Sarclisa accepted for FDA priority review for the treatment of transplant-
ineligible newly diagnosed multiple myeloma
* FDA Priority Review granted based on positive results from IMROZ phase 3
study
* If approved, Sarclisa would be the first anti-CD38 therapy in combination
with standard-of-care treatment for patients with newly diagnosed
transplant-ineligible multiple myeloma
* Pivotal IMROZ phase 3 study results to be featured during oral presentation
at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Paris, May 27, 2024. The U.S. Food and Drug Administration (FDA) has accepted
for Priority Review the supplemental Biologics License Application (sBLA) for
the investigational use of Sarclisa (isatuximab) in combination with bortezomib,
lenalidomide and dexamethasone (VRd) for the treatment of patients with
transplant-ineligible newly diagnosed multiple myeloma (NDMM). If approved,
Sarclisa would be the first anti-CD38 therapy in combination with standard-of-
care VRd in newly diagnosed patients not eligible for transplant, which would be
the third indication for Sarclisa in multiple myeloma. The target action date
for the FDA decision is September 27, 2024. A regulatory submission is also
under review in the European Union (EU).
Dietmar Berger, M.D., Ph.D.
Chief Medical Officer, Global Head of Development at Sanofi
"Despite recent advancements in multiple myeloma treatment, there remains a
significant unmet need for new frontline therapies, particularly for transplant-
ineligible patients who can face poor outcomes from the disease. The filing
acceptances, as well as the FDA's Priority Review designation, reinforce our
confidence in Sarclisa as a potential best-in-class treatment and represent a
critical step toward advancing this combination in a difficult-to-treat cancer."
The sBLA, as well as the submission in the EU, is based on positive results from
the IMROZ phase 3 clinical study evaluating the investigational use of Sarclisa
in combination with standard-of-care VRd. In December 2023
(https://www.sanofi.com/en/media-room/press-releases/2023/2023-
12-07-06-35-00-2792221), the study met its primary endpoint at a planned interim
analysis for efficacy, demonstrating statistically significant improvement in
progression-free survival (PFS) with Sarclisa in combination with VRd compared
with VRd alone in transplant-ineligible patients with NDMM. The safety and
tolerability of Sarclisa observed in this study was consistent with the
established safety profile of Sarclisa and VRd.
The IMROZ study is the fourth phase 3 study investigating Sarclisa combinations
in NDMM patients to show superiority versus standard-of-care VRd and KRd,
reinforcing its best-in-class potential. Results from the IMROZ study will also
be featured during an oral presentation at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting and during the plenary scientific session at the
2024 European Hematology Association (EHA) Annual Congress.
Priority Review is granted to regulatory applications seeking approval for
therapies that have the potential to provide significant improvements in the
treatment, diagnosis or prevention of serious conditions.
The investigational use of Sarclisa in combination with VRd in patients with
transplant-ineligible NDMM is currently under clinical development, and its
safety and efficacy for this indication have not been fully evaluated by any
regulatory authority.
About the study
The global, randomized, multi-center, open-label IMROZ phase 3 clinical study
enrolled 446 patients with newly diagnosed, transplant-ineligible MM across 21
countries and 104 centers. During the study, 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 was progression-free survival. Key secondary endpoints
include complete response rate, minimal residual disease (MRD) negativity rate
for patients with a complete response, very good partial response or better
rate, and overall survival. Other secondary endpoints were 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)
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 activities. 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 certain 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 studies
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 studies, please visit
www.clinicaltrials.gov (http://www.clinicaltrials.gov).
About multiple myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy,(2) with
more than 180,000 new diagnoses of MM worldwide yearly.(3) Despite available
treatments, MM remains an incurable malignancy with an estimated 52% five-year
survival rate for newly diagnosed patients.(4) 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 Sanofi
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the miracles of science to improve people's lives. Our team, across the world,
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
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(1)
ClinicalTrials.gov.Identifier#NCT03319667. https://clinicaltrials.gov/ct2/show/N
CT03319667. Accessed March 2024.
(2) Kazandjian D. Multiple myeloma epidemiology and survival: A unique
malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004.
(3) World Health Organization. Multiple Myeloma. 35-multiple-myeloma-fact-
sheet.pdf (who.int).
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-
fact-sheet.pdf) Accessed March 2024.
(4) Fonseca, R., Usmani, S.Z., Mehra, M. et al. Frontline treatment patterns and
attrition rates by subsequent lines of therapy in patients with newly diagnosed
multiple myeloma. BMC Cancer. 2020: 20(1087). https://doi.org/10.1186/s12885-
020-07503-y
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