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Sanofi SNY announced that the phase III IRAKLIA study, which evaluated a fixed-dose subcutaneous (SC) formulation of its blood cancer drug, Sarclisa (isatuximab) for the treatment of relapsed or refractory multiple myeloma (R/R MM) has met the co-primary endpoints.
Data from the study showed that the new SC formulation of Sarclisa in combination with Bristol Myers’ BMY Pomalyst (pomalidomide) and dexamethasone (Pd) when administered through an on-body delivery system (OBDS) demonstrated non-inferiority in objective response rate (ORR) and observed concentration before dosing (C trough) as compared to currently approved intravenous (IV) formulation of Sarclisa administered at a weight-based dose in combination with Pd in the given patient population.
ORR and C trough were the two co-primary endpoints of the IRAKLIA study. It is also the first phase III study to evaluate the SC administration of a cancer drug via an OBDS
Per the company, OBDS is a substitute delivery method planned to improve the patient experience and currently available SC administration.
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More on SNY's Sarclisa New SC formulation
The IRAKLIA study also met its key secondary endpoints where treatment with Sarclisa SC formulation demonstrated very good partial response, incidence rate of infusion reactions and C trough at cycle two compared to Sarclisa IV infusion.
Full data from the open-label IRAKLIA study will be presented at an upcoming medical conference.
Sarclisa SC formulation is currently being evaluated in various other studies across different combinations and lines of therapy.
The regulatory filing seeking approval for the Sarclisa SC formulation is expected to be submitted in the United States and Europe during the first half of 2025.
Approved Indications of SNY's Sarclisa IV
Sarclisa, in combination with Bristol Myers’ Pomalyst and dexamethasone, is approved to treat adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The drug is also approved in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for treating patients with R/R MM who have received 1–3 prior lines of therapy. The drug is also approved for both these indications in the EU.
Both BMY’s Pomalyst and Revlimid are approved for multiple myeloma.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) in November 2024.