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Treatment with fixed-dose subcutaneous Sarclisa plus Pomalyst and dexamethasone was non-inferior to IV Sarclisa in relapsed/refractory multiple myeloma.
Among patients with relapsed/refractory multiple myeloma, fixed-dose subcutaneous treatment with Sarclisa (isatuximab) in combination with Pomalyst (pomalidomide) and dexamethasone was non-inferior to treatment with intravenous (IV) Sarclisa, meeting the primary end point of the phase 3 IRAKLIA study, according to a press release.
Sarclisa was administered subcutaneously via an on-body delivery system (OBDS) in the investigational, randomized, open-label clinical trial and demonstrated that compared with IV treatment, patients treated with the subcutaneous formulation had non-inferior objective response rates (ORRs) and observed concentration before dosing (C trough) at steady state. The press release went on to share that key secondary end points, including very good partial response (VGPR), incidence rate of infusion reactions and C trough at cycle 2, were also achieved.
“The consistent ORR and comparable efficacy and safety profile observed in the IRAKLIA study for subcutaneous Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients,” said Dr. Sikander Ailawadhi, principal investigator of the study, in the news release. “The results from IRAKLIA, in patients with relapsed or refractory multiple myeloma, support the potential of an on-body delivery system to help ease the delivery of a new formulation without impacting patient outcomes.”
Intravenous (IV): when a needle is inserted into a vein to administer fluids or medications directly into the bloodstream.
Overall response rate: how many patients experienced a significant shrinkage or disappearance of their tumors after treatment.
Subcutaneous: beneath the skin.
Non-inferior: a new treatment is not significantly worse than a standard treatment by a predetermined margin.
C trough: the concentration reached by a drug immediately before the next dose is administered.
Ailawadhi is also a Professor of Medicine in the Division of Hematology/Oncology at the Mayo Clinic in Florida.
Additionally, the press release shared that the study is ongoing, and that full results will be presented at a forthcoming medical meeting.
A CD38 monoclonal antibody, Sarclisa binds to a specific epitope on the CD38 receptor on myeloma cells, ultimately inducing distinct antitumor activity, and is designed to work through multiple mechanisms of action. This includes programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is a target for antibody-based therapeutics such as Sarclisa.
The randomized, open-label, pivotal IRAKLIA study is evaluating the non-inferiority of subcutaneous Sarclisa administered at a fixed dose via an OBDS versus weight-based dosed IV Sarclisa, both in combination with Pomalyst and dexamethasone. The investigation has enrolled 532 patients with relapsed/refractory myeloma across 252 global sites. Eligible adult patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor, were equally randomized to receive either the subcutaneous or IV combination for 28-day cycles until disease progression, unacceptable side effects, participant request to discontinue therapy or any other reason, whichever came first.
Sarclisa was administered at a fixed dose in the subcutaneous arm for four weeks weekly during the first cycle followed by every two weeks for subsequent cycles. Comparatively, in the IV arm, Sarclisa was administered at a weight-based dose weekly for four weeks during the first cycle and every two weeks for subsequent cycles.
The co-primary outcomes of the investigation are ORR, defined as the proportion of patients with stringent complete response, complete response, VGPR and PR, and observed C trough at steady state, defined as observed Sarclisa plasma concentrations.
Notably, the press release notes that Enable Injections’ enFuse hands-free OBDS was used in the IRAKLIA study, which was designed to administer high-volume medicines subcutaneously through an automated drug delivery technology. A hidden and retractable needle is leveraged in the enFuse device that is thinner compared with commonly used subcutaneous injection needles. IRAKLIA is the first global phase 3 study to investigate the subcutaneous administration of a cancer therapy via an OBDS.
The press release went on to note that the safety and efficacy of subcutaneous Sarclisa and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications, though regulatory submissions in the U.S. and in the European Union are planned for the first half of 2025. Additional studies evaluating the subcutaneous formulation of Sarclisa across different combinations and lines of therapy are ongoing.
“We are fueled by our focus on innovation and finding best-in-class solutions to help ease the burden of disease for patients,” Dr. Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi, concluded in the press release. “The IRAKLIA study results are a prime example of what’s driving our scientific engine. Being able to possibly bring a novel option that helps reduce time in a healthcare facility is driven by our patient and provider-centric mindset. We look forward to sharing full results and working to bring this new advancement to the multiple myeloma community.”
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