ISATUXIMAB (Sarclisa®, Sanofi), an anti-CD38 monoclonal antibody, has received approval by the U.S. Food and Drug Administration (FDA) for use in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who had previously received two or more therapies including lenalidomide and a proteasome inhibitor.
The approval of isatuximab is based on the results from the open-label, randomised Phase III clinical trial ICARIA-MM (N=307). The drug, which works by assisting the immune system attack multiple myeloma cancer cells, was given alongside pomalidomide and dexamethasone and compared to a drug combination of pomalidomide and dexamethasone.
In the isatuximab drug combination group, median progression-free survival at the median follow-up of 11.6 months was 11.5 months compared with 6.5 months in patients with pomalidomide and dexamethasone alone (hazard ratio: 0.60; p=0.001). Overall response rates were 60.4% and 35.3%, respectively.
One death in the isatuximab group occurred (<1%) as the result of a treatment-related adverse event (sepsis) in comparison to two in the pomalidomide and dexamethasone group (1%; pneumonia and urinary tract infection). Common side effects experienced with the use of isatuximab included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhoea, anaemia, lymphonenia, and thrombocytopenia.
“In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy,” commented Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. He further noted that: “While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies.”