On June 19 local time, Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved the subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM).
The approved indications for Sarclisa SC in Japan include: in combination with pomalidomide and dexamethasone (Pd), or in combination with carfilzomib for the treatment of relapsed or refractory multiple myeloma (R/R MM), and in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).
In addition, a regulatory application for the enFuse platform-based CirCLIQ on-body injector (OBI), submitted by Enable Injections, is currently under review in Japan. This is an auto-injection device intended for subcutaneous administration of Sarclisa. If approved, Sarclisa SC may become the first anti-cancer therapy administered via an on-body injector and the first multiple myeloma drug in Japan to offer both manual subcutaneous injection and on-body injector administration options.
This approval is based on positive results from the Phase 3 IRAKLIA study (NCT05405166), which demonstrated comparable efficacy between the subcutaneous and intravenous formulations, along with supporting studies. In addition to manual subcutaneous injection, these studies also evaluated Sarclisa SC administered via the on-body injector (OBI).
In the IRAKLIA study, in adult patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, the objective response rate (ORR) for Sarclisa SC administered via OBI in combination with pomalidomide and dexamethasone (Pd) was 71.1%, compared with 70.5% for intravenous Sarclisa plus Pd, demonstrating non-inferiority of the SC formulation to the IV formulation (risk ratio: 1.008; 95% CI: 0.903–1.126; p = 0.0006).
The overall safety profile of Sarclisa SC plus Pd observed in this study was consistent with the established safety profile of intravenous Sarclisa plus Pd. Infusion reactions occurred in 25% of patients receiving intravenous Sarclisa plus Pd, compared with 1.5% of patients receiving subcutaneous Sarclisa plus Pd.
No new safety concerns were observed, aside from mild local injection site reactions (ISRs) occurring in 0.4% of on-body injector administrations (n=19/5,145 injections). Nearly all injection site reactions were Grade 1, with only one Grade 2 event.
Multiple myeloma is the third most common hematological malignancy in Japan. In Japan, the intravenous formulation of Sarclisa is currently approved for five indications, including in combination with VRd for newly diagnosed multiple myeloma (NDMM), and for four different treatment regimens for relapsed/refractory multiple myeloma (R/R MM) — in combination with Pd, in combination with carfilzomib and dexamethasone (Kd), in combination with dexamethasone alone, or as monotherapy.
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