French pharmaceutical giant Sanofi recently announced that the key phase III clinical study ICARIA-MM to evaluate isatuximab in the treatment of recurrent/refractory multiple myeloma (R/R MM) has reached the main end point. The study, a randomized, multicenter, open-label study conducted in 96 centers in 24 countries, enrolled 307 patients with R/R MM who had previously received two or more types of anti-myeloma therapy. The results showed that isatuximab combined with standard nursing significantly prolonged the progression-free survival time (PFS) compared with standard nursing (pomalidomide & low-dose dexamethasone). Details of the study will be presented at an upcoming medical conference and will serve as a basis for regulatory filings scheduled for later this year.
ICARIA-MM is one of four phase III clinical studies being carried out by Sanofi, which are evaluating isatuximab combined with currently available standard therapies for the treatment of R/R MM patients or newly diagnosed MM patients. “We are excited about these results, which represent important progress in prolonging the lives of MM patients,” said John Reed, head of research and development at Sanofi, “we look forward to working with regulators to bring this potential new treatment to patients as soon as possible.”
Multiple myeloma (MM) is the second most common malignant tumor of the blood system. Globally, more than 1.38 million people suffer from the disease each year. For most patients, MM is still incurable, so there are significant unmet medical needs in this area.
Isatuximab (SAR650984) is an IgG1 chimeric monoclonal antibody targeting a specific epitope of CD38, which can trigger a variety of unique mechanisms, including promoting programmed cell death (apoptosis) and immunomodulatory activity. CD38 is highly expressed in MM cells and is a cell surface receptor target for antibody therapy in MM and other malignant tumors. In the United States and the European Union, isatuximab has been granted orphan drug qualifications for the treatment of R/R MM. Sanofi is also assessing the potential of isatuximab in the treatment of other hematological malignancies and solid tumors.