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On Thursday, Sanofi SA (NASDAQ:SNY) released results from the IRAKLIA phase 3 study evaluating the non-inferiority of Sarclisa (isatuximab) subcutaneous formulation via an on-body delivery system (OBDS) versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with relapsed or refractory multiple myeloma.
The trial demonstrated that Sarclisa SC, in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate and observed concentration before dosing (C trough) at steady state.
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Key secondary endpoints were also achieved, including very good partial response, the incidence rate of infusion reactions, and C trough at cycle 2.
The study is ongoing, and the full results will be presented at a forthcoming medical meeting.
Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing.
The safety and efficacy of Sarclisa SC and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications. Regulatory submissions in the US and in the EU are planned during the first half of 2025.
In September, the FDA approved Sarclisa (isatuximab) 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.
In August, Sanofi released new results from the GMMG-HD7 phase 3 study of Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible newly diagnosed multiple myeloma patients.
The data show that Sarclisa, combined with RVd during induction therapy, significantly prolonged progression-free survival, resulting in a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction regardless of the maintenance regimen.
Price Action: SNY stock closed at $49.23 on Wednesday.
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