Sarclisa Achieves Milestone in Phase III IMROZ Trial for Myeloma Treatment

Sarclisa® (isatuximab-irfc), when added to the combination of Velcade (bortezomib), Revlimid  (lenalidomide), and dexamethasone (VRd), has been found to significantly reduce disease progression or the risk of death as compared to using VRd alone. This marks the first global phase III study to reveal positive outcomes when using an anti-CD38 therapy like Sarclisa in conjunction with VRd, specifically in patients who are not eligible for transplantation. 

The results of the study will be presented at an upcoming medical meeting and will serve as the foundation for a future submission for regulatory approval. On December 7, 2023, in Paris, the phase III IMROZ trial, which investigated Sarclisa in combination with the standard bortezomib, lenalidomide, and dexamethasone (VRd), achieved its main goal during a planned interim analysis. The trial demonstrated a significant improvement in progression-free survival (PFS) when compared to using VRd alone. It's important to note that this is the second Phase 3 trial focusing on Sarclisa in newly diagnosed patients, and in both cases, it has shown to be better than the standard of care. Read the full press release to learn more.