Saturday, June 22, 2024

FDA Priority Review for Sarclisa in Multiple Myeloma Treatment

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The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). If approved, Sarclisa would be the first anti-CD38 therapy combined with standard-of-care VRd in newly diagnosed patients not eligible for transplant. The FDA decision is expected by September 27, 2024.

Dietmar Berger, M.D., Ph.D., Chief Medical Officer and Global Head of Development at Sanofi, stated, “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. The FDA’s Priority Review designation reinforces our confidence in Sarclisa as a potential best-in-class treatment and represents a critical step toward advancing this combination in difficult-to-treat cancer.”

The sBLA and the EU submission are based on positive results from the IMROZ phase 3 clinical study evaluating Sarclisa in combination with VRd. In December 2023, the study met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS) with Sarclisa plus VRd compared to VRd alone in transplant-ineligible NDMM patients. The safety and tolerability of Sarclisa observed in this study were consistent with its established safety profile.

IMROZ Phase 3 Study Highlights Sarclisa’s Potential in Treating Newly Diagnosed Multiple Myeloma

The IMROZ study is the fourth phase 3 study investigating Sarclisa combinations in NDMM patients, reinforcing its best-in-class potential. The results will be featured during an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and during the plenary scientific session at the 2024 European Hematology Association (EHA) Annual Congress.

The global, randomized, multi-center, open-label IMROZ phase 3 clinical study enrolled 446 patients with newly diagnosed, transplant-ineligible multiple myeloma across 21 countries and 104 centers. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during the first 42-day cycle and once every two weeks in cycles 2 to 4, combined with subcutaneous bortezomib, oral lenalidomide, and intravenous or oral dexamethasone. Subsequently, Sarclisa was administered every two weeks from cycle 5 to 17 and every four weeks in cycles 18+ during 28-day cycles, combined with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable safety profile, or patient decision to stop treatment.

The primary endpoint was progression-free survival. Key secondary endpoints included complete response rate, minimal residual disease (MRD) negativity rate for patients with a complete response, very good partial response or better rate, and overall survival. Other secondary endpoints were overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival on the next line of therapy, progression-free survival by MRD status, sustained MRD negativity for 12 months, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status.

Multiple Myeloma

Advancing Multiple Myeloma Treatment with Monoclonal Antibody Therapy

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells, inducing antitumor activity through multiple mechanisms, including programmed tumor cell death and immunomodulatory activities. CD38 is highly expressed on the surface of multiple myeloma cells, making it a potential target for antibody-based therapeutics like Sarclisa.

Based on the phase 3 ICARIA-MM study, Sarclisa is approved in over 50 countries, including the U.S. and EU, combined with pomalidomide and dexamethasone for treating certain patients with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on their last therapy. Based on the phase 3 IKEMA study, Sarclisa is also approved in combination with carfilzomib and dexamethasone in 50 countries, including the U.S., for treating patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with multiple myeloma who have received at least one prior therapy.

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Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical studies in combination with current standard treatments across the multiple myeloma treatment continuum. It is also under investigation for treating other hematologic malignancies, with its safety and efficacy not yet evaluated by any regulatory authority outside its approved indication.


Resource: Sanofi, May 27, 2024

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