Isatuximab-irfc Combination Therapy for Multiple Myeloma Approved by FDA
Posted: Tuesday, March 3, 2020
Yesterday, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor. Isatuximab-irfc is a CD38-directed cytolytic antibody that assists specific cells in the immune system in attacking multiple myeloma cancer cells.
The FDA approval is based data from the phase III ICARIA-MM clinical trial of the efficacy of isatuximab-irfc in combination with pomalidomide and dexamethasone. The study enrolled 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Patients received either isatuximab-irfc in combination with pomalidomide and low-dose dexamethasone or pomalidomide and low-dose dexamethasone. The trial met its primary outcome of progression-free survival, with patients receiving the study drug showing a 40% reduction in the risk of disease progression or death compared with patients receiving pomalidomide and dexamethasone. In addition, patients who received the triplet therapy had a better overall response rate compared with patients who received pomalidomide and low-dose dexamethasone (60.4% vs. 35.3%).
Common side effects of the study drug included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia. Serious side effects involved intravenous infusion-related reactions along with grade 3 or higher reactions. Additionally, a higher incidence of second primary malignancies was observed with the addition of isatuximab-irfc in this study.