Sanofi has reported positive data from the Phase III IKEMA clinical trial of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone to treat patients with relapsed multiple myeloma.
When compared to carfilzomib and dexamethasone alone, Sarclisa combination met the trial’s primary endpoint with significantly improved progression-free survival at first planned interim analysis.
Results also showed no new safety signals with the combination therapy.
Sanofi research and development global head John Reed said: “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.
“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.”
Sanofi’s drug is a monoclonal antibody designed to attach to a specific epitope on the CD38 receptor found on multiple myeloma cells. It works via various mechanisms of action, including apoptosis and immunomodulatory activity.
In the US, the drug in combination with pomalidomide and dexamethasone is approved to treat relapsed refractory multiple myeloma in adults who have had at least two prior therapies.
The randomised, multi-centre, open label IKEMA trial assessed the drug in a total of 302 relapsed multiple myeloma patients at 69 centres across 16 countries.
Participants received intravenous Sarclisa at a 10mg/kg dose once weekly for four weeks, followed by every other week for 28-day cycles. The drug was given with 20mg/56mg/m² carfilzomib twice weekly and dexamethasone at the standard dose.
In addition to the primary endpoint, the trial assessed secondary endpoints, such as overall response rate, minimal residual disease, complete response rate, overall survival, and safety.
Sarclisa is undergoing additional Phase III trials in combination with current standard to treat multiple myeloma. It is also being studied in other blood cancers and solid tumours.