Sanofi : Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/r...
05 Febrero 2019 - 12:00AM
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 low-dose 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 malignancy[1], 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.
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, Empowering Life
|
Media Relations Contact Ashleigh
Koss
Tel.: +1 908-981-8745
Ashleigh.Koss@sanofi.com
|
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
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[1] Kazandjian.
Multiple myeloma epidemiology and survival: A unique malignancy.
Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004
[2] Cowan
AJ, Allen C, Barac A, et al. Global Burden of Multiple Myeloma: A
Systematic Analysis for the Global Burden of Disease Study 2016.
JAMA Oncol. 2018;4(9):1221-1227.
doi:10.1001/jamaoncol.2018.2128
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