The Phase III IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. There were no new safety signals identified in this study.
“When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase III trial, results clearly demonstrated a significant reduction in risk of disease progression or death,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. “This is the second positive phase III trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.” Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.
About the Trial : The randomized, multi-center, open label Phase III IKEMA clinical trial enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. All study participants received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA is progression-free survival. Secondary endpoints include overall response rate, the rate of very good partial response or greater, minimal residual disease, complete response rate, overall survival and safety.