OBI Rivals IV Isatuximab, Ups Patient Comfort

TOPLINE:

A novel, single-use on-body injector (OBI) for isatuximab in multiple myeloma is noninferior to the standard intravenous (IV) formulation in efficacy and pharmacokinetics and has no unexpected safety signals. 

METHODOLOGY:

• IRAKLIA is an ongoing study of administration methods of isatuximab as part of a triplet regimen that includes pomalidomide and dexamethasone, commonly used to treat people with relapsed or refractory multiple myeloma.
• A total of 263 IRAKLIA participants received isatuximab subcutaneously using the OBI, while 264 participants received isatuximab via IV formulation.
• After 1 year, investigators compared the overall response rate between the groups and found them to be similar.
• More participants who received the drug via OBI were satisfied (70.5%) with their injection method than those in the IV group (53.4%).

TAKEAWAY:

• IRAKLIA showed that the isatuximab subcutaneous OBI provided the same level of efficacy and pharmacokinetics as intravenous (IV) isatuximab, meeting noninferiority criteria.
• Patients who received the isatuximab subcutaneous OBI expressed higher satisfaction than those who received the IV formulation.
• The subcutaneous isatuximab OBI had a similar safety profile to IV isatuximab and no unexpected safety signals.
• Only 1.5% of patients in the OBI group had an infusion reaction compared to 25% in the IV group.

IN PRACTICE:

“These data support the isatuximab subcutaneous OBI as a standard-of-care administration for patients with multiple myeloma,” said investigator Xavier Leleu, MD, PhD, of Service d’Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402 in Poitiers Cedex, France. 

SOURCE:

Originally presented during an oral abstract session at the American Society of Clinical Oncology (ASCO) 2025 annual meeting, this study is in press at the Journal of Clinical Oncology.

LIMITATIONS:

The researchers did not gather patient satisfaction data until the fifth infusion. Because some patients had discontinued treatment by then, it’s possible that the findings underrepresent the level of patient satisfaction in the OBI group.

DISCLOSURES:

Leleu disclosed having relationships with AbbVie, Amgen, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Novartis, Oncopeptides, Roche, Sanofi, and Takeda.