French pharmaceutical company Sanofi has reported results from its Phase III IRAKLIA trial, which evaluated Sarclisa (isatuximab) as a potential treatment for multiple myeloma (MM).
The trial enrolled 531 adult subjects with MM who had received at least one previous line of therapy, including lenalidomide and a proteasome inhibitor, across 252 sites worldwide.
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It met its co-primary endpoints when Sarclisa was administered subcutaneously using an on-body delivery system (OBDS) combined with pomalidomide and dexamethasone (Pd).
The study demonstrated a non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at a steady state against the intravenous form of the therapy combined with Pd in subjects with relapsed or refractory MM.
The randomised, open-label trial showed that the therapy also achieved key secondary endpoints, which included ‘very good’ partial responses, incidence infusion reaction rates, and C trough at cycle two.
Sanofi plans to submit regulatory filings in the US and European Union in the first half of this year, following additional ongoing studies of Sarclisa’s subcutaneous formulations across various combinations and lines of therapy.
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By GlobalDataThe therapy’s efficacy and safety has yet to be evaluated by regulatory authorities beyond currently approved uses.
Sanofi Research and Development head and executive vice-president Houman Ashrafian said: “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.”
Sarclisa is a CD38 monoclonal antibody that targets the CD38 receptor on MM cells, inducing apoptosis and immunomodulatory activity.
In December 2023, Sanofi reported that its Phase III IMROZ trial of Sarclisa in combination with standard-of-care treatment for MM met its primary endpoint.
