Multiple Myeloma

New Drug: Talquetamab-tgvs for relapsed or refractory multiple myeloma

2023-06-07

  • Study

    Multicenter, open-label, single-arm trial
    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
    Talquetamab-tgvs (n=187); Cohort 1: talquetamab 0.4 mg/kg/weekly (n=100); Cohort 2: talquetamab 0.8 mg/kg/weekly (n=87)

  • Efficacy

    Cohort 1: ORR:73% [63.2-81.4], mDoR: 9.5 mos [6.5-NR]
    Cohort 2: ORR:73.6% [63-82.4], mDoR: NR

  • Safety

    Any grade: CRS (>20%), dysgeusia (>20%), nail disorder (>20%), musculoskeletal pain (>20%), upper respiratory infection (>20%)
    • https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf

    Reviewed by Elvin CHALABİYEV, MD on SEP 10, 2023