The European Commission has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This decision marks Sarclisa as the first anti-CD38 therapy approved in the EU for use in combination with VRd for this patient population.
The approval is based on the positive results from the IMROZ phase 3 study, a global trial that evaluated Sarclisa in combination with VRd versus VRd alone. The study demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with the Sarclisa combination. The safety and tolerability profile of Sarclisa was consistent with previous findings, with no new safety signals identified.
IMROZ Phase 3 Trial
The IMROZ trial is the first global phase 3 study assessing a CD38 monoclonal antibody combined with the standard-of-care VRd regimen in transplant-ineligible NDMM patients. The trial's results, presented at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) meetings, and published in The New England Journal of Medicine, highlight the clinical benefit of adding Sarclisa to the VRd regimen.
Sarclisa's Mechanism of Action
Sarclisa (isatuximab) is a CD38 monoclonal antibody designed to target a specific epitope on the CD38 receptor found on multiple myeloma cells. It induces antitumor activity through multiple mechanisms, including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly expressed on multiple myeloma cells, making it an effective target for antibody-based therapies.
Current Approvals and Future Development
Sarclisa is currently approved in over 50 countries, including the United States and the EU, for various indications in multiple myeloma. Sanofi is also evaluating a subcutaneous administration method for Sarclisa in clinical studies. Regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and China, potentially expanding its availability globally.
Olivier Nataf, Global Head of Oncology at Sanofi, stated, “While there have been many important advancements in multiple myeloma treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients. With today’s decision the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in multiple myeloma treatment.”
