Sanofi Launches Phase 3 Trials To Evaluate Isatuximab In Multiple Myeloma
(RTTNews.com) - Sanofi (SNYNF) announced the company has launched two new late-stage clinical studies to determine if isatuximab (an anti-CD38 antibody), 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.
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.
The company said 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.
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