On February 5, Sanofi announced that the pivotal phase III ICARIA-MM study of isatuximab in relapsed and refractory multiple myeloma reached the primary endpoint and that isatuximab in combination with standard therapy (pomalidomide + low-dose dexamethasone) significantly prolonged progression-free survival (PFS) compared to standard therapy alone.
The open-label study, the first randomized phase III study to assess the clinical benefit of adding a monoclonal antibody to standard therapy in patients with relapsed or refractory multiple myeloma, enrolled 307 patients at 96 centers in 24 countries.All enrolled patients had previously received more than 2 treatment regimens including lenalidomide and a proteasome inhibitor alone or in combination, intravenous isatuximab 10 mg/kg once weekly for 4 weeks, followed by a 28-day cycle of pomalidomide plus dexamethasone.The detailed results of the study will be presented at a conference shortly and will serve as key data for the isatuximab marketing application.
Multiple myeloma is the second most common type of hematologic malignancy, with approximately 13 per year worldwide.80,000 newly diagnosed cases.For most patients, multiple myeloma remains incurable and represents a significant burden of disease.
isatuximab is a CD38 monoclonal antibody that has been granted orphan drug status by the FDA and EMA for the treatment of relapsed and refractory multiple myeloma.The ICARIA-MM study is one of four phase III studies of isatuximab in patients with relapsed or refractory or newly diagnosed multiple myeloma conducted by Sanofi.In addition to MM, Sanofi is conducting clinical studies of isatuximab in other hematologic malignancies and solid tumors.
Currently, there is only one CD38 monoclonal antibody drug marketed by Johnson & Johnson in the world. From the earliest fourth-line therapy for multiple myeloma to the current first-line therapy, the annual sales of Daratumumab have reached 20 years after its launch.$2.5 billion.Isatuximab is the only CD38 monoclonal antibody currently in phase III development.