Linvoseltamab (1) – Lynozyfic®

• Clinical trials
  • The LINKER-MM1 trial is an open-label, single-arm Phase I/II trial designed to investigate the efficacy and safety of linvoseltamab.

a) Adults with relapsed or refractory multiple myeloma who have received three prior lines of treatment and have shown disease progression during their most recent treatment; Prior treatment includes a proteasome inhibitor, an immunomodulatory active ingredient (INN) and a monoclonal anti-CD38 antibody

• An additional benefit is not proven.
• Due to its single-arm design, the LINKER-MM1 trial does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of linvoseltamab compared with the appropriate comparator therapy.
• The additional non-randomised comparisons submitted are not suitable for assessing additional benefit.
• There is therefore no evidence of additional benefit from linvoseltamab in the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, is not proven.
• Conclusion
  • The results of the single-arm LINKER-MM1 study are available for the assessment of the additional benefit of linvoseltamab.
  • In addition, the pharmaceutical manufacturer has provided results from non-randomised comparisons, partly adjusted for potential confounders using propensity scores and partly using MAIC analyses.
  • The results of the single-arm study are not suitable for assessing additional benefit, as they do not allow for comparison with the appropriate comparator therapy.
  • MAIC analyses using aggregated study data are generally not considered appropriate in the context of benefit assessment.
  • There are numerous uncertainties regarding the comparison using propensity score adjustment.
  • Consequently, there is no evidence of additional benefit from linvoseltamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, there is no proof.

b) Adults with relapsed or refractory multiple myeloma who have received at least four prior therapies and who have shown disease progression during their most recent treatment; Prior treatment includes a proteasome inhibitor, an immunomodulatory active ingredient (INN) and a monoclonal anti-CD38 antibody

• An additional benefit is not proven.
• Due to its single-arm design, the LINKER-MM1 study does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of linvoseltamab compared with the appropriate comparator therapy.
• The additional non-randomised comparisons submitted are not suitable for assessing additional benefit.
• There is therefore no evidence of additional benefit from linvoseltamab in the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, proof that this is not proven.
• Conclusion
  • The results of the single-arm LINKER-MM1 study are available for the assessment of the additional benefit of linvoseltamab.
  • In addition, the pharmaceutical manufacturer has provided results from non-randomised comparisons, partly adjusted for potential confounders using propensity scores and partly using MAIC analyses.
  • The results of the single-arm study are not suitable for assessing additional benefit, as they do not allow for comparison with the appropriate comparator therapy.
  • MAIC analyses using aggregated study data are generally not considered appropriate in the context of benefit assessment.
  • There are numerous uncertainties regarding the comparison using propensity score adjustment.
  • Consequently, there is no evidence of additional benefit from linvoseltamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, there is no proof.

Courtesy translation only, please refer to the German original.