Sanofi Announces A New Way To Administer Isatuximab (Sarclisa) That Reduces Side Effects

Patients with relapsed or refractory multiple myeloma may soon have a new, more convenient way to receive isatuximab (Sarclisa, Sanofi), a therapy already approved for use in combination with other medications. Recent study findings presented at the ASCO 2025 meeting support the investigational use of Sarclisa as a quick subcutaneous injection delivered through a new on-body injector device called enFuse®.

A New Way to Receive Isatuximab (Sarclisa)

Two clinical trials; IRAKLIA (phase 3) and IZALCO (phase 2), evaluated how well isatuximab works and how safe it is when given subcutaneously using a wearable injector, compared to the traditional intravenous (IV) method. The new method uses a small, hands-free device called enFuse® (Enable Injections), which delivers the medication under the skin with the push of a button.

In the IRAKLIA study, researchers compared subcutaneous isatuximab in combination with pomalidomide and dexamethasone to the same combination using IV isatuximab. Both groups included adults with relapsed or refractory multiple myeloma who had received at least one prior therapy. Results showed:

• 71% of patients in both studies responded to treatment
• The 12-month progression-free survival (PFS) was nearly the same between groups, with over 65% of patients achieving it. 
• Side effects were diminished, as only 1.5% of patients in the subcutaneous group
• 70% of patients preferred the subcutaneous injection compared to 53.4% in the IV group.

These findings offer clear benefits for patients, including a more convenient way of administering a medication, while reducing side effects and still achieving great results.

Why this new advancement matters for patients 

The enFuse® device uses a small needle that stays hidden and retracts after use. This may reduce discomfort and anxiety. The injection process also takes just minutes and requires little involvement from healthcare staff, freeing up time for both patients and providers. In the IRAKLIA study, 99.9% of injections using the device were completed successfully with no serious issues.

Reducing treatment time and making administration easier can improve quality of life, especially for people who receive frequent therapy. It may also reduce strain on nursing staff and allow for more flexible care settings.

Supporting evidence from a second study: IZALCO 

The IZALCO phase 2 study included patients who received Sarclisa with carfilzomib and dexamethasone. Patients were treated either via manual subcutaneous injection or the wearable on-body injector. At a median follow-up of 10 months:

• The response rate was 79.7%
• A very good partial response or better occurred in 62.2% of patients
• Complete response or better was reported in 21.6%
• Infusion reactions occurred in only 2.7% of patients receiving manual injections and none in the on-body injector group
• 74.5% of patients preferred the on-body injector over manual injection

This second study confirms that the on-body device offers a convenient and effective alternative to other methods, with strong patient preference and minimal side effects.

Looking Ahead

The on-body injection method is still investigational and not yet approved for use. However, based on the positive findings from IRAKLIA and IZALCO, the manufacturer Sanofi is preparing to seek global regulatory approval.

Further studies are also exploring the use of the device in newly diagnosed patients. The goal is to expand this faster, easier treatment option to a broader range of patients in the future.

Take-home message

These studies show that subcutaneous isatuximab delivered via a wearable injector works just as well as IV infusion, with fewer reactions and greater patient satisfaction. For people living with multiple myeloma, this could offer a more comfortable and less time-consuming treatment experience in the future.

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Sources:

• Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
• 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.
• Efficacy and safety of isatuximab subcutaneous (SC) plus carfilzomib and dexamethasone (Isa-Kd) in patients with relapsed/refractory multiple myeloma (RRMM): Results of the phase 2 study IZALCO.