Patients Prefer At-Home Isatuximab Injector Over IV, IRAKLIA Data Show

New patient-reported outcomes data from the phase 3 IRAKLIA trial, presented at the 23rd International Myeloma Society (IMS) Annual Meeting, show that subcutaneous isatuximab delivered via an on-body injector (OBI) was preferred over intravenous (IV) administration across nearly every measure patients were asked about.¹

The findings arrive just months after the subcutaneous formulation received FDA approval in July 2026 based on this same trial—making this presentation less a first look at a new therapy and more a real-world validation of a delivery option pharmacists are likely already asking questions about.²

The Approval This Data Now Supports

The approval made isatuximab the first anticancer treatment in the US administered through both an OBI and manual subcutaneous injection, extending across all existing indications previously approved for the IV formulation, including combination use in transplant-ineligible newly diagnosed multiple myeloma and in relapsed/refractory multiple myeloma (RRMM) with pomalidomide-dexamethasone.^2,3

The pivotal, noninferiority IRAKLIA trial (NCT05405166) that supported that approval randomly assigned 531 patients with RRMM who received at least 1 prior line of therapy to isatuximab administered subcutaneously via OBI (1400-mg fixed dose) or via an IV (10 mg/kg weight-based), both combined with pomalidomide and dexamethasone. The trial met its coprimary end points, with an overall response rate of approximately 71.1% for the subcutaneous arm versus 70.5% for IV, along with comparable pharmacokinetic exposure and a shorter, more convenient administration time.⁴

“The secondary key end point of the study was patient satisfaction, and the major result … is that the satisfaction is quite much higher with the [subcutaneous route] than with IV. We also see less discomfort, less pain, and more time [saved]... Most patients can’t even notice that the needle goes in,” explained Fredrik Schjesvold, MD, PhD, founder and head of the Oslo Myeloma Center and head of the Norwegian myeloma association at Oslo University Hospital in Oslo, Norway.⁵

What the New Patient-Experience Data Adds

This IMS 2026 presentation is a dedicated patient-experience and satisfaction analysis layered on top of that already-approved efficacy and safety package. Among patients who reported being satisfied with their injection method at cycle 5, more patients on the subcutaneous OBI arm than the IV arm disagreed that their injection method was uncomfortable (78.7% vs 64.3%) or painful (89.1% vs 72.0%), and more reported fewer perceived medication adverse effects (AEs; 73.2% vs 55.9%).

Similar trends held in the “neutral” satisfaction subgroup. At end of treatment, a higher proportion of subcutaneous-arm patients felt treatment benefits outweighed disadvantages and expressed willingness to continue treatment (50.7% vs 31.4% for IV).¹

A separate at-home administration substudy within IRAKLIA further reinforced the practicality case: among patients eligible for at-home dosing by a health care provider starting at cycle 6, median injection time was comparable to in-clinic administration (12 vs 13 minutes), with a 100% completed injection rate and only 1 grade 1 injection-site reaction across 148 at-home injections analyzed.¹

"More patients treated with subcutaneous with the OBI reported positive experiences versus patients treated with [Isa] IV… More patients were willing to continue treatment [and] felt that benefits outweighed the disadvantages," said Schjesvold.⁵

What the OBI May Mean for At-Home Cancer Care

The at-home administration substudy is arguably the more consequential piece of this presentation for how myeloma care gets delivered going forward. That combination—equivalent administration time, no completion problems, and a safety profile that did not distinguish itself from the in-clinic experience—is the evidence base a health system needs before it will seriously consider moving a chronic anti-CD38 regimen out of the infusion chair. Some key takeaways for pharmacists include:

• Chair time and scheduling capacity: Every isatuximab dose that shifts to a home visit is chair time freed up for patients on regimens that still require IV infusion or closer monitoring—a real capacity lever for infusion centers already stretched by growing bispecific and CAR T-cell volumes.
• Patient burden and adherence: For patients managing transportation, work schedules, or mobility limitations, at-home administration removes a recurring logistical barrier that can otherwise erode adherence to maintenance-phase therapy over time.
• Oversight and triage protocols: Moving administration out of the clinic shifts the pharmacist's role. Health systems building at-home programs will need clear protocols for who administers the injection, how adverse events get triaged and reported back to the treating team, and at what point in therapy home dosing becomes appropriate to offer.
• Precedent beyond isatuximab: This is one of the first myeloma-specific at-home datasets for an anti-CD38 antibody delivered via OBI rather than manual subcutaneous injection, and it gives health systems already comfortable with at-home daratumumab programs a second agent and a second delivery technology to fold into the same infrastructure.

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.

2. Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. News release. Sanofi. July 10, 2026. Accessed September 25, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483

3. Jacobus N. FDA approves subcutaneous Sarclisa Escena for multiple myeloma. Pharmaceutical Executive. July 10, 2026. Accessed September 25, 2026. https://www.pharmexec.com/view/fda-approves-subcutaneous-sarclisa-escena-multiple-myeloma

4. Ailawadhi S, Špička I, Lu J, et al. Isatuximab (Isa) subcutaneous (SC) via an on-body delivery system (OBDS) vs Isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): results of the randomized, non-inferiority, phase 3 IRAKLIA study. J Clin Oncol. 2025;43(suppl 16):7506. doi:10.1200/JCO.2025.43.16_suppl.7506

5. Dimopoulos M, Morgan G, Visram A, et al. Poster discussion. International Myeloma Societty 23rd Annual Meeting and Exposition. September 23-26, 2026. Glasgow, Scotland.