Sanofi announces new data from two clinical studies on Sarclisa

New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously via an on-body injector in relapsed or refractory multiple myeloma support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa’s efficacy and safety profile. The results were presented at the American Society of Clinical Oncology Annual Meeting and include full data from the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, and demonstrate non-inferior efficacy and pharmacokinetics compared to Sarclisa intravenous infusion. The OBI offers the potential to improve the overall patient experience in MM treatment. Recent studies and surveys suggest the use of an OBI may be associated with greater convenience, flexibility, and patient satisfaction compared to IV or manual SC administration methods.1 In addition, an OBI may also streamline the administration process for providers, potentially reducing the physical burden on nurses and enabling them to possibly move freely through the use of a hands-free device while monitoring the patient during injection. The IRAKLIA phase 3 study and the IZALCO phase 2 study presented at ASCO were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector designed to subcutaneously administer high-volume medicines beginning with the click of a button, to administer the hyaluronidase-free SC formulation of Sarclisa. The enFuse device uses a 30 gauge, hidden, and retractable needle that is smaller compared to some of the commonly used large-volume SC injection needles, which may support patient comfort. The safety and efficacy of Sarclisa SC administered with the OBI or manual administration are investigational and have not been approved for use by any regulatory authority. IRAKLIA is a global, randomized, open-label, pivotal phase 3 non-inferiority study comparing Sarclisa SC administered via an OBI and Sarclisa IV, both in combination with pomalidomide and dexamethasone in adult patients with R/R MM who have received at least one prior line of treatment. At the data cut-off of November 6, 2024, and a median follow-up of 12 months, the study demonstrated: Primary endpoints: Objective response rate with Sarclisa SC-Pd was 71.1% compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority. Observed Sarclisa mean concentration before dosing at steady state with Sarclisa SC-Pd was 499 ug/mL compared to 341 ug/mL with Sarclisa IV-Pd, establishing non-inferiority. Secondary endpoints Very good partial response or better rates were consistent between Sarclisa SC-Pd and Sarclisa IV-Pd at 46.4% and 45.9%, respectively. Observed Sarclisa mean C trough at 4 weeks with Sarclisa SC-Pd was 421 ug/mL compared to 302 ug/mL with Sarclisa IV-Pd. Systemic infusion reactions were significantly lower with Sarclisa SC-Pd, occurring in only 1.5% of patients compared to 25% of those treated with Sarclisa IV-Pd. Of note, nearly all IRs occurring were grade 1 or 2 and resolved within one day. No patients in the Sarclisa SC-Pd arm discontinued treatment due to a systemic IR. Most Sarclisa SC-Pd-treated patients reported being satisfied or very satisfied with their injection compared to 53.4% in the Sarclisa IV-Pd arm, demonstrating the positive impact of this innovative method of administration on the patient experience. 99.9% of Sarclisa SC OBI injections were successfully delivered with no significant safety concerns related to the OBI. Progression-free survival rates at 12 months were also similar, reaching 66.1% for patients treated with Sarclisa SC-Pd compared to 65.1% of patients treated with Sarclisa IV-Pd. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd, but with a notably lower rate of systemic IRs. No new safety concerns were observed, except for low-grade local injection site reactions associated with SC administration that occurred with a low incidence. Nearly all ISRs were grade 1, except for one episode of grade 2.