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d the risk of progression or death by nearly half formed the basis for this important EC approval. Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM.

France generalUnited statesUnited kingdomSouth koreaEva schaefer jansenSuzanne grecoArnaud delepineFelix lauscherPhilippe moreauInnovationat sanofiFara berkowitzPeterc adamsonSally bainUniversity hospital of nantesInternational myeloma foundationEuropean commission