New Sarclisa subcutaneous formulation met
co-primary endpoints in the IRAKLIA phase 3 study in multiple
myeloma
- Sarclisa SC formulation added to Pd
for the treatment of R/R MM met the co-primary endpoints in the
IRAKLIA phase 3 study, demonstrating non-inferiority compared to
Sarclisa IV
- IRAKLIA is the first global phase 3
study to evaluate the SC administration of a cancer treatment via
an OBDS
- OBDS is an alternative delivery
method designed to improve the patient experience and currently
available SC administration
Paris, January 9, 2025. Results
from the investigational, randomized, open-label IRAKLIA phase 3
study demonstrated that Sarclisa administered at a fixed dose
subcutaneously (SC) via an on-body delivery system (OBDS) in
combination with pomalidomide and dexamethasone (Pd) met its
co-primary endpoints of non-inferior objective response rate (ORR)
and observed concentration before dosing (C trough) at steady state
compared to intravenous (IV) Sarclisa administered at a
weight-based dose in combination with Pd in patients with relapsed
or refractory multiple myeloma (R/R MM). Key secondary endpoints,
including very good partial response (VGPR), incidence rate of
infusion reactions and C trough at cycle 2 were also achieved. The
study is ongoing, and the full results will be presented at a
forthcoming medical meeting.
Sikander Ailawadhi, MDProfessor
of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida
and principal investigator of the study“The consistent overall
response rate and comparable efficacy and safety profile observed
in the IRAKLIA study for subcutaneous Sarclisa represent an
exciting advancement, offering insight into a potential new
administration option for patients. The results from IRAKLIA, in
patients with relapsed or refractory multiple myeloma, support the
potential of an on-body delivery system to help ease the delivery
of a new formulation without impacting patient outcomes.”
The IRAKLIA study was conducted using Enable
Injections’ enFuse® hands-free OBDS, which was designed to
administer high-volume medicines subcutaneously through an
automated drug delivery technology. The enFuse device leverages a
hidden and retractable needle that is thinner compared to commonly
used SC injection needles.
Houman Ashrafian, MD, PhD
Executive Vice President, Head of Research and Development at
Sanofi “We are fueled by our focus on innovation and finding
best-in-class solutions to help ease the burden of disease for
patients. The IRAKLIA study results are a prime example of what’s
driving our scientific engine. Being able to possibly bring a novel
option that helps reduce time in a healthcare facility is driven by
our patient and provider-centric mindset. We look forward to
sharing full results and working to bring this new advancement to
the multiple myeloma community.”
Additional studies evaluating Sarclisa SC
formulations across different combinations and lines of therapy are
ongoing. The safety and efficacy of Sarclisa SC and the enFuse
device have not been evaluated by any regulatory authority outside
of their approved indications. Regulatory submissions in the US and
in the EU are planned during the first half of 2025.
About the IRAKLIA studyIRAKLIA is a randomized,
open-label, pivotal phase 3 study evaluating the non-inferiority of
Sarclisa SC formulation administered at a fixed dose subcutaneously
via an OBDS versus weight-based dosed Sarclisa IV in combination
with Pd in adult patients with R/R MM. The study enrolled 531
patients across 252 global sites, who were equally randomized to
receive Sarclisa SC or IV in combination with Pd for 28-day cycles
until disease progression, unacceptable adverse events (AEs),
participant request to discontinue therapy or any other reason,
whichever came first. In the SC arm, Sarclisa was administered at a
fixed dose SC weekly for four weeks during the first cycle and
every two weeks for subsequent cycles. In the IV arm, Sarclisa was
administered at a weight-based dose via IV infusion weekly for four
weeks during the first cycle and every two weeks for subsequent
cycles. The study enrolled adult patients with MM who have received
at least one prior line of therapy, including lenalidomide and a
proteasome inhibitor.
The co-primary outcomes being assessed are ORR,
defined as the proportion of patients with stringent complete
response, complete response, VGPR, and partial response (PR)
according to the 2016 IMWG criteria assessed by Independent Review
Committee (IRC), and observed C trough at steady state, defined as
observed Sarclisa plasma concentrations.
About Enable InjectionsBased in the US (Cincinnati,
Ohio), Enable Injections is a global healthcare innovation company
committed to improving the patient treatment experience through the
development and manufacturing of enFuse. enFuse is an innovative
wearable drug delivery platform that is designed to deliver large
volumes of pharmaceutical and biologic therapeutics via
subcutaneous administration, with the aim of improving convenience,
supporting superior outcomes, and advancing healthcare system
economics. For more information, visit
https://enableinjections.com.
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 bortezomib, lenalidomide, and dexamethasone
(VRd) as a front-line treatment option for adult patients with
newly diagnosed multiple myeloma (NDMM) who are not eligible for
autologous stem cell transplant (ASCT), 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. Further clinical
studies evaluating a subcutaneous administration method for
Sarclisa are ongoing.
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
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comEvan Berland |
+1 215 432 0234 | evan.berland@sanofi.com Nicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.com Léo Le Bourhis | + 33 6
75 06 43 81 | leo.lebourhis@sanofi.com Victor
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.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.com Keita
Browne | + 1 781 249 1766 |
keita.browne@sanofi.com Nathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com Tarik Elgoutni | + 1 617
710 3587 | tarik.elgoutni@sanofi.com Thibaud
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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