Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]
Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector