French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of this challenging disease.
Study Details and Results
The study achieved non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state, both co-primary endpoints, compared to intravenous (IV) Sarclisa administered at a weight-based dose in combination with pomalidomide and dexamethasone (Pd) in patients with relapsed or refractory multiple myeloma (R/R MM). Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions, and C trough at cycle 2, were also reached.
Previous Approvals and Milestones
Sarclisa (isatuximab) was approved in the US in September of last year in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a front-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). The CD38 monoclonal antibody (mAb) recently received regulatory approval in China for use in combination with pomalidomide plus dexamethasone in adult patients with multiple myeloma who have previously received at least first-line treatment, including lenalidomide and proteasome inhibitors.
IRAKLIA Study and Technology
The IRAKLIA study was conducted using Enable Injections’ enFuse hands-free OBDS, which was designed to administer high-volume medicines subcutaneously through an automated drug delivery technology. This innovative approach aims to improve patient convenience and treatment adherence.
Significance of the Study
The successful outcome of the Phase III IRAKLIA study underscores the potential of Sarclisa in subcutaneous administration, offering a more convenient and effective treatment option for patients with multiple myeloma. This development highlights Sanofi’s commitment to advancing innovative therapies and improving patient outcomes in oncology.-Fineline Info & Tech
