Drugmaker Sanofi said topline results from a trial of its monoclonal antibody isatuximab (Sarclisa) plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma found a reduced risk of disease progression or death compared to treatment with carfilzomib and dexamethasone alone.
The company said it was releasing results from the IKEMA trial “based on recommendation of an Independent Data Monitoring Committee.”
“When [isatuximab] 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, MD, PhD, Global Head of Research and Development at Sanofi. “This is the second positive phase III trial for [isatuximab], further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.”
The trial, which was a randomized, open-label phase III study, enrolled 302 patients. “All study participants received one to three prior anti-myeloma therapies. During the trial, [isatuximab] 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 company said.
The primary endpoint of the trial was progression-free survival, and secondary endpoints included overall response, “the rate of very good partial response or greater, minimal residual disease, complete response rate, overall survival, and safety.”
The drug, in combination with pomalidomide and dexamethasone, is FDA approved for treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. The use of isatuximab “in combination with carfilzomib and dexamethasone in relapsed multiple myeloma is investigational and has not been fully evaluated by any regulatory authority.”
These trial results will be presented at an upcoming medical conference, and the company noted that the findings “are anticipated to form the basis of regulatory submissions planned for later this year.”
Peggy Peck, Editor-in-Chief, BreakingMED™
Cat ID: 118
Topic ID: 78,118,730,118,468,935,192,925