SUMMARY

• TECVAYLI is not approved by the regulatory agencies for the treatment of patients with plasma cell leukemia (PCL). Janssen does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• MajesTEC-1 (MMY1001) is a phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).^1,2
  • Per protocol, patients with plasma cell leukemia (>2.0 x 10⁹/L plasma cells by standard differential), were excluded from enrollment.²
• A search of the scientific literature retrieved the following limited information on use in patients with PCL:
  • Bardenbacher et al (2024)³ reported a case of a 59-year-old female patient with PCL who was refractory to several lines of therapy before achieving a complete remission to TECVAYLI, daratumumab and lenalidomide and consolidating allogeneic hematopoietic stem cell (allo-HSCT) transplantation. Prior to allo-HSCT transplantation, TECVAYLI was administered for 10 weeks and 8 weeks in combination with daratumumab and lenalidomide due to a slow clinical response. A 4-month complete remission was reported.
  • Mohan et al (2024)⁴ published a retrospective, real-world study of 110 patients with RRMM treated with TECVAYLI at 5 US academic centers. Two patients included in this study had secondary PCL. Both patients experienced fulminant disease relapse after the first full dose of TECVAYLI.
  • Grajales-Cruz et al (2023)⁵ presented a single-center, retrospective chart review of 22 patients with prior B-cell maturation antigen (BCMA) targeted therapy treated with TECVAYLI; 5% of patients had PCL for which efficacy and safety outcomes were not disclosed.

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 16 January 2025.