Sanofi explores combination treatments for multiple myeloma in new late-stage trials
08 December 2017 - 12:00AM
Business Wire
* Phase 3 trials will evaluate isatuximab, an anti-CD38
antibody, in combination with other cancer treatments
* Studies will focus on patients with relapsed and first-line
multiple myeloma
* Separate isatuximab data will be presented at upcoming
American Society of Hematology meeting
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 designationIsatuximab 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 meetingFindings 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:
1887Presenter: Dr. Paul Richardson
- “In Vivo Vaccination” Effect in
Clinical Responders to Anti-Myeloma Monoclonal Antibody
IsatuximabAbstract: 1830Presenter: 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 TransplantationAbstract: 3160Presenter: Dr.
Enrique M. Ocio
- Pre-Clinical Efficacy of the
Anti-CD38 Monoclonal Antibody (mAb) Isatuximab in Acute Myeloid
Leukemia (AML)Abstract: 2655Presenter: 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.
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