Sanofi has shared positive results from a late-stage study investigating a subcutaneous formulation of its anti-CD38 therapy Sarclisa (isatuximab) in multiple myeloma (MM) patients.
The ongoing IRAKLIA study has been comparing SC Sarclisa, delivered at a fixed dose with Enable Injections’s on-body delivery system (OBDS), against weight-based doses of the drug’s approved intravenous (IV) formulation in adults with relapsed or refractory MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
SC Sarclisa in combination with pomalidomide and dexamethasone (Pd) met the study’s co-primary endpoints of non-inferior objective response rate and observed concentration before dosing at steady state compared to IV Sarclisa plus Pd.
Key secondary endpoints, including very good partial response and incidence rate of infusion reactions, were also achieved.
MM is the second most common haematological malignancy, with approximately 32,000 people in the US diagnosed with the disease every year. Despite available treatments, MM remains incurable and newly diagnosed patients have a five-year survival rate of about 52%.
Already approved in more than 50 countries to treat certain cases of relapsed refractory MM, Sanofi’s Sarclisa is designed to bind to a specific epitope on the CD38 receptor on MM cells and induce distinct anti-tumour activity.
The trial’s principal investigator, Sikander Ailawadhi, Mayo Clinic Florida, said: “The consistent overall response rate and comparable efficacy and safety profile observed in the IRAKLIA study for SC Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients.
“The results from IRAKLIA, in patients with relapsed or refractory MM, support the potential of an OBDS to help ease the delivery of a new formulation without impacting patient outcomes.”
Houman Ashrafian, executive vice president, head of research and development at Sanofi, said the company “[looks] forward to sharing full results and working to bring this new advancement to the multiple myeloma community”.
The announcement comes just over three months after IV Sarclisa was approved by the US Food and Drug Administration in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed MM patients who are not eligible for autologous stem cell transplant.