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

“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

  • 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

  • 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

    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


    Presenter: Dr. Enrique M. Ocio

  • Pre-Clinical Efficacy of the Anti-CD38 Monoclonal Antibody (mAb)
    Isatuximab in Acute Myeloid Leukemia (AML)

    Abstract: 2655

    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

Sanofi, Empowering Life

Sanofi Forward-Looking Statements

This press
release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These
statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities and/or obtain
regulatory clearances, risks associated with intellectual property and
any related pending or future litigation and the
ultimate outcome
of such litigation,
trends in exchange rates and prevailing
interest rates, volatile economic conditions, the impact of cost
containment initiatives and subsequent changes thereto, the average
number of shares outstanding as well as those discussed or identified in
the public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2016. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.

0 pages

Research Provider

Business Wire, acquired by Berkshire Hathaway in 2006, is the global market leader in commercial news distribution. Thousands of member companies and organisations depend on Business Wire to transmit their full-text press releases, regulatory filings, photos and other multimedia content to journalists, financial professionals, investor services, regulatory authorities and consumers worldwide. For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Read more


Consumer Non-Cyclical - France
Visit Sanofi's profile page to view all their available research.

ResearchPool Subscriptions

Get the most out of your insights

Get in touch