CAMBRIDGE: Sanofi has launched two new late-stage clinical studies to determine if an investigational biologic called isatuximab when used in combination with other commonly used cancer treatments, might be an effective treatment option for certain people with multiple myeloma, a rare blood cancer related to lymphoma and leukemia.
Isatuximab is an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with relapsed and previously untreated multiple myeloma.
“The start of two new Phase 3 trials will provide further clinical data as we continue to advance the development of isatuximab,” said Joanne Lager, M.D. Head of Oncology Development, Sanofi.
“Our multi-study program across major multiple myeloma segments aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens. We are committed to developing a potential new treatment option for a continuum of patients with multiple myeloma, a population with high unmet need.”
Late-stage studies include approximately 750 patients with multiple myeloma
- IKEMA study is a 325-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with carfilzomib and dexamethasone against carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma that have previously been treated with one-to-three lines of therapy.
- IMROZ study is a 425-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with bortezomib, lenalidomide and dexamethasone against bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients not eligible for transplant.
Both studies will evaluate progression-free survival as the primary endpoint. Key secondary endpoints include overall survival, overall response rate, depth of response, safety and quality of life.
Isatuximab granted orphan designation
Isatuximab has been granted orphan designation in the U.S. and the European Union. In December 2016, Sanofi started an additional Phase 3 study (ICARIA), comparing isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. The development program for isatuximab will now total three Phase 3 studies.