On December 7, 2017 Sanofi reported that it 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 (Press release, Sanofi Genzyme, DEC 7, 2017, View Source [SID1234522429]).
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"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 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.
Other isatuximab data being presented at upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting
Findings from additional ongoing studies of isatuximab will be presented during poster sessions at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, December 8-12, in Atlanta, GA, including the following abstracts:
Saturday, December 9, 5:30 p.m.-7:30 p.m.:
Updated Results from a Phase Ib Study of Isatuximab Plus Pomalidomide (Pom) and Dexamethasone (dex) in Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract: 1887
Presenter: Dr. Paul Richardson
"In Vivo Vaccination" Effect in Clinical Responders to Anti-Myeloma Monoclonal Antibody Isatuximab
Abstract: 1830
Presenter: Dr. Tim Luetkens
Sunday, December 10, 6:00 p.m. -8:00 p.m.:
A Phase Ib Study of Isatuximab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (VCDI) in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation
Abstract: 3160
Presenter: Dr. Enrique M. Ocio
Pre-Clinical Efficacy of the Anti-CD38 Monoclonal Antibody (mAb) Isatuximab in Acute Myeloid Leukemia (AML)
Abstract: 2655
Presenter: Tomas Jelinek