Isatuximab (4) – Sarclisa®

• Clinical trials
  • The pharmaceutical manufacturer has submitted, for the benefit assessment, results from the ongoing, open-label, randomised, controlled trial GMMG-HD7, which compares isatuximab + bortezomib + lenalidomide + dexamethasone with bortezomib + lenalidomide + dexamethasone.

Adults with newly diagnosed multiple myeloma who are suitable for autologous stem cell transplantation; induction treatment

• The additional benefit is not proven.
• Overall, the induction therapy with VRd administered in the control arm of the GMMG-HD7 study does not correspond to the appropriate comparator therapy as defined by the G-BA. Consequently, the appropriate comparator therapy was not implemented in the GMMG-HD7 study, and the study is therefore not suitable for assessing additional benefit.
• Overall assessment
  • In summary, the GMMG-HD7 study is not suitable for assessing the additional benefit of isatuximab + bortezomib + lenalidomide + dexamethasone compared with the appropriate comparator therapy. Consequently, there are no suitable data available to enable an assessment of the additional benefit, and consequently, the additional benefit of isatuximab in combination with bortezomib, lenalidomide and dexamethasone in the treatment of patients with newly diagnosed multiple myeloma who are suitable for autologous stem cell transplantation is not proven.

Courtesy translation only, please refer to the German original.