step-up dosing in an outpatient setting without hospitalization, provided appropriate infrastructure and resources are in place, Dima states.

Moreover, these findings indicate that community oncologists can potentially manage treatment with teclistamab after the initial step-up dosing, Dima expands. However, it's crucial to acknowledge the high infection and cytopenia risk in these patients, emphasizing the need for vigilant monitoring and close follow up by community oncologists, she says. Ensuring patients receive necessary supportive care, including intravenous immune globulin, growth factors, antimicrobials, and vaccinations, is essential to mitigate the risk of non-relapse mortality, Dima emphasizes.

Although this real-world study had a short follow up, necessitating longer observation for response deepening and durability, the data provide reassurance, especially for community oncologists, that teclistamab is associated with a favorable safety profile, particularly in severely ill patients, Dima notes. The low rates of severe CRS and neurotoxicity, coupled with proper supportive care, can contribute to avoiding AEs such as infections and preventing non-relapse mortality, she concludes.