weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA was PFS. Secondary endpoints included ORR, the rate of CR or better, the rate of VGPR or better, rate ofMRD-negativity, OS and safety.1
The results from IKEMA are anticipated to form the basis of regulatory submissions planned for later this year. The use of Sarclisa in combination with carfilzomib and dexamethasone in relapsed MM is investigational and has not been evaluated by any regulatory authority.
About Sarclisa
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
Sarclisa is approved in the EU, U.S., Switzerland, Canada and Australia in combination withpom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.
For more information on Sarclisa clinical trials please visitwww.clinicaltrials.gov.
About Multiple Myeloma (MM)
MM is the second most common hematologic malignancy, with more than 138,000 new diagnoses of MM worldwide yearly.2,3 Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.
About Sanofi
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