CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sanofi Genzyme, the specialty care global business unit of Sanofi, today announced the initiation of the ICARIA-MM Phase III trial of isatuximab, an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with relapsed and refractory multiple myeloma. The trial will compare isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone.
The primary endpoint of the study is progression-free survival. Key secondary endpoints include overall response rate and overall survival. The randomized, open label study will enroll 300 patients at trial sites around the world. Isatuximab has been granted orphan designation in the U.S. and European Union.
“The start of this trial is an important step in our effort to develop a new option for patients with multiple myeloma,” said Joanne Lager, Head of Oncology Development, Sanofi. “The development of isatuximab is a priority for us. “We are committed to advancing this study as quickly as possible and investigating the expanded use of isatuximab in multiple myeloma and additional malignancies.”
The initiation of Phase III development for isatuximab is supported by encouraging Phase I and II clinical trial results. Anti-CD38 mAbs are recognized by myeloma experts as an important class of therapies for the treatment of multiple myeloma.
Findings from studies of isatuximab were presented during a poster session on Saturday, December 3rd at this year’s American Society of Hematology meeting underway in San Diego, including the following abstracts.
Title: Preliminary Results From a Phase Ib Study of Isatuximab in Combination with Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Presenter: Dr. Paul Richardson
Title: Phase Ib Study of Isatuximab and Carfilzomib in Relapsed and Refractory Multiple Myeloma
Presenter: Dr. Thomas Martin
Title: Critical Analysis of the Mechanism of Action (MoA) of Isatuximab in Multiple Myeloma
Presenter: Dr. Bruno Paiva
About Multiple Myeloma
The second most common cancer of the blood, multiple myeloma is a cancer that starts in plasma cells, a type of white blood cell. In time, myeloma cells collect in the bone marrow. They may damage the solid part of the bone, and eventually harm other tissues and organs, such as the kidneys. Worldwide, nearly 230,000 people are living with multiple myeloma, and each year, approximately 114,000 new cases are diagnosed.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
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Bo Piela, Head of Communications