The European Commission (EC) has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with Multiple Myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. Sarclisa is the first anticancer therapy in the EU to be administered through an On-Body Injector (OBI) and manual SC administration and can provide the flexibility of administration at patients’ homes and in the outpatient setting.

Mohamad Mohty, MD, PhD, Professor of Hematology, Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department, Saint-Antoine Hospital, Paris, France, said, “Multiple Myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey. The ability to administer a therapy through an On-Body Injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care.”

Since launching in 2020, Sarclisa has been prescribed to patients worldwide. Sarclisa IV is currently approved across 4 indications in the EU, including in combination with bortezomib, lenalidomide, and dexamethasone in both transplant-ineligible newly diagnosed MM (NDMM, TI) and transplant-eligible NDMM (NDMM, TE).

In relapsed and/or refractory (R/R) MM, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib and dexamethasone. The approval of Sarclisa SC, which follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), is based on the results from the pivotal IRAKLIA phase 3 study in R/R MM (NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as additional studies.

Olivier Nataf, Global Head of Oncology, Sanofi, said, “Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered. Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today’s EU approval, we’re combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ On-Body Injector, which could offer a meaningful difference in the treatment experience.”

The IRAKLIA and IZALCO studies suggest the use of an OBI may be associated with greater simplicity, flexibility, convenience and patient satisfaction compared to IV, and that patients and Health Care Providers (HCPs) prefer the OBI compared to manual SC administration.

In the IRAKLIA phase 3 study, 70 percent of patients treated with Sarclisa SC administered via an OBI reported being satisfied or very satisfied with their injection compared to 53.4 percent patients receiving Sarclisa IV (OR 2.036; 95 percent CI: 1.425-2.908; p=0.0001).

In the IZALCO phase 2 study, after experiencing both administration methods, 74.5 percent of patients preferred Sarclisa SC administered via an OBI over manual injection, compared with only 17 percent who preferred manual injection and 8.5 percent with no preference (p=0.0004; binomial test against the null hypothesis of <50 percent rate), reinforcing strong patient preference for simplified, hands-free administration.

Sarclisa will be used in conjunction with Enable Injections’ CirCLIQ OBI, an automated injector developed using the enFuse platform, designed to subcutaneously deliver Sarclisa with the push of a button in either outpatient or home settings. Sarclisa SC administered via the CirCLIQ OBI uses a hidden retractable needle that is shorter and thinner compared to the needles commonly used for large-volume SC injections.

In the IRAKLIA study, the first phase 3 study to incorporate the use of an OBI in the treatment of MM, Sarclisa SC administered via an OBI in combination with Pd resulted in a 71.1 percent Objective Response Rate (ORR), compared to 70.5 percent with Sarclisa IV-Pd, establishing non-inferiority (Risk Ratio [RR]: 1.008; 95 percent Confidence Interval [CI]: 0.903-1.126; p=0.0006), in adult patients with R/R MM who have received at least one prior line of treatment.

The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25 percent of patients treated with Sarclisa IV-Pd experienced systemic infusion reactions, 1.5 percent of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local Injection Site Reactions (ISRs) that occurred in .4 percent of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common grade ≥3 nonhematologic Adverse Events (AEs) were pneumonia (14.8 percent OBI, 15.5 percent IV), COVID-19 (2.7 percent, 1.9 percent), and upper respiratory tract infection (1.5 percent both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7 percent OBI, 74.3 percent IV), thrombocytopenia (26.1 percent, 23 percent) and anemia (17.6 percent, 19.5 percent).

In patients from countries where at-home administration was permissible, median injection duration with Sarclisa SC via an OBI was the same between clinic and at-home administration (13 minutes). Home administration was well tolerated with no new safety signals and all injections were completed.