Teclistamab (1) – Tecvayli®

• Clinical trials
  • The MajesTEC-1 trial is an open-label, single-arm Phase I/IIstudy investigating the safety and efficacy of teclistamab for the treatment of adults with relapsed or refractory multiple myeloma whose previous lines of therapy included an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody.

Adults with relapsed and refractory multiple myeloma who have received at least three prior lines of treatment, including an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment

• There is therefore no evidence of additional benefit from teclistamab as monotherapy in adults with relapsed and refractory multiple myeloma who have received at least three prior lines of treatment, including an immunomodulator, a proteasome inhibitor and an anti-CD38antibody, and who have shown disease progression during their most recent treatment, is not proven.
• The data submitted are not suitable for a comparison with the appropriate comparator therapy.
• Overall assessment
  • The results of the single-arm MajesTEC-1 study are available for the assessment of the additional benefit of teclistamab.
  • The results of the submitted single-arm MajesTEC-1 trial 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 additional benefit from teclistamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulator, a proteasome inhibitor and an anti-CD38antibody, and who have shown disease progression during their most recent treatment, there is no proof.

Courtesy translation only, please refer to the German original.