The IRAKLIA trial (NCT05405166) compared subcutaneous (SC) vs intravenous (IV) administration of Isatuximab (Isa) combined with Pomalidomide (Pd) in relapsed/refractory multiple myeloma (RRMM). Conducted with an investigational wearable injector, results demonstrated comparable efficacy (71% overall response rate) and pharmacokinetic profiles between Isa SC and IV, with significantly lower incidence of infusion reactions and higher patient satisfaction for SC administration.

Key Points:

• Research Problem/Question: Compare Isa SC vs IV + Pd in RRMM patients.
• Methodology: Multicenter, open-label Phase 3 trial (IRAKLIA; NCT05405166).
• Key Findings: Comparable efficacy (71% ORR), pharmacokinetics, and safety profiles; lower infusion reaction rates and higher patient satisfaction with SC Isa administration.
• Significance/Impact: Supports Isa SC as a viable alternative with enhanced patient experience and practice efficiency.

Conclusion:
The IRAKLIA trial establishes Isa SC as non-inferior to IV administration in RRMM treatment, highlighting improved tolerability and patient satisfaction with the investigational wearable injector.

Authors:
Sikander Ailawadhi, Ivan Spicka, Jin Lu, Albert Oriol, Silvia Ling, Fredrik Schjesvold, Alejandro Berkovits, Marek Hus, Meletios Dimopoulos, Peter Rajnics, Vania Hungria, Maria del Rosario Custidiano, Gurdeep Parmar, Xavier Leleu, Tondre Buck, Jiri Minarik, Rick Zhang, Dorothee Semiond, Maya Stefanova-Urena, Philippe Moreau.

Clinical Trial Registration Number: NCT05405166
DOI: 10.1200/JCO.2025.43.16_suppl.7506
Abstract #7506