In the late-stage trial called IKEMA, Sarclisa, when added to carfilzomib and dexamethasone, met the primary endpoint by delivering significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone.
The primary endpoint was met at the trial’s first planned interim analysis itself, said the French pharma company.
Sanofi said that there were no new safety signals identified in the IKEMA clinical trial.
The IKEMA trial is a randomised, multi-center, open label study that enrolled 302 patients having relapsed multiple myeloma. All study participants, who were spread across 69 centers in 16 countries had one to three prior anti-myeloma therapies.
During the phase 3 trial, Sarclisa was intravenously infused at a dose of 10mg/kg once weekly for four weeks, followed by every other week for 28-day cycles in combination with carfilzomib weekly twice at the 20/56mg/m2 dose and standard dose of dexamethasone for the duration of treatment.
Secondary endpoints of the IKEMA clinical trial are overall response rate, the rate of very good partial response or greater, complete response rate, minimal residual disease, overall survival, and safety.
Sanofi research and development global head John Reed said: “When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in risk of disease progression or death.
“This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.”
The French pharma company plans to submit the results from the IKEMA trial to an upcoming medical meeting. The findings of the phase 3 trial are expected to form the basis of regulatory submissions planned to be made later this year, said Sanofi.
Sarclisa is a monoclonal antibody that works by binding to a particular epitope on the CD38 receptor on multiple myeloma cells. It has been designed to have multiple mechanisms of action such as programmed tumour cell death and immunomodulatory activity.
The monoclonal antibody in combination with pomalidomide and dexamethasone has approval in the US for the treatment of relapsed refractory multiple myeloma in adults who had at least two prior therapies including lenalidomide and a proteasome inhibitor.