Sarclisa approved in the US as the first
anti-CD38 therapy in combination with standard-of-care treatment
for adult patients with newly diagnosed multiple myeloma not
eligible for
transplant
- Approval based on positive results
from the IMROZ phase 3 study demonstrating Sarclisa in combination
with bortezomib, lenalidomide, and dexamethasone (VRd)
significantly improved progression-free survival (PFS), compared to
standard-of-care in newly diagnosed adult patients not eligible for
autologous stem cell transplant (ASCT)
- Third indication for Sarclisa,
evaluated under FDA Priority Review, underscores Sanofi’s
commitment to helping close a critical care gap in multiple myeloma
(MM)
PARIS, September 21, 2024. The
US Food and Drug Administration (FDA) has approved Sarclisa
(isatuximab) in combination with bortezomib, lenalidomide, and
dexamethasone (VRd) as a first line treatment option for adult
patients with newly diagnosed multiple myeloma (NDMM) who are not
eligible for autologous stem cell transplant (ASCT). Sarclisa is
the first anti-CD38 therapy in combination with standard-of-care
VRd to significantly reduce disease progression or death (by 40%)
compared to VRd alone for patients with NDMM not eligible for
transplant.
Thomas Martin M.D.Helen Diller
Family Comprehensive Cancer Center Clinical Professor of Medicine
at the University of California San Francisco“Multiple myeloma is
most frequently diagnosed in patients 65 years and older, yet the
options for treatment in this population are limited due to a
combination of age, frailty, and co-morbidities. This has resulted
in a longstanding need for new treatment options that can
potentially improve the standard-of-care. The significant clinical
benefit and improvements in progression-free survival demonstrated
by the IMROZ regimen of isatuximab plus VRd versus VRd alone make
today’s approval an important moment for this vulnerable patient
population and the larger multiple myeloma community.”
This decision marks the third approved
indication for Sarclisa in the US and the first approved indication
in newly diagnosed patients. The FDA evaluated Sarclisa for this
indication under Priority Review, which is reserved for medicines
that represent potentially significant improvements in efficacy or
safety in treating serious conditions. Sarclisa is also currently
approved in more than 50 countries across two indications for the
treatment of people with relapsed or refractory disease.
Brian FoardExecutive Vice
President, Head of Specialty Care, Sanofi“Since first launching in
2020, we have made significant progress towards our ambition of
establishing Sarclisa as a best-in-class therapy. The FDA’s
decision marks another momentous milestone toward our goal and
expands the reach of this potentially transformative therapy to a
larger population. With today’s approval, doctors now have an
important new option at their disposal that’s been shown to slow
disease progression for longer compared to the current
standard-of-care for adults living with newly diagnosed multiple
myeloma who are not eligible for transplant in the US.”
Results from the IMROZ phase 3 study supporting
Sarclisa in NDMM not eligible for ASCT
The FDA approval is based on data from the IMROZ
phase 3 study recently presented at the American Society of
Clinical Oncology (ASCO) 2024 annual meeting and published in The
New England Journal of Medicine. IMROZ is the first global phase 3
study of an anti-CD38 monoclonal antibody in combination with
standard-of-care VRd to significantly improve PFS versus VRd
alone.
In the IMROZ study, Sarclisa-VRd followed by
Sarclisa-Rd met the primary endpoint of PFS, significantly reducing
the risk of recurrence or death by 40%, compared to VRd followed by
Rd, in patients with NDMM not eligible for ASCT (HR 0.60; 95% CI:
0.44 to 0.81, p=0.0009). At a median follow-up of 59.7 months, the
median PFS with the Sarclisa-VRd combination was not reached versus
54.3 months with VRd. The estimated PFS-rate at 60 months was
63.2% for patients treated with Sarclisa-VRd versus 45.2% for
VRd.
Sarclisa-VRd also met several secondary
endpoints which demonstrated deep responses in this patient
population:
- Approximately three-quarters
(74.7%) of patients treated with Sarclisa-VRd achieved a complete
response (CR) or better compared to 64.1% of patients taking VRd
(OR 1.7; 95% CI: 1.097-2.5; p=0.0160).
- More than half (55.5%) of patients
treated with Sarclisa-VRd achieved MRD negative CR compared to
40.9% of patients taking VRd (OR 1.8; 95% CI: 1.229-2.646;
p=0.0026).
The safety and tolerability of Sarclisa observed
in this study was consistent with the established safety profile of
Sarclisa and VRd with no new safety signals observed. The most
common adverse reactions (≥20%) were upper respiratory tract
infections, diarrhea, fatigue, peripheral sensory neuropathy,
pneumonia, musculoskeletal pain, cataract, constipation, peripheral
edema, rash, infusion-related reaction, insomnia, and COVID-19. The
most common hematologic laboratory abnormalities (≥80%) were
decreased hemoglobin, decreased leukocytes, decreased lymphocytes,
decreased platelets, and decreased neutrophils. Serious adverse
reactions occurred in 71% of patients receiving Sarclisa
combination therapy. The most frequent serious adverse reaction
occurring in more than 5% of patients was pneumonia (30%).
Permanent discontinuation of treatment due to an adverse reaction
occurred in 22.8% of patients treated with Sarclisa combination
therapy, compared to 26% in the comparator arm.
Advancing Sarclisa in multiple myeloma
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 September, isatuximab-irfc (Sarclisa) was
also added to the National Comprehensive Cancer Network (NCCN®)
Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for MM
non-transplant candidates as an NCCN Category 1 Preferred option in
combination with VRd for patients <80 years old who are not
frail. Category 1 is based upon high-level evidence, there is
uniform NCCN consensus that the intervention is appropriate.
Preferred intervention are interventions that are based on superior
efficacy, safety, and evidence; and, when appropriate,
affordability.
*NCCN makes no warranties of any kind whatsoever
regarding their content, use or application and disclaims any
responsibility for their application or use in any way.
About SarclisaSarclisa (isatuximab) is a
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.
Based on the ICARIA-MM phase 3 study, Sarclisa
is approved in more than 50 countries, including the US and the 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 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 RRMM who have received 1–3
prior lines of therapy and in the EU for patients with MM who have
received at least one prior therapy. 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 Food and Drug
Administration.
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.
Sanofi is committed to pursuing the advancement
of Sarclisa through several investigational studies across the MM
treatment continuum. Various patient-centric clinical development
programs aim to bring Sarclisa to more patients, intercept the
disease earlier in the treatment journey, explore potential new
combinations and assess subcutaneous administration via a
proprietary on body device system. 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 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 multiple myelomaMM is the second most
common hematologic malignancy1, affecting more than 130,000
patients in the US; approximately 32,000 Americans are diagnosed
with MM each year.2 Despite available treatments, MM remains an
incurable malignancy with an estimated 52% five-year survival rate
for newly diagnosed patients.3 According to physician-based
surveys, the majority of NDMM patients are not considered eligible
for transplant, creating a need for new frontline therapeutic
options, particularly due to high attrition rates in subsequent
lines of 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 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
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comEvan Berland |
+1 215 432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.comAlizé
Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comKeita
Browne | + 1 781 249 1766 |
keita.browne@sanofi.comNathalie Pham | +
33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
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StatementsThis press release contains forward-looking
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Regarding Forward-Looking Statements” in Sanofi’s annual report on
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are the property of the Sanofi group.
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 National Cancer Institute.
Myeloma Cancer Stat Facts. Available at:
www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on December
12, 2019.3 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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