IMS 2025: On-Body Injector for Isatuximab-Irfc Improves Patient Experience

Summary of the Interview with⁣ Dr.Xavier Leleu ⁣on Sarclisa On-Body Injector (OBI)

This interview with Dr.‍ Xavier Leleu discusses the findings ⁢from the IRAKLIA and ISASOCUT studies regarding the use of an on-body injector (OBI) for‍ administering Sarclisa (isatuximab) in patients with myeloma. Here’s a breakdown of the key points:

* Current Governance & Need for Improvement: Sarclisa is currently administered intravenously (IV), but this requires vein access, which can be challenging for ⁢some patients.While daratumumab successfully transitioned to‍ subcutaneous ⁢manual push, isatuximab presents challenges due to its thickness⁢ and volume.
* introducing the On-Body Injector (OBI): Sanofi developed a subcutaneous formulation of isatuximab delivered via an OBI – a small, automated device ⁤with a⁤ thin, hidden needle that retracts after injection. This aims to improve convenience, safety, and ⁤quality of‍ life for⁤ patients.
* IRAKLIA Study Findings: This phase 3, ‍non-inferiority study demonstrated that Sarclisa‍ could be⁢ effectively administered via the OBI at a flat dose of 1400mg. It met its two co-primary endpoints:
⁤ * Activity: ⁢ VGPR (Vrey Good Partial Response) rate was comparable to IV administration.
⁣ * Pharmacokinetics: C-trough levels (drug concentration in the blood) were similar between the OBI and IV routes.
* ISASOCUT Study: (Mentioned but not detailed) This study was also‍ conducted to support the registration of the OBI for Sarclisa.
* Benefits of OBI: The OBI offers a convenient, safe, and easy method of administration, especially for patients with difficult vein access, and improves the overall patient experience.

In essence, the ‍studies show that the OBI⁢ is a viable and effective alternative to IV administration of Sarclisa, offering significant benefits to patients.