What have Evomela clinical trials shown?
The safety and efficacy of Evomela™ (melphalan, Spectrum Pharmaceuticals) was demonstrated in a Phase II study in patients undergoing autologous stem cell transplantation (ASCT). Use of Evomela high-dose chemotherapy led to successful destruction of diseased bone marrow (myeloablation) and subsequent engraftment of transplanted stem cells and production of new blood cells.
The overall response rate (partial response or better) improved from 79% prior to ASCT to 95% at 90 to 100 days post-transplant. In addition, the percentage of patients with a stringent complete response increased from 0% before transplant to 16% at 90 to 100 days post-transplant.
The safety profile was similar to that seen with conventional intravenous melphalan.