Sarclisa First Anti-CD38 to Boost PFS with VRd in New Multiple Myeloma Patients

Recent data from the IMROZ phase 3 clinical trial have demonstrated promising outcomes for Sarclisa (isatuximab) in combination with standard-of-care drugs VRd (bortezomib, lenalidomide, and dexamethasone) for newly diagnosed, transplant-ineligible multiple myeloma (NDMM) patients.

Key Findings:
The IMROZ study revealed that the Sarclisa-VRd regimen significantly reduced the risk of disease progression or death by 40% compared to VRd alone. This ground-breaking result was achieved after a median follow-up of 59.7 months and marks the first time an anti-CD38 monoclonal antibody has shown such efficacy in combination with VRd for this patient demographic.

Study Design and Results:
The IMROZ study is a global, randomized, multi-center, open-label trial that enrolled 446 NDMM patients across 21 countries. Sarclisa was administered in combination with VRd initially, followed by Sarclisa with lenalidomide and dexamethasone. The primary endpoint, progression-free survival (PFS), demonstrated a median PFS duration that was not reached for the Sarclisa-VRd group compared to 54.3 months for the VRd group. The estimated PFS at 60 months was significantly higher in the Sarclisa-VRd group (63.2%) compared to the VRd group (45.2%).

Secondary Endpoints:
In terms of secondary endpoints, approximately 74.7% of patients treated with Sarclisa-VRd achieved a complete response (CR), compared to 64.1% with VRd alone. Additionally, 55.5% of patients in the Sarclisa-VRd group achieved minimal residual disease (MRD) negative CR, as opposed to 40.9% in the VRd group. Sustained MRD negativity for at least 12 months was also higher in the Sarclisa-VRd group (46.8%) compared to the VRd group (24.3%).

Safety Profile:
The safety profile of Sarclisa in the study was consistent with previous findings, with no new safety concerns arising. Grade 3 or higher treatment-emergent adverse events (TEAEs) were observed in 91.6% of patients in the Sarclisa-VRd group versus 84% in the VRd group. Treatment discontinuation due to adverse events occurred in 22.8% and 26% of patients in the Sarclisa-VRd and VRd groups, respectively.

Expert Opinions:
Thierry Facon, MD, Principal Investigator of the IMROZ study, highlighted the importance of these findings for NDMM patients who are not eligible for transplant, emphasizing that effective frontline therapy could significantly alter the course of the disease. Peter C. Adamson, Global Development Head of Oncology, expressed optimism about Sarclisa's potential to improve outcomes for multiple myeloma patients.

Regulatory Status:
The investigational use of Sarclisa-VRd has led to regulatory submissions in the United States and the European Union, with the U.S. FDA accepting a supplemental Biologics License Application (sBLA) for priority review. If approved, Sarclisa would be the first anti-CD38 therapy combined with VRd for newly diagnosed, transplant-ineligible multiple myeloma patients.

Future Presentations and Research:
The IMROZ data will be presented at the European Hematology Association (EHA) Annual Congress and is featured in the 2024 Best of ASCO program. Sanofi continues to explore Sarclisa's potential in additional phase 3 clinical trials across the multiple myeloma treatment continuum and for other hematologic malignancies.

Conclusion:
The IMROZ phase 3 study highlights the potential of Sarclisa-VRd as a transformative therapy for newly diagnosed, transplant-ineligible multiple myeloma patients, offering hope for improved survival and better disease management.

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