SNY Sanofi

Sanofi explores combination treatments for multiple myeloma in new late-stage trials



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 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 meeting


Findings from additional ongoing studies of
isatuximab will be presented during poster sessions at this year’s
American Society of Hematology 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



About Sanofi



Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on human
health. We prevent illness with vaccines, provide innovative treatments
to fight pain and ease suffering. We stand by the few who suffer from
rare diseases and the millions with long-term chronic conditions.



With more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.



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. Learn more at www.sanofigenzyme.com.



Sanofi, Empowering Life



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07/12/2017
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