Melphalanflufenamid (1) – Pepaxti®

• Clinical trials
  • In the randomised, open-label, controlled Phase III OCEAN trial, treatment with melphalan flufenamide in combination with dexamethasone was compared with the combination therapy of pomalidomide and dexamethasone (Pd).
  • The single-arm, open-label Phase II HORIZON trial, which investigated treatment with melphalan flufenamide in combination with dexamethasone, enrolled patients with relapsed, refractory multiple myeloma who had received at least two prior lines of treatment, including an immunomodulatory agent and a proteasome inhibitor.

Adults with multiple myeloma who have previously received at least three lines of treatment, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one monoclonal CD38 antibody, and who have shown disease progression during or after their most recent treatment; time to progression of at least three years in patients who have previously undergone an autologous stem cell transplant

• An additional benefit is not proven.
• There are therefore no suitable data available to demonstrate any additional benefit of melphalan flufenamide in combination with dexamethasone compared with the appropriate comparator therapy.
• Overall assessment
  • As there are therefore no suitable data to provide proof of an additional benefit of melphalan flufenamide in combination with dexamethasone compared with the appropriate comparator therapy, an additional benefit of melphalan flufenamide in combination with dexamethasone is not proven.

Courtesy translation only, please refer to the German original.