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Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody.

ABSTRACT: Teclistamab is a BCMAxCD3 bispecific antibody, the first approved for the treatment of relapsed or refractory multiple myeloma. Given its impressive efficacy in heavily pretreated patients and better accessibility compared to BCMA-directed CAR T cells, teclistamab is sure to become a staple of relapsed/refractory multiple myeloma therapy. Teclistamab carries a set of notable adverse effects including cytokine release syndrome (CRS), infections, and neurotoxicity for which providers must take unique precautions and prophylactic measures. Here, we review the preclinical and clinical data, which led to teclistamab's approval, important patient selection considerations, strategies for managing CRS and other side effects, and finally the future of bispecific antibody therapy in multiple myeloma.

SUBMITTER: Pan D

PROVIDER: S-EPMC10368105 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody.

Pan Darren D Richter Joshua J

Cancer management and research 20230721

Teclistamab is a BCMAxCD3 bispecific antibody, the first approved for the treatment of relapsed or refractory multiple myeloma. Given its impressive efficacy in heavily pretreated patients and better accessibility compared to BCMA-directed CAR T cells, teclistamab is sure to become a staple of relapsed/refractory multiple myeloma therapy. Teclistamab carries a set of notable adverse effects including cytokine release syndrome (CRS), infections, and neurotoxicity for which providers must take uni ...[more]

PMID: 37497430

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Project description:BackgroundTeclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma.MethodsIn this phase 1-2 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Patients received a weekly subcutaneous injection of teclistamab (at a dose of 1.5 mg per kilogram of body weight) after receiving step-up doses of 0.06 mg and 0.3 mg per kilogram. The primary end point was the overall response (partial response or better).ResultsAmong 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines). With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. A total of 44 patients (26.7%) were found to have no minimal residual disease (MRD); the MRD-negativity rate among the patients with a complete response or better was 46%. The median duration of response was 18.4 months (95% confidence interval [CI], 14.9 to not estimable). The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Common adverse events included cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4), neutropenia (in 70.9%; grade 3 or 4, 64.2%), anemia (in 52.1%; grade 3 or 4, 37.0%), and thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%). Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2).ConclusionsTeclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).

Dataset Information

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody.

Publications

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody.

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