Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of
progression free survival in patients with newly diagnosed multiple
myeloma not eligible for transplant
- Sarclisa added to
bortezomib, lenalidomide and dexamethasone (VRd) significantly
reduced the risk of disease progression or death compared with VRd
alone
- First global Phase 3
study to report positive results with an anti-CD38 therapy in
combination with VRd in transplant-ineligible patients, reinforcing
the potential for Sarclisa as a best-in-class medicine
- Study results will be
submitted for presentation at an upcoming medical meeting and form
the basis of a future regulatory submission
PARIS, December 7, 2023. The
Phase 3 IMROZ trial evaluating the investigational use of Sarclisa®
(isatuximab) in combination with standard-of-care bortezomib,
lenalidomide and dexamethasone (VRd) met its primary endpoint at a
planned interim analysis for efficacy, demonstrating statistically
significant improvement in progression-free survival (PFS) compared
with VRd alone in transplant-ineligible patients with newly
diagnosed multiple myeloma (MM). This is also the second Phase 3
trial investigating Sarclisa in newly diagnosed patients to show
superiority versus standard of care.
Thierry
Facon, MDProfessor of Haematology in the Department of
Haematology, Lille University Hospital, Lille, France, member of
French Academy of Medecine and IMROZ Principal Investigator
“The IMROZ trial outcome is promising for
patients with newly diagnosed multiple myeloma who are
transplant-ineligible, as there remains a significant unmet need
for potential new therapies. First line therapeutic options are
critical for all patients, but especially for those who are
transplant-ineligible, given attrition rates in subsequent lines of
therapy.”
The safety and tolerability of Sarclisa observed
in this trial was consistent with the established safety profile of
Sarclisa and VRd.
Dietmar Berger, MD, PhD Global
Head of Development, Sanofi
"This is the second Phase 3 trial investigating
Sarclisa in newly diagnosed patients to show superiority versus
standard of care, reinforcing our belief in Sarclisa as a
best-in-class medicine. These data underscore our commitment to
advancing scientific innovation for people living with multiple
myeloma, and we look forward to sharing more detail on Sarclisa’s
potential to improve outcomes for patients receiving earlier lines
of therapy.”
Study results will be submitted for presentation
at an upcoming medical meeting and form the basis of a future
regulatory submission.
About the IMROZ trial
The randomized, multi-center, open label Phase 3
IMROZ clinical trial enrolled 484 patients with newly diagnosed
transplant-ineligible MM across 104 centers spanning 21 countries.
During the trial, Sarclisa was administered through an intravenous
infusion at a dose of 10 mg/kg once weekly for five weeks during
first 42-day cycle and once every two weeks in cycles 2 to 4 in
combination with subcutaneous bortezomib, oral lenalidomide and
intravenous or oral dexamethasone. Then Sarclisa was administered
every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+
during 28-day cycles in combination with lenalidomide and
dexamethasone at the standard dose, until disease progression,
unacceptable safety profile or patient’s decision to stop the study
treatment. The primary endpoint of IMROZ is progression-free
survival. Key secondary endpoints include complete response rate,
minimal residual disease negativity rate for patients with a
complete response, very good partial response or better rate,
overall survival. Other secondary endpoints are: overall response
rate, time to progression, duration of response, time to first
response, time to best response, progression-free survival on next
line of therapy, progression-free survival by MRD status, sustained
MRD negativity greater than or equal to 12 months rate, safety,
pharmacokinetic profile, immunogenicity, disease-specific and
generic health-related quality of life, disease and
treatment-related symptoms, health state utility, and health
status.1
The use of Sarclisa in combination with VRd in
transplant-ineligible newly diagnosed MM 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 (MM)
cells, inducing distinct antitumor activity. It is designed to work
through multiple mechanisms of action including programmed tumor
cell death (apoptosis) and immunomodulatory activity. CD38 is
highly and uniformly expressed on the surface of MM cells, making
it a potential target for antibody-based therapeutics such as
Sarclisa.
Based on the Phase 3 ICARIA-MM study, Sarclisa
is approved in >50 countries, including the U.S. and EU, in
combination with pomalidomide and dexamethasone for the treatment
of patients with relapsed refractory MM (RRMM) who have received ≥2
prior therapies, including lenalidomide and a proteasome inhibitor
and who progressed on last therapy. Based on the Phase 3 IKEMA
study, Sarclisa is also approved in 50 countries in combination
with carfilzomib and dexamethasone, including in the U.S. for the
treatment of patients with RRMM who have received 1–3 prior lines
of therapy and in the European Union for patients with MM who have
received at least 1 prior therapy. 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 (FDA).
Sarclisa continues to be evaluated in multiple
ongoing Phase 3 clinical trials in combination with current
standard treatments across the MM treatment continuum. It is also
under investigation for the treatment of other hematologic
malignancies, and its safety and efficacy have not been evaluated
by any regulatory authority outside of its approved indication.
For more information on Sarclisa clinical
trials, please visit www.clinicaltrials.gov.
About multiple myeloma
MM is the second most common hematologic
malignancy.2 Since MM does not have a cure, most patients will
relapse. Relapsed MM is the term for when the cancer returns after
treatment or a period of remission. Refractory MM refers to when
the cancer does not respond or no longer responds to
therapy.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Media RelationsSally
Bain | + 1 781 264-1091
| sally.bain@sanofi.comVictor Rouault
| + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39 |
eva.schaefer-jansen@sanofi.comArnaud Delépine | +
33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 06 40 56 92 |
corentine.driancourt@sanofi.comFelix Lauscher | +
1 908 612 7239 | felix.lauscher@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comNathalie Pham | + 33 07
85 93 30 17 | nathalie.pham@sanofi.com
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1ClinicalTrials.gov.Identifier#NCT03319667.
https://clinicaltrials.gov/ct2/show/NCT03319667. Accessed September
2023.2 Kazandjian. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004.
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