Phase III study: Sarclisa improves progression-free survival of patients with multiple myeloma

Sanofi announces promising results for its monoclonal antibody Sarclisa (isatuximab) in combination with a VRd protocol (bortezomib, lenalidomide and dexamethasone). In the Phase III IMROZ study, this treatment reduced the risk of disease progression or death by 40% in patients with newly diagnosed multiple myeloma who were not eligible for transplantation.

At the data cut-off date, the results show a median progression-free survival not reached for Sarclisa-VRd compared to 54.3 months for VRd alone. Additionally, progression-free survival at 60 months was 63.2% for the Sarclisa-VRd group, compared to 45.2% for the VRd group.

Grade ≥3 adverse events affected 91.6% of patients on Sarclisa-VRd and 84% on VRd. No new security signals have been detected. These results are published in the NEJM and presented at ASCO.