Sarclisa Subcutaneous Formulation Achieves Key Endpoints in IRAKLIA Phase 3 Multiple Myeloma Study

PARIS, France I January 9, 2025 I The IRAKLIA phase 3 clinical trial has revealed promising results for Sarclisa, a treatment for patients with relapsed or refractory multiple myeloma (R/R MM). Conducted with a focus on an innovative delivery method, this study examined the efficacy of Sarclisa when administered subcutaneously (SC) at a fixed dose using an on-body delivery system (OBDS). This method was compared against the traditional intravenous (IV) administration, which uses a weight-based dosage in combination with pomalidomide and dexamethasone (Pd).

The primary objectives of the study were successfully met, demonstrating that the SC administration of Sarclisa is non-inferior to the IV method in terms of objective response rate (ORR) and maintaining a steady observed concentration (C trough) before dosing. Additionally, the study achieved key secondary endpoints, such as very good partial response (VGPR) and managing infusion reactions effectively. These encouraging results will be shared in detail at an upcoming medical conference.

Dr. Sikander Ailawadhi, a leading investigator in the study and a Professor at the Mayo Clinic Florida, emphasized the significance of this breakthrough. He remarked that the consistent response rate and comparable safety profile of the SC Sarclisa could pave the way for a new administration option for patients. This advancement could ease the process of medication delivery without compromising patient outcomes.

The IRAKLIA study utilized Enable Injections' enFuse device, a hands-free OBDS designed to administer high-volume medications subcutaneously with an automated approach. The device features a hidden, retractable needle, thinner than standard SC injection needles, which enhances patient comfort during administration.

Dr. Houman Ashrafian, from Sanofi, highlighted the company's dedication to innovation and patient-centric solutions. He noted that the IRAKLIA study exemplifies the company's pursuit of scientific advancements aimed at reducing the burden of disease. Sanofi is eager to continue sharing these findings and to potentially introduce this advancement to the multiple myeloma community.

While additional studies on Sarclisa SC formulations are ongoing, the safety and efficacy of the SC method and enFuse device await evaluation by regulatory authorities outside of approved indications. Sanofi plans to submit regulatory applications in the US and EU in the first half of 2025.

The IRAKLIA study enrolled 531 patients globally, randomizing them equally to receive either Sarclisa SC or IV in combination with Pd over 28-day cycles until disease progression or the emergence of intolerable adverse events. The SC method involved a fixed dose weekly in the first cycle and bi-weekly thereafter, while the IV approach required weight-based dosing on a similar schedule. All participants had undergone at least one prior therapy line, including lenalidomide and a proteasome inhibitor.

Sarclisa, known scientifically as isatuximab, is a CD38 monoclonal antibody targeting the CD38 receptor prevalent on multiple myeloma cells. It works through several mechanisms, including inducing tumor cell death and modifying immune responses. Approved in over 50 countries, Sarclisa is utilized in different drug combinations to treat R/R MM and NDMM, with ongoing studies exploring further indications.

Sanofi's commitment to oncology innovation reflects its strategic focus on complex diseases like multiple myeloma and other hematologic cancers. Through a patient-centric development approach, Sanofi aims to address unmet medical needs and advance treatment options within the field of immunoscience.