French pharma giant Sanofi has unveiled that its multiple myeloma drug isatuximab has met its primary endpoint of prolonged progression-free survival in a Phase III trial.
The randomised, multi-centre, ICARIA-MM trial evaluated the benefit of isatuximab in combination with the standard of care for multiple myeloma, pomalidomide and a low dose of dexamethasone, in comparison with the standard of care alone.
All participants in the study had been treated with two or more prior therapies, meaning their melanoma was relapsed and refractory. The drug is administered through an intravenous injection every week for four weeks than every other week in 28-day cycles.
Isatuximab is a humanised immunoglobulin G monoclonal antibody that targets a specific epitope of CD38; this glycoprotein is highly and uniformly expressed on multiple myeloma. Its mechanism of actions is suspected to trigger various types of cytotoxicity, as well as inhibit enzymatic activity and apoptosis leading to cell lysis in CD38-expressing tumour cells.
The ICARIA-MM study is the first time a monoclonal antibody has been tested for efficacy in this disease with this standard of care.
Sanofi head of research and development John Reed said: “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients.
“We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.”
Results from the ICARIA-MM trial will be presented soon and are expected to be used as a basis for regulatory submission planned for later in 2019.
The drug already has orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency.
Isatuximab is being investigated in three other Phase III trials for various stages of multiple myeloma patients in combination with standard of care therapies. It is also being studied in Phase II trials in combination with another Sanofi drug in development, cemiplimab, for advanced malignancies and relapsed refractory myeloma.