Sanofi’s monoclonal antibody Sarclisa (isatuximab) has hit targets in a late-stage trial, reducing the risk of disease progression or death in patients with relapsed multiple myeloma.
The randomised, multicentre, open label Phase III IKEMA clinical trial involved 302 patients with relapsed multiple myeloma across 69 centres 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.
According to the French drugmaker, the trial met the primary endpoint at its first planned interim analysis, showing “significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma”.
“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, global head of R&D 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 expected to form the basis of regulatory submissions planned for later this year, the firm noted.
