Sanofi : Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/r...
05 Febrero 2019 - 12:02AM
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 ContactAshleigh Koss Tel.: +1
908-981-8745Ashleigh.Koss@sanofi.com |
Investor Relations
ContactGeorge Grofik Tel.: +33 (0)1 53 77 45
45ir@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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