Subcutaneous Isatuximab Enhances Patient Experience in Multiple Myeloma

Subcutaneous isatuximab-irfc (Sarclisa Escena) delivered via a novel on-body injector (OBI) was associated with higher patient satisfaction and more positive treatment experiences than intravenous isatuximab among those with relapsed/refractory multiple myeloma, according to a patient-reported outcomes (PRO) and subgroup analysis from the phase 3 IRAKLIA trial (NCT05405166) presented in a poster session at the 23rd Annual International Myeloma Society (IMS) Meeting & Exposition.¹

What did the patient-reported outcomes show?

At cycle 5, day 15, patients treated with subcutaneous isatuximab via OBI reported higher satisfaction (96.8% vs 70.8%) and greater time savings (83.1% vs 32.7%) than those treated with intravenous isatuximab, along with numerically lower rates of discomfort (13.8% vs 16.3%) and pain (6.9% vs 10.4%). In subgroup analyses based on the Patient Experience and Satisfaction Questionnaire Follow-Up, a higher proportion of patients in the OBI arm disagreed or strongly disagreed that the injection method was uncomfortable (78.7% vs 64.3% among satisfied patients) or painful (89.1% vs 72.0% among satisfied patients) compared with the intravenous arm.

A higher proportion of patients in the OBI arm also disagreed or strongly disagreed that the medication resulted in adverse effects (73.2% vs 55.9% among satisfied patients). The investigators reported that more patients treated with the OBI reported positive experiences than those treated with intravenous isatuximab across both the satisfied and neutral subgroups.

What did the end-of-treatment analysis show?

At the end of treatment, patients completed the Patients’ Assessment of Treatment questionnaire evaluating their perception of treatment benefits relative to disadvantages and their willingness to continue treatment. A total of 45.5% of patients in the subcutaneous isatuximab OBI arm reported high benefits and low disadvantages, compared with 40.0% in the intravenous arm. A greater proportion of patients in the OBI arm expressed willingness to continue treatment and felt that the benefits outweighed the disadvantages (50.7% vs 31.4% in the IV arm). The investigators noted that this difference occurred despite no difference in patient-reported levels of benefits and disadvantages between the 2 administration methods.

“Our findings further demonstrate positive patient experience, comfort, and overall satisfaction with the OBI as a novel method for [subcutaneous] delivery of [isatuximab], consistent with results from the overall IRAKLIA cohort,” presenting study investigator Fredrik Schjesvold, MD, PhD, head of the Oslo Myeloma Center at Oslo University Hospital, wrote with coauthors in the poster.¹

What is the IRAKLIA trial design?

IRAKLIA is a noninferiority phase 3 trial that randomly assigned 531 adults with relapsed/refractory multiple myeloma who had received at least 1 prior line of therapy 1:1 to subcutaneous isatuximab via OBI at 1400 mg (n = 263) or intravenous isatuximab at 10 mg/kg (n = 268), each given weekly in cycle 1 and then every 2 weeks, plus pomalidomide (Pomalyst) and dexamethasone.Randomization was stratified by multiple myeloma isotype, body weight, and number of prior lines of therapy.

The co-primary end points were overall response rate and the predose trough concentration of isatuximab at cycle 6, day 1, with patient satisfaction with the delivery method as a key secondary end point. All PRO analyses were performed in the intention-to-treat population of 531 patients; the satisfied and neutral subgroups were defined by patient responses at cycle 5, day 15, while the dissatisfied subgroup was excluded from the subgroup analysis because of its small sample size. The baseline age (median, 66 years) and body weight were balanced between arms.

What is the significance of these findings?

The OBI enables hands-free administration of isatuximab with a small, hidden, retractable needle and simple one-step vial-to-device preparation. In July 2026, the FDA approved subcutaneous isatuximab in combination with other therapies as the first anticancer treatment to be administered via an OBI based on data from the IRAKLIA trial.²

References

1. Ling S, Špička I, Oriol A, et al. Evaluation of patient-reported outcomes and subgroup analysis with subcutaneous isatuximab delivered via on-body injector compared with intravenous delivery from the phase 3 IRAKLIA trial. Presented at: 23rd International Myeloma Society Annual Meeting; September 23-26, 2026; Glasgow, Scotland. Poster PA-185.
2. FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. News release. FDA. July 9, 2026. Accessed September 26, 2026. https://tinyurl.com/4cccdbpn