On October 25, 2022, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager teclistamab-cqyv was granted accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.¹

Because of the risk of cytokine-release syndrome and neurologic toxicity, teclistamab is available only through a restricted program called the TECVAYLI Risk Evaluation and Mitigation Strategy (REMS).

Supporting Efficacy Data

Approval was supported by findings in the multicohort, multicenter MajesTEC-1 trial (ClinicalTrials.gov identifier NCT03145181, NCT04557098). A total of 110 patients in the efficacy population with no prior BCMA-targeted therapy received step-up doses of 0.06 and 0.3 mg/kg, followed by 1.5 mg/kg subcutaneously (SC) once weekly until disease progression or unacceptable toxicity.

A partial response or better on independent review committee assessment was achieved in 68 patients (61.8%, 95% confidence interval [CI] = 52.1%–70.9%), with a complete response or better in 31 (28.2%). With a median follow-up of 7.4 months among responders, the median response duration was not estimable, with 90.6% and 66.5% of responses ongoing at 6 and 9 months, respectively.

How It Is Used

The recommended teclistamab dose is 0.06 mg/kg via SC injection on day 1, 0.3 mg/kg on day 4, and 1.5 mg/kg on day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. No dose reduction is recommended.

Safety Profile

Among 165 patients who received teclistamab in MajesTEC-1, the most common adverse events of any grade were pyrexia, cytokine-release syndrome, musculoskeletal pain, injection-site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. Neurologic toxicity of any grade occurred in 57% and immune effector cell–associated neurotoxicity (ICANS), in 6%. The most common grade 3 or 4 laboratory abnormalities were decreased lymphocytes, neutrophils, and white blood cell counts. Serious adverse events occurred in 54% of patients.

Teclistamab has a boxed warning for life-threatening or fatal cytokine-release syndrome and neurologic toxicity, including ICANS. Teclistamab also has warnings/precautions for hepatotoxicity, infections, neutropenia, hypersensitivity and other administration reactions, and embryofetal toxicity. Patients should be advised not to breastfeed while receiving teclistamab. 

REFERENCE

1. Tecvayli (teclistamab-cqyv) injection, for subcutaneous use, prescribing information, Janssen Pharmaceutical Companies, October 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf. Accessed November 16, 2022.