OrganicChilli
Senior Member (Voting Rights)
Teclistamab (Tecvayli®) is a first-in-class T-cell redirecting bispecific antibody that targets CD3 on the surface of T-cells and B-cell maturation antigen (BCMA) on plasma cells [1]. Teclistamab was approved by the FDA for patients with relapsed/refractory multiple myeloma (RRMM) after 4 lines of therapy including an immunomodulatory drug (IMID), proteasome inhibitor (PI), and anti-CD38 monoclonal antibody (mAb) based on the results of the phase 1/2 MajesTEC-1 study. Among the 165 patients treated with teclistamab, the overall response rate (ORR) was 63% with 58.8% of patients achieving a very good partial response (VGPR) or better. The median duration of response (DOR) was 18.4 months, median progression free survival (PFS) was 11.3 months, and median overall survival (OS) was 18.3 months [2].
The approved schedule per the package insert for teclistamab is 2 step-up doses at least 48 hours apart followed by the first full dose administration (0.06, 0.3, and 1.5 mg/kg). The most common adverse events were neutropenia (70.9%; grade 3–4: 64.2%) and cytokine release syndrome (CRS; 72.1%; grade 3–4: 0.6%). The median time to onset of CRS was two days (range 1–6) and median duration was 2 days (range, 1–9) [2]. CRS and immune effector cell neurotoxicity syndrome (ICANS) are adverse events of special interest among patients receiving T-cell redirecting therapies. A risk evaluation and mitigation strategy (REMS) program was implemented to effectively deliver teclistamab without compromising on safety. The FDA approval label recommends hospitalization for 48 h after each step-up dose and the first full dose [1]. Our objective was to reduce the incidence of higher-grade CRS with prophylactic administration of tocilizumab to mitigate the risk of CRS and facilitate outpatient administration of teclistamab.
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The approved schedule per the package insert for teclistamab is 2 step-up doses at least 48 hours apart followed by the first full dose administration (0.06, 0.3, and 1.5 mg/kg). The most common adverse events were neutropenia (70.9%; grade 3–4: 64.2%) and cytokine release syndrome (CRS; 72.1%; grade 3–4: 0.6%). The median time to onset of CRS was two days (range 1–6) and median duration was 2 days (range, 1–9) [2]. CRS and immune effector cell neurotoxicity syndrome (ICANS) are adverse events of special interest among patients receiving T-cell redirecting therapies. A risk evaluation and mitigation strategy (REMS) program was implemented to effectively deliver teclistamab without compromising on safety. The FDA approval label recommends hospitalization for 48 h after each step-up dose and the first full dose [1]. Our objective was to reduce the incidence of higher-grade CRS with prophylactic administration of tocilizumab to mitigate the risk of CRS and facilitate outpatient administration of teclistamab.
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