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TALVEY - Interference with Immunofixation Assays

Last Updated: 08/13/2024

SUMMARY  

  • Immunofixation electrophoresis (IFE) assays are used for the detection of M-protein to confirm complete response (CR) per International Myeloma Group (IMWG) criteria.1,2
  • The ability of talquetamab to interfere with the IFE assay was assessed by testing talquetamab migration in the assay.1
  • The talquetamab qualitative limit of detection in the IFE assay was 200 - 300 µg/mL in phosphate-buffered solution and non-interfering multiple myeloma (MM) serum.1
  • The steady state of talquetamab at the 0.4 mg/kg once weekly (QW) subcutaneous (SC) and the 0.8 mg/kg once every other week (Q2W) SC recommended phase 2 dose (RP2D) in the pivotal trial was determined to be 3.1 - 3.5 µg/mL.1
  • Since the steady state concentration of talquetamab is lower than the qualitative limit of detection, it is unlikely that talquetamab would be detected and is not expected to interfere with the IFE assay.1

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 09 August 2024.

 

References

1 Data on File. Health Authority Response. Janssen Research and Development, LLC.; 2023.  
2 Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-e346.