SNY's Subcutaneous Sarclisa Proves Non-Inferior to IV Formulation (Revised)

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]