FRANCE – Sanofi’s anti-CD38 monoclonal antibody Sarclisa has demonstrated promising results in Phase III clinical trial for the treatment of newly diagnosed,transplant-ineligible multiple myeloma (MM) patients. 

The IMROZ study, which enrolled 446 patients across 21 countries, evaluated Sarclisa in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd) versus VRd alone.

The study met its primary endpoint, with the Sarclisa combination therapy reducing the risk of disease progression or death by 40% compared to VRd alone. 

At 60 months, the estimated progression-free survival (PFS) rate was 63.2% in the Sarclisa/VRd group versus 45.2% in the VRd group. 

The median PFS has not yet been reached in the trial.

“Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease,” said Dietmar Berger, M.D., Ph.D., Chief Medical Officer and Global Head of Development at Sanofi. 

“The filing acceptances, as well as the FDA’s Priority Review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”

The U.S. Food and Drug Administration (FDA) has accepted Sanofi’s supplemental Biologics License Application (sBLA) for priority review of Sarclisa in combination with VRd for the treatment of transplant-ineligible newly diagnosed MM patients. 

The target action date for the FDA decision is September 27, 2024. A regulatory submission is also under review in the European Union.

Key secondary endpoints from the IMROZ study showed that 74.7% of patients in the Sarclisa/VRd group achieved a complete response (CR), compared to 64.1% in the VRd group. 

The minimal residual disease (MRD) negativity rate for patients with a CR, very good partial response (VGPR), or better was 55.5% in the Sarclisa/VRd group versus 40.9% in the VRd group. 

Additionally, 46.8% of patients in the Sarclisa/VRd group sustained MRD negativity for at least 12 months, compared to 24.3% in the VRd group.

The safety profile of the Sarclisa combination therapy was consistent with the established safety profiles of Sarclisa and VRd. 

The IMROZ study is the fourth Phase III study investigating Sarclisa combinations in newly diagnosed MM patients to show superiority versus standard-of-care VRd and KRd (carfilzomib, lenalidomide, and dexamethasone), further reinforcing its potential as a best-in-class treatment option.

Justine Ra, a medical writer covering the ASCO24 conference, stated that the IMROZ study results, show Sarclisa can significantly improve outcomes for newly diagnosed, transplant-ineligible multiple myeloma patients when combined with standard therapy.

Justine Ra further stated that if Sarclisa is approved it would become the first anti-CD38 therapy available for this patient population, providing a much-needed new treatment option.

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