How On-Body Treatment Delivery Reduces Nursing Burden in Myeloma Care

In the second episode of a special Oncology Nursing News podcast series, Beth Faiman, PhD, MSN, APN-BC, AOCN, FAAN, FAPO, of Cleveland Clinic, and Sikander Ailawadhi, MD, of Mayo Clinic, discussed the structural innovations of on-body delivery systems in multiple myeloma care.

The discussion followed the U.S. Food and Drug Administration (FDA) approval of subcutaneous isatuximab-irfc (Sarclisa Escena) administered via the CirCLIQ on-body delivery system (OBDS) across approved multiple myeloma indications23. Approved indications include combination regimens with pomalidomide and dexamethasone (Pd) for relapsed or refractory multiple myeloma (RRMM) after at least one prior line of therapy, carfilzomib and dexamethasone (Kd) for RRMM, and bortezomib, lenalidomide, and dexamethasone (VRd) for transplant-ineligible newly diagnosed disease.

Addressing provider strain and patient experience in oncology care, Ailawadhi previously emphasized that multiple myeloma treatment "often requires frequent IV infusions or manual subcutaneous injections," noting that manual administration places "a strain on providers by requiring physical effort to push high-resistance syringes for several minutes." Traditional manual subcutaneous pushes require constant, steady pressure over several minutes, whereas the automated OBDS provides hands-free delivery, eliminating manual pressure demands and freeing nurses for other clinical tasks.

Approval of the on-body system was supported by data from the randomized Phase III IRAKLIA trial (NCT05405166), evaluating subcutaneous isatuximab-irfc via OBDS against intravenous isatuximab-irfc in 531 patients with RRMM9. The trial met its coprimary endpoints of efficacy and pharmacokinetic noninferiority, demonstrating an overall response rate (ORR) of 71.1% (95% CI, 65.2–76.5) in the subcutaneous OBDS arm compared with 70.5% (95% CI, 64.7–75.9) in the intravenous arm (relative risk, 1.008; 95% CI, 0.903–1.126).

Phase II supporting studies IZALCO (NCT05704049) and IsaSoCut (NCT05889221) achieved ORRs of 79.7% and 97.3%, respectively. Subcutaneous administration via OBDS yielded a 17-fold reduction in systemic administration reactions compared with intravenous administration (1.5% vs 25.0%; P < .0001). The hands-free device demonstrated 99.9% delivery completion without interruption across 5,145 injections, with a median administration duration of 13 minutes. Local injection site reactions occurred in 0.4% of OBDS injections, all Grade 1 or 2.

Patient satisfaction, measured by the Patient Experience and Satisfaction Questionnaire at Cycle 5 Day 15, showed 70.0% of patients in the OBDS arm were satisfied or very satisfied versus 53.4% in the intravenous arm (P = .0001). The hands-free mechanism and smaller, retractable 30-gauge needle streamline outpatient workflow while alleviating patient needle phobia.

Supported in part by Sanofi, content independently developed by OncLive and Oncology Nursing News. The opinions are those of the faculty and do not reflect those of any company that provided support. Before administration, please see package insert.

References

1. FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. U.S. Food and Drug Administration. July 9, 2026. Accessed September 18, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications
2. Ailawadhi S, Špička I, Spencer A, et al. Isatuximab subcutaneous by on-body injector versus isatuximab intravenous plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Phase III IRAKLIA study. J Clin Oncol. 2025;43(22):2527-2537. doi:10.1200/JCO-25-00744 (NCT05405166)
3. Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector [press release]. Sanofi. July 10, 2026. Accessed September 18, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483