Sarclisa obtains first approval in China for the
treatment of adult patients with relapsed or refractory multiple
myeloma
- Approval based on positive pivotal
ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world
study as bridging data, which demonstrated Sarclisa and the
standard treatment Pd, improved responses and long-term outcomes
compared to Pd alone in R/R MM patients
- Sarclisa-Pd is currently
recommended by the Chinese Society of Clinical Oncology (CCSCO) and
Chinese Anti-Cancer Association (CACA) treatment guidelines for
this patient population
Paris, January 13, 2025. The
National Medical Products Administration (NMPA) in China has
approved Sarclisa, an anti-CD38 medicine, in combination with
pomalidomide and dexamethasone (Pd) for the treatment of adult
patients with multiple myeloma (MM) who have received at least one
prior line of therapy, including lenalidomide and a proteasome
inhibitor.
This approval is based on results from the
pivotal ICARIA-MM phase 3 study, using the China-based IsaFiRsT
real-world study as bridging data. The ICARIA-MM study demonstrated
Sarclisa in combination with Pd significantly reduced the risk of
disease progression or death by 40% (HR 0.596, 95% CI 0.44-0.81,
p=0.001), and resulted in a clinically meaningful, 6.9-month
improvement in overall survival (OS) (HR=0.78; log-rank 1-sided
P=0.0319), compared to Pd alone. Additionally, the IsaFiRsT study,
which is the first real-world study for the registration of an
anti-CD38 therapy in combination with Pd in China, showed an
overall response rate (ORR) of 82.6% among relapsed or refractory
multiple myeloma (R/R MM) adult patients.
Olivier NatafGlobal Head,
Oncology “This approval marks an important milestone for Sanofi in
China. The results of the ICARIA-MM phase 3 study, coupled with the
real-world IsaFiRsT study, highlight the benefit of Sarclisa for
patients living with multiple myeloma and the importance of
innovative regulatory pathways for timely access to different
treatments. We look forward to continuing to build strong
partnerships with the medical community, local companies, and
authorities in China as we work to bring more innovative treatments
to patients.”
Through the Lecheng Pilot for real-world data
application, the NMPA has increasingly used real-world evidence
(RWE) to help accelerate the review and approval of innovative
therapies and medical devices in China. Sarclisa was one of the
first three treatments authorized for real-world studies as part of
the pilot program and is the first blood cancer treatment approved
based on RWE, in addition to clinical data.
In addition to the NMPA approval, the Chinese
Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer
Association (CACA) guidelines include Sarclisa-Pd as a "Category I
Recommendation" and the "Preferred Option" for the treatment of
patients with first-relapsed MM. Beyond R/R MM, a regulatory
submission for Sarclisa in combination with bortezomib,
lenalidomide and dexamethasone (VRd) for newly diagnosed multiple
myeloma (NDMM) in adult patients not eligible for autologous stem
cell transplant, is also under review in China with a final
decision expected in the coming months.
As one of the first multinational companies to
enter China in 1982, Sanofi is committed to accelerating the
introduction of innovative medicines and vaccines into China,
aiming to transform the practice of medicine for the benefit of
more Chinese people.
About the ICARIA-MM studyICARIA-MM was a pivotal
phase 3 randomized, open-label, multi-center trial evaluating
Sarclisa in combination with Pd versus Pd alone in patients with
R/R MM. The study enrolled 307 patients with R/R MM across 96
centers spanning 24 countries. Overall, patients had received a
median of three prior lines of anti-myeloma therapies, including at
least two consecutive cycles of lenalidomide and a proteasome
inhibitor given alone or in combination.
During the trial, Sarclisa was administered by
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 Pd for the duration of treatment. The primary
endpoint of ICARIA-MM was progression-free survival (PFS). Key
secondary endpoints included ORR and OS.
About the IsaFiRsT studyThe IsaFiRsT study was a
single-arm, observational, prospective, real-world study evaluating
Sarclisa in combination with Pd in patients with R/R MM. The study
enrolled 24 patients with R/R MM at one site in China. Overall,
patients received a median of three prior lines of therapy,
including lenalidomide and a proteasome inhibitor, and had
measurable serum or urine M-protein.
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 standard doses of Pd for the duration of
treatment. Treatment continued until disease progression or
unacceptable toxicity. The primary endpoint of IsaFiRsT was ORR.
Key secondary endpoints included PFS, OS, duration of response
(DOR) and safety.
About SarclisaSarclisa (isatuximab) is a CD38
monoclonal antibody that binds to a specific epitope on the CD38
receptor on 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 target for antibody-based therapeutics such
as Sarclisa. In the US, the non-proprietary 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 US FDA.
Currently, Sarclisa is approved in more than 50
countries, including the US and EU, across two indications;
Sarclisa is approved under an additional indication in the US.
Based on the ICARIA-MM phase 3 study, Sarclisa is approved in
combination with Pd for the treatment of patients with R/R MM who
have received ≥2 prior therapies, including lenalidomide and a
proteasome inhibitor, and who progressed on last therapy. Based on
the IKEMA phase 3 study, Sarclisa is also approved in 50 countries
in combination with carfilzomib and dexamethasone, including in the
US for the treatment of patients with R/R MM who have received 1–3
prior lines of therapy and in the EU for patients with MM who have
received at least 1 prior therapy. In the US, Sarclisa is approved
in combination with VRd as a front-line treatment option for adult
patients with NDMM not eligible for transplant based on the IMROZ
phase 3 study. On November 14, 2024, the European Medicines Agency
(EMA)’s Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion recommending the approval of
Sarclisa-VRd in this patient population. A final decision is
expected in the coming months.
Sanofi continues to advance Sarclisa as part of
a patient-centric clinical development program, which includes
several phase 2 and phase 3 studies across the MM treatment
continuum spanning six potential indications. In addition, the
company is evaluating a subcutaneous administration method for
Sarclisa in clinical studies. The safety and efficacy of Sarclisa
has not been evaluated by any regulatory authority outside of its
approved indications and methods of delivery.
In striving to become the number one
immunoscience company globally, Sanofi remains committed to
advancing oncology innovation. Through focused strategic decisions
the company has reshaped and prioritized its pipeline, leveraging
its expertise in immunoscience to drive progress. Efforts are
centered on difficult-to-treat often rare cancers such as select
hematologic malignancies and solid tumors with critical unmet
needs, including multiple myeloma, acute myeloid leukemia, certain
types of lymphomas, as well as gastrointestinal and lung
cancers.
For more information on Sarclisa clinical
studies, please visit www.clinicaltrials.gov.
About Sanofi We are an innovative global healthcare
company, driven by one purpose: we chase 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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