Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma
May 12 2020 - 1:00AM
Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary
endpoint early in patients with relapsed multiple
myeloma
- IKEMA trial results released early based on recommendation of
an Independent Data Monitoring Committee
- Addition of Sarclisa significantly reduced the risk of disease
progression or death compared to carfilzomib and dexamethasone
alone
- Results will be submitted to an upcoming medical meeting and
form the basis for regulatory submissions later this year
PARIS – May 12, 2020 - The
Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab)
added to carfilzomib and dexamethasone met the primary endpoint at
its first planned interim analysis, demonstrating significantly
prolonged progression-free survival compared to standard of care
carfilzomib and dexamethasone alone in patients with relapsed
multiple myeloma. There were no new safety signals identified in
this study.
“When Sarclisa was added to standard-of-care
treatment carfilzomib and dexamethasone in this phase 3 trial,
results clearly demonstrated a significant reduction in risk of
disease progression or death,” said John Reed, M.D., Ph.D., Global
Head of Research and Development at Sanofi. “This is the second
positive phase 3 trial for Sarclisa, further supporting the
potential our medicine has to improve outcomes for patients
struggling with relapsed multiple myeloma.”
Results will be submitted to an upcoming medical
meeting and are anticipated to form the basis of regulatory
submissions planned for later this year.
About the Trial
The randomized, multi-center, open label Phase 3
IKEMA clinical trial enrolled 302 patients with relapsed multiple
myeloma across 69 centers spanning 16 countries. All study
participants received one to three prior anti-myeloma therapies.
During the trial, Sarclisa 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 carfilzomib
twice weekly at the 20/56mg/m2 dose and dexamethasone at the
standard dose for the duration of treatment. The primary endpoint
of IKEMA is progression-free survival. Secondary endpoints include
overall response rate, the rate of very good partial response or
greater, minimal residual disease, complete response rate, overall
survival and safety.
The use of Sarclisa in combination
with carfilzomib and dexamethasone in relapsed multiple
myeloma is investigational and has not been fully evaluated by any
regulatory authority.
About Sarclisa
Sarclisa is a monoclonal antibody that binds to
a specific epitope on the CD38 receptor on multiple myeloma cells.
It is designed to work through many mechanisms of action including
programmed tumor cell death (apoptosis) and immunomodulatory
activity. CD38 is highly and uniformly expressed on the surface of
multiple myeloma cells, making it a potential target for
antibody-based therapeutics such as Sarclisa.
Sarclisa is approved in the U.S. in combination
with pomalidomide and dexamethasone for the treatment of adults
with relapsed refractory multiple myeloma who have received at
least two prior therapies including lenalidomide and a proteasome
inhibitor. In the U.S., the generic name for Sarclisa is
isatuximab-irfc, with irfc as the suffix designated in accordance
with Nonproprietary Naming of Biological Products Guidance for
Industry issued by the U.S. Food and Drug Administration.
Sarclisa has also received positive CHMP opinion
in combination with pomalidomide and dexamethasone for the
treatment of adults with relapsed and refractory multiple myeloma
who have received at least two prior therapies including
lenalidomide and a proteasome inhibitor and have demonstrated
disease progression on the last therapy. A final decision on the
Marketing Authorisation Application for Sarclisa in the E.U. is
expected in the coming months. The safety and efficacy of Sarclisa
has not been fully evaluated by any regulatory authority outside of
the U.S., Switzerland, Canada and Australia.
Sarclisa continues to be evaluated in multiple
ongoing Phase 3 clinical trials in combination with current
standard treatments for people with multiple myeloma. It is also
under investigation for the treatment of other blood cancer types
(hematologic malignancies) and solid tumors.
For more information on Sarclisa clinical trials
please visit www.clinicaltrials.gov.
About Multiple Myeloma
Multiple myeloma is the second most common
hematologic malignancy, with more than 138,000 new diagnoses of
multiple myeloma worldwide yearly. Despite available treatments,
multiple myeloma remains an incurable malignancy, and is associated
with significant patient burden. Since multiple myeloma does not
have a cure, most patients will relapse. Relapsed multiple myeloma
is the term for when the cancer returns after treatment or a period
of remission. Refractory multiple myeloma refers to when the cancer
does not respond or no longer responds to therapy.
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the globe. Sanofi, Empowering Life |
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(908) 981-8745 Ashleigh.Koss@sanofi.com |
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