Sanofi: positive data for Sarclisa subcutaneous
(CercleFinance.com) - Sanofi announces that the new subcutaneous formulation of its Sarclisa product has met the primary endpoints of the Phase III IRAKLIA study in relapsed or refractory multiple myeloma.
In combination with pomalidomide and dexamethasone, it demonstrated non-inferiority in objective response rate and minimum observed steady-state concentration, compared with intravenous Sarclisa.
Key secondary endpoints were also met, in particular the very good partial response rate, the incidence rate of injection reactions and the minimum concentration at cycle 2.
The study is ongoing, and full results will be presented at a forthcoming medical congress. Regulatory submissions are planned for H1 2025 in the US and EU.
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