The European Commission has granted marketing authorization for Sanofi's Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This approval expands the therapeutic options for patients in the front-line setting and marks a significant advancement in multiple myeloma (MM) treatment within the European Union.
The approval is based on the positive results from the Phase 3 IMROZ study, a randomized, controlled trial evaluating Sarclisa plus standard-of-care VRd in NDMM patients ineligible for transplant. The study demonstrated a statistically significant improvement in progression-free survival (PFS) compared to VRd alone. Specifically, the Sarclisa-VRd combination reduced the risk of disease progression or death by 40% compared to VRd alone in the specified patient population.
Clinical Significance of Sarclisa Approval
This approval is particularly significant because it addresses an unmet need in the front-line treatment of multiple myeloma, especially for patients who are not candidates for ASCT. According to Sanofi oncology global head Olivier Nataf, "there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients." Sarclisa, as the first anti-CD38 therapy combined with VRd in the EU for this patient group, offers a potentially transformative new combination regimen.
Sarclisa's Expanding Role in Multiple Myeloma Treatment
Sarclisa, an anti-CD38 monoclonal antibody, has been previously approved for relapsed/refractory multiple myeloma (R/R MM) in combination with pomalidomide and dexamethasone, as well as with carfilzomib and dexamethasone. This latest approval marks its first indication in NDMM and the third overall approval in the EU. The U.S. Food and Drug Administration (FDA) approved Sarclisa with VRd for a similar indication in September, further validating its efficacy and safety profile.
Ongoing Development and Future Directions
Sanofi is actively pursuing further development of Sarclisa through a comprehensive clinical program encompassing multiple Phase 2 and Phase 3 studies across various settings within the MM treatment continuum. These studies include investigations into a subcutaneous (SC) formulation of Sarclisa, aimed at improving patient convenience and comfort. Data from a late-stage study indicated that the SC formulation was as effective as the intravenous formulation in R/R MM, highlighting the potential for enhanced patient experience with this alternative administration route.
