Dr Leleu on QOL Outcomes With SC Isatuximab Via On-Body Delivery in R/R Myeloma

“The quality of life was so much better [with SC ixatuximab], but specifically for the patients [who were treated in the] isatuximab on-body delivery arm.”

Xavier Leleu, MD, PhD, head of the Department of Haematology and the Myeloma Clinic at Hôpital La Mileterie in Poitiers, France, discussed findings from the phase 3 IRAKLIA study (NCT04644632), which compared subcutaneous (SC) isatuximab-irfc (Sarclisa) delivered via an on-body delivery (OBD) system with intravenous (IV) isatuximab, each administered in combination with pomalidomide and dexamethasone (Isa-Pd), in patients with relapsed/refractory multiple myeloma. During the study, patients were randomized to receive either the IV or subcutaneous formulation, with the latter given as a fixed flat dose through the OBD platform.

The trial was designed with two co-primary end points: clinical activity and pharmacokinetics. Noninferiority was demonstrated for both end points, Leleu said. Rates of very good partial response (VGPR) or better at 8 months were comparable between the 2 arms, meeting the activity endpoint. Pharmacokinetic analysis showed that trough concentrations at cycle 6 were consistent between the groups and, in some cases, slightly higher with the SC formulation, he added.

Regarding secondary end points, quality of life (QOL) outcomes were particularly noteworthy. Leleu highlighted that patients treated in the OBD arm reported higher levels of treatment satisfaction compared with those in the IV arm. Not only did more patients describe themselves as satisfied, but a greater proportion in the OBD group reported being very satisfied. This improvement in patient-reported QOL was observed despite comparable efficacy and pharmacokinetic results between the treatment groups.

Safety outcomes were consistent across both study arms, with no new or unexpected signals reported. The tolerability profile of SC isatuximab via OBD mirrored that of IV administration, with similar rates of treatment-emergent adverse effects (TEAEs) and no increase in treatment discontinuations. Importantly, the safety profile of the subcutaneous formulation was not compromised, further supporting its potential integration into routine practice, Leleu explained.

Leleu concluded that the IRAKLIA study supports SC isatuximab via OBD as a clinically meaningful alternative to IV administration for patients with relapsed/refractory multiple myeloma receiving Isa-Pd. By providing equivalent efficacy and pharmacokinetics while significantly enhancing QOL, the OBD formulation represents an important advancement in the delivery of isatuximab, he said.