Elranatamab (1) – Elrexfio®

• Clinical trials
  • The MagnetisMM-3 trial is an open-label, single-arm PhaseII trial designed to investigate the safety and efficacy of elranatamab for the treatment of adults with relapsed or refractory multiple myeloma whose previous lines of treatment included an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody.

a) Adults with relapsed and refractory multiple myeloma who have received three prior lines of treatment, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last line of treatment

• An additional benefit is not proven.
• Overall, due to its single-arm design, the MagnetisMM-3 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of elranatamab compared with the appropriate comparator therapy.
• Overall assessment
  • The results of the single-arm MagnetisMM-3 study are available for the assessment of the additional benefit of elranatamab. These are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy. Consequently, there is no evidence of any additional benefit of elranatamab 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, proof of this has not been established.

b) Adults with relapsed and refractory multiple myeloma who have received at least four prior treatments, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent course of treatment

• The additional benefit is not proven.
• Overall, due to its single-arm design, the MagnetisMM-3 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of elranatamab compared with the appropriate comparator therapy.
• Overall assessment
  • The results of the single-arm MagnetisMM-3 study are available for the assessment of the additional benefit of elranatamab. These are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy. Consequently, there is no evidence of any additional benefit of elranatamab 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, proof of this has not been provided.

Courtesy translation only, please refer to the German original.