by Dr. C.H. Weaver M.D. 2/2019
A phase 3 comparative clinical trial evaluating isatuximab has met the primary endpoint of delaying cancer progression in patients with relapsed/refractory multiple myeloma.
Multiple myeloma is the second most common hematologic malignancy, with more than 138,000 individuals diagnosed worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden. (1,2)
Isatuximab is a precision cancer medicine that targets a specific part of the CD38 antigen expressed on myeloma cells and is capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumor cell death (apoptosis). CD38 is highly and uniformly expressed on multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics in multiple myeloma and other malignancies.
The current study evaluated the benefit of Isatuximab in combination with the standard of care on prolonging progression free survival as compared to standard of care in patients with relapsed/refractory multiple myeloma.
The study known as ICARIA-MM enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries to treatment with Pomalyst (pomalidomide) and dexamethasone with or without with the Isatuximab monoclonal antibody.
The therapy was generally well tolerated and the Isatuximab treated patients were reported to experience a delay in cancer progression.
The final results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.
Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.00.
Cowan AJ, Allen C, BaracA, et al. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4(9):1221–1227. doi:10.1001/jamaoncol.2018.2128