Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma

* Study evaluated the benefit of isatuximab in combination with standard of care
in prolonging progression free survival as compared to standard of care in
patients with relapsed/refractory multiple myeloma
* First randomized Phase 3 trial to evaluate the benefit of adding a monoclonal
antibody to pomalidomide and dexamethasone for treatment of
relapsed/refractory multiple myeloma
* Multiple ongoing Phase 3 studies with isatuximab, an investigational agent, in
combination with standard of care therapies in newly diagnosed and
relapsed/refractory multiple myeloma
PARIS – February 5, 2019 – The pivotal Phase 3 trial of isatuximab in patients with
relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression
free survival in patients treated with isatuximab in combination with pomalidomide and lowdose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard
of care).
Results will be submitted to an upcoming medical meeting and are anticipated to form the
basis of regulatory submissions planned for later this year.
“We are excited by these results, which represent significant progress in our
ambition to extend the lives of multiple myeloma patients,” said John Reed, Head
of Research and Development at Sanofi. “We look forward to engaging with
regulatory authorities with the goal of bringing this potential new treatment to
patients as quickly as possible.”
Multiple myeloma is the second most common hematologic malignancy1, with more than
138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast
majority of patients, resulting in significant disease burden.
The randomized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled
307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24
countries. All study participants received two or more prior anti-myeloma therapies,
including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given
alone or in combination. During the trial, isatuximab was administered through an
intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other
week for 28-day cycles in combination with standard doses of pomalidomide and
dexamethasone for the duration of treatment. The safety profile was evaluated as a
secondary endpoint.
About isatuximab clinical development program
Isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct
mechanisms of action that are believed to promote programmed tumor cell death
(apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on
multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics
in multiple myeloma and other malignancies. The clinical significance of these findings is
under investigation.
ICARIA-MM is one of four ongoing Phase 3 clinical trials evaluating isatuximab in
combination with currently available standard treatments for people with
relapsed/refractory or newly-diagnosed multiple myeloma.
Isatuximab received orphan designation for relapsed/refractory multiple myeloma by the
U.S. Food and Drug Administration and the European Medicines Agency. Isatuximab is an
investigational agent and the safety and efficacy has not been evaluated by the U.S. Food
and Drug Administration, the European Medicines Agency, or any other regulatory
authority. Isatuximab is also under investigation for the treatment of other hematologic
malignancies and solid tumors
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
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“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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at

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