Sanofi Genzyme Announces Start of Phase III Study of Isatuximab for Relapsed and Refractory Multiple Myeloma
December 05 2016 - 12:50PM
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.
Abstract: 2123Title: Preliminary Results From a
Phase Ib Study of Isatuximab in Combination with Pomalidomide and
Dexamethasone in Relapsed and Refractory Multiple
MyelomaPresenter: Dr. Paul Richardson
Abstract: 2111Title: Phase Ib Study of Isatuximab
and Carfilzomib in Relapsed and Refractory Multiple
MyelomaPresenter: Dr. Thomas Martin
Abstract: 2105Title: Critical Analysis of the
Mechanism of Action (MoA) of Isatuximab in Multiple
MyelomaPresenter: 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.
About Sanofi
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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