Sanofi (SNY) announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab).With this nod, Sarclisa is now approved, in combination with Velcade (bortezomib) and Bristol Myers’ (BMY) Revlimid (lenalidomide) and dexamethasone (“VRd”), for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant.This approval was expected as the EMA’s Committee for Medicinal Pro ...

Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma Approval is based on positive results from the IMROZ phase 3 study, demonstrating Sarclisa in combination with standard-of-care treatment significantly improved PFS, compared to the standard of care alone in TI NDMMRepresents third indication in the EU, including two for the treatment of adult patients with R/R MM, and one in NDMM Paris, January ...

Key Points Company and Industry Information 1. **Company**: Sanofi (SYN) 2. **Event**: 43rd Annual J.P. Morgan Healthcare Conference 3. **Date**: January 14, 2025 4. **Time**: 12:45 PM ET 5. **Participants**: - Paul Hudson - Chief Executive Officer - Francois-Xavier Roger - Chief Financial Officer - Houman Ashrafian - Executive Vice President and Head of Research and Development - Richard Vosser - JPMorgan - Operator [1] Core Views and Arguments 1. **Progress and Achievements**: CEO Paul Hudson highlights the company's progress over the last five years, expressing pride in the advancements made. 2. **Guidance and Science**: Hudson mentions the company's recent change in guidance and renewed commitment to science, noting that while some raised eyebrows initially, the decision has been validated over the past year. [4] Other Important Content 1. **Dialogue Format**: The session will include a dialogue between the three executives followed by a Q&A session. 2. **Team Involvement**: Hudson acknowledges the involvement of the team, particularly Houman Ashrafian, in the company's journey. [2][3]

Sarclisa SC Formulation Study Results - The phase III IRAKLIA study demonstrated non-inferiority in objective response rate (ORR) and observed concentration before dosing (C trough) for the new SC formulation of Sarclisa compared to the IV formulation when combined with Pomalyst and dexamethasone [1] - The study met key secondary endpoints including very good partial response, incidence rate of infusion reactions, and C trough at cycle two [2] - This is the first phase III study to evaluate SC administration of a cancer drug via an on-body delivery system (OBDS), which aims to improve patient experience [8] Regulatory Status and Approvals - The European Medicines Agency's CHMP recommended approval of Sarclisa in combination with VRd for newly diagnosed multiple myeloma patients ineligible for ASCT, with a final decision expected shortly [4][11] - Sarclisa is already approved in combination with Pomalyst and dexamethasone for relapsed/refractory multiple myeloma patients who have received at least two prior therapies [10] - Regulatory filings for the SC formulation are expected in the US and Europe during the first half of 2025 [9] Company Performance and Industry Context - Sanofi's shares declined 6.2% over the past year, underperforming the industry's 2.2% decrease [8] - The company currently holds a Zacks Rank 3 (Hold) [5] - Puma Biotechnology and CytomX Therapeutics, both with Zacks Rank 1, showed significant earnings estimate revisions and stock price movements [5][12] Additional Clinical Applications - Sarclisa SC formulation is being evaluated in various studies across different combinations and lines of therapy [9] - The drug is also approved in combination with Kyprolis and dexamethasone for relapsed/refractory multiple myeloma patients with 1-3 prior lines of therapy [10]

Sarclisa Approval in China - Sarclisa, an anti-CD38 medicine, has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) in combination with pomalidomide and dexamethasone (Pd) [1] - The approval is based on the pivotal ICARIA-MM phase 3 study and the China-based IsaFiRsT real-world study, which demonstrated a 40% reduction in the risk of disease progression or death and a 6.9-month improvement in overall survival (OS) compared to Pd alone [2] - The IsaFiRsT study showed an overall response rate (ORR) of 82.6% among R/R MM patients [2] Clinical Studies and Results - The ICARIA-MM study enrolled 307 patients across 96 centers in 24 countries, with patients having received a median of three prior lines of therapy [6] - Sarclisa was administered intravenously at 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with Pd [7] - The primary endpoint was progression-free survival (PFS), with key secondary endpoints including ORR and OS [7] - The IsaFiRsT study enrolled 24 patients at one site in China, with a primary endpoint of ORR and key secondary endpoints including PFS, OS, and duration of response (DOR) [9][10] Regulatory and Guideline Recommendations - Sarclisa-Pd is included as a "Category I Recommendation" and "Preferred Option" in the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) guidelines for first-relapsed MM [4] - A regulatory submission for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) is under review in China [4] Sanofi's Commitment and Global Presence - Sanofi, one of the first multinational companies to enter China in 1982, is committed to accelerating the introduction of innovative medicines and vaccines in China [5] - Sarclisa is currently approved in more than 50 countries, including the US and EU, across multiple indications [12] - Sanofi is advancing Sarclisa through a patient-centric clinical development program, including phase 2 and phase 3 studies across six potential indications [13] Sarclisa Mechanism and Market Position - Sarclisa is a CD38 monoclonal antibody that induces antitumor activity through mechanisms such as apoptosis and immunomodulatory activity [11] - CD38 is highly expressed on multiple myeloma cells, making it a target for antibody-based therapeutics like Sarclisa [11] - Sanofi aims to become the leading immunoscience company globally, focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas [14]

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Sanofi (SNY) announced that the phase III IRAKLIA study, which evaluated a fixed-dose subcutaneous (SC) formulation of its blood cancer drug, Sarclisa (isatuximab) for the treatment of relapsed or refractory multiple myeloma (R/R MM) has met the co-primary endpoints.Data from the study showed that the new SC formulation of Sarclisa in combination with Bristol Myers’ (BMY) Pomalyst (pomalidomide) and dexamethasone (Pd) when administered through an on-body delivery system (OBDS) demonstrated non-inferiority i ...

Sanofi’s (SNY) stock has declined 10.2% in the past three months. However, a lot of this price decline was due to the downtrend of the overall drug and biotech sector, which performed poorly in the past three months after Trump announced the appointment of Robert F. Kennedy Jr., a vaccine skeptic, as the head of Health and Human Services, the agency that oversees the FDA.This, coupled with disappointing third-quarter sales and profits, guidance cuts and pipeline setbacks, took a toll on the overall drug and ...

Sanofi (SNY) and its partner SK bioscience announced that they have expanded their agreement to develop, license and commercialize next-generation pneumococcal conjugate vaccines (PCVs) for treating invasive pneumococcal disease (“IPD”) in pediatric and adult patient populations.The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize a 21-valent PCV (PCV21) for the pediatric patient population.Sanofi also said that the companies commenced a phase III p ...

Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines Pneumococcal disease remains a major global health challenge despite the availability of current vaccines This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants & toddlers Paris, December 23, 2024. Sanofi and SK bioscience have entered into a new chapter of thei ...