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Recently, Johnson & Johnson announced that the U.S. FDA has approved its supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab), a bispecific antibody targeting B-cell maturation antigen (BCMA).For reducing the dosing frequency to once every two weeks (1.5 mg/kg) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained complete response (CR) for at least six months.This approval provides greater flexibility in dosing regimens for patients using weight-based treatment plans.

This approval is mainly based on the results of the MajesTEC-1 phase 1/2 clinical trial. In the study, patients initially received subcutaneous injections of Tecvayli at the recommended phase 2 dose (RP2D, 1.5 mg/kg) once a week. When patients achieved a confirmed complete response (CR) for more than six months, they became eligible to reduce the dosing frequency to once every two weeks (1.5 mg/kg) until disease progression or unacceptable toxicity occurred.

Previously announced positive results from the MajesTEC-1 trial showed that, in 165 RRMM patients receiving weekly subcutaneous injections of teclistamab,The overall response rate reached 63%. Notably, 58.8% of patients achieved a very good partial response (VGPR) or better, and 39.4% of patients achieved a complete response (CR) or better.

▲Teclistamab Response Rate Data in the MajesTEC-1 Trial (Source: Reference [2])

The results of this clinical trial were published in The New England Journal of Medicine. The trial showed that patients achieved deep and durable remission.The median duration of response was 18.4 months, the median progression-free survival was 11.3 months, and the median overall survival was 18.3 months.

Multiple Myeloma: The Second Most Common Malignancy in the Hematologic System, Accounting for Approximately 10% of Hematologic Malignancies

BCMA is a popular target for treating B-cell hematologic malignancies. Antibody-drug conjugates and CAR-T therapies targeting BCMA have been approved by the FDA for marketing.Tecvayli is a fully humanized bispecific antibody that simultaneously targets BCMA and the CD3 receptor on the surface of T cells.It isFirst ApprovedThe bispecific therapy for treating multiple myeloma is also the first approved bispecific antibody targeting BCMA, providing an "off-the-shelf" treatment option for refractory patients.

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References:

[1] TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma. Retrieved February 20, 2024 from https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-us-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-302066627.html

[2] Moreau et al., (2022). Teclistamab in Relapsed or Refractory Multiple Myeloma. NEJM, DOI: 10.1056/NEJMoa2203478

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