The Phase 3 IMROZ trial evaluating the investigational use of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care.

Thierry Facon, Professor of Haematology in the Department of Haematology, Lille University Hospital, Lille, France, member of French Academy of Medecine and IMROZ Principal Investigator, said: “The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies. First line therapeutic options are critical for all patients, but especially for those who are transplant-ineligible, given attrition rates in subsequent lines of therapy.”

The safety and tolerability of Sarclisa observed in this trial was consistent with the established safety profile of Sarclisa and VRd.

Dietmar Berger, Global Head of Development, Sanofi, said: "This is the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care, reinforcing our belief in Sarclisa as a best-in-class medicine. These data underscore our commitment to advancing scientific innovation for people living with multiple myeloma, and we look forward to sharing more detail on Sarclisa’s potential to improve outcomes for patients receiving earlier lines of therapy.”

Study results will be submitted for presentation at an upcoming medical meeting and form the basis of a future regulatory submission.