SNY's Subcutaneous Sarclisa Outperforms IV Formulation in Cancer Study

Core Viewpoint - Sanofi's phase III IRAKLIA study for the subcutaneous formulation of Sarclisa has successfully met its co-primary endpoints, indicating potential for improved treatment options in relapsed or refractory multiple myeloma [1][3]. Study Results - The study demonstrated that the new subcutaneous formulation of Sarclisa, when combined with Bristol Myers' Pomalyst and dexamethasone, showed non-inferiority in objective response rate (ORR) and observed concentration before dosing (C trough) compared to the intravenous formulation [2]. - The IRAKLIA study also met key secondary endpoints, showing very good partial response and a favorable incidence rate of infusion reactions at cycle two compared to the intravenous formulation [4]. Future Developments - The regulatory filing for the Sarclisa subcutaneous formulation is expected to be submitted in the United States and Europe in the first half of 2025 [5]. - Full data from the IRAKLIA study will be presented at an upcoming medical conference, which may provide further insights into the drug's efficacy and safety [4]. Market Context - Sanofi's shares have declined by 6.2% over the past year, while the industry has seen a decrease of 2.2%, indicating a relative underperformance in the market [3].