PARIS (dpa-AFX) - French drug maker Sanofi SA (SNYNF) announced Tuesday that Sarclisa (isatuximab) Phase 3 IKEMA trial met the primary endpoint in patients with relapsed multiple myeloma. The study results were released early based on recommendation of an Independent Data Monitoring Committee.
The company said the trial evaluated Sarclisa added to carfilzomib and dexamethasone. The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries.
The trial demonstrated 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.
The company will submit the results to an upcoming medical meeting. The results are anticipated to form the basis of regulatory submissions planned for later this year.
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells.
The company noted that the use of Sarclisa in combination with carfilzomib and dexamethasone in relapsed multiple myeloma is investigational and has not been fully evaluated by any regulatory authority.
John Reed, Global Head of Research and Development at Sanofi, said, '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.'
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