Press Release: New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma

Study Results - The IRAKLIA phase 3 study demonstrated that the subcutaneous (SC) formulation of Sarclisa, administered via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) Sarclisa in patients with relapsed or refractory multiple myeloma (R/R MM) [1] - Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions, and C trough at cycle 2, were also achieved [1] - The study enrolled 531 patients across 252 global sites, with patients randomized to receive either SC or IV Sarclisa in combination with Pd for 28-day cycles until disease progression or other discontinuation criteria were met [4] Subcutaneous Formulation and OBDS - The SC formulation of Sarclisa, delivered via the enFuse OBDS, represents a potential new administration option for patients, offering comparable efficacy and safety to the IV formulation [2] - The enFuse OBDS, developed by Enable Injections, is designed to administer high-volume medicines subcutaneously through an automated drug delivery technology, featuring a hidden and retractable needle that is thinner than commonly used SC injection needles [2][7] - The IRAKLIA study is the first global phase 3 study to evaluate the SC administration of a cancer treatment via an OBDS, aiming to improve the patient experience and reduce time spent in healthcare facilities [5] Regulatory and Clinical Development - Regulatory submissions for the SC formulation of Sarclisa are planned in the US and EU during the first half of 2025 [3] - Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing, with the safety and efficacy of the SC formulation and enFuse device yet to be evaluated by regulatory authorities outside of their approved indications [3][8] About Sarclisa - Sarclisa (isatuximab) is a CD38 monoclonal antibody that targets MM cells through multiple mechanisms of action, including apoptosis and immunomodulatory activity [8] - Currently approved in more than 50 countries, Sarclisa is indicated for the treatment of R/R MM in combination with Pd or carfilzomib and dexamethasone, and as a front-line treatment option for newly diagnosed MM in combination with VRd [8] Sanofi's Strategic Focus - Sanofi is committed to advancing oncology innovation, with a focus on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas, as well as gastrointestinal and lung cancers [9] - The company continues to advance Sarclisa as part of a patient-centric clinical development program, with several phase 2 and phase 3 studies across the MM treatment continuum [8][9]