Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 96

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 96
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-COMET Phase 2 long-term extension study in pediatric patients with infantile-onset Pompe disease (IOPD) suggested that Nexviazyme meaningfully improved ptosis, or drooping eyelid, over nearly three years. Additionally, positive safety debut data were obtained from the Baby-COMET Phase 3 study, the first study in over 20 years of any treatment in naive IOPD patients. This Phase 3 study is currently ongoing and is expected to read out in 2026. Sarclisa is a monoclonal antibody designed to selectively bind to CD38, a cell surface antigen expressed in MM cancer cells and other hematological malignancies. Sarclisa is approved in several countries in combination settings for the treatment of adults with relapsed refractory multiple myeloma (RRMM). Sarclisa is under evaluation in combination with current standard and novel treatments across the MM treatment continuum. Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant was approved by the FDA in September 2024 and in the EU and in China in January 2025. The regulatory submission in this indication for Sarclisa is currently under review in Japan, supported by the IMROZ Phase 3 study. This study demonstrated that Sarclisa in combination with standard-of-care VRd, followed by Sarclisa-Rd, improved progression-free survival (PFS) and led to a rapid and greater depth of response compared to VRd alone, as shown by minimal residual disease (MRD) negativity rate over time, in transplant- ineligible patients with newly diagnosed MM. New results from the German-speaking Myeloma Multicenter Group (GMMG)-HD7 Phase 3 study showed that Sarclisa in combination with lenalidomide, bortezomib and dexamethasone (RVd) during induction therapy in NDMM, transplant-eligible, significantly prolonged PFS from first randomization, resulting in a statistically significant and clinically meaningful reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen. The study results supported the regulatory submission that is currently under review by the EMA. The development of a new subcutaneous formulation of Sarclisa at a fixed dose in combination with pomalidomide and dexamethasone (P