Sarclisa induction treatment demonstrated
significantly improved progression-free survival in patients with
newly diagnosed multiple myeloma eligible for transplant
- Sarclisa (isatuximab) in combination
with standard-of-care lenalidomide, bortezomib, and dexamethasone
(RVd) during 18-week induction treatment followed by transplant
resulted in a statistically significant and clinically meaningful
improvement in progression-free survival compared to RVd induction
therapy, regardless of maintenance therapy assignment, in the
investigational use for transplant-eligible newly diagnosed
multiple myeloma (NDMM)
- GMMG-HD7 is one of six phase 3 studies
to report positive results for Sarclisa in multiple myeloma (MM),
which includes four positive readouts of a Sarclisa-based
quadruplet in the frontline setting
- Results reinforce the potential of
Sarclisa as a backbone therapy when added to the current
standard-of-care in various MM patient populations
Paris, August 8, 2024. New
results from the two-part, double-randomized, German-speaking
Myeloma Multicenter Group (GMMG)-HD7 phase 3 study show that
Sarclisa (isatuximab) in combination with lenalidomide, bortezomib,
and dexamethasone (RVd) during induction therapy in
transplant-eligible, newly diagnosed multiple myeloma (NDMM)
significantly prolonged progression-free survival (PFS) from first
randomization, resulting in a statistically significant and
clinically meaningful reduction in disease progression or death,
compared to RVd induction regardless of the maintenance regimen.
Full results will be submitted for presentation at a forthcoming
medical meeting.
Hartmut Goldschmidt,
MDPresident of GMMG, Professor of Medicine at the
Heidelberg University Hospital (UKHD), Germany and principal
investigator of the study“Successful induction therapy is one of
the most critical components to reduce the relapse or recurrence
risk in patients with newly diagnosed multiple myeloma. While we
observed this investigational combination showed improved minimal
residual disease negativity rates in the bone marrow, indicating
potentially deeper responses after induction, further follow-up was
needed to better understand how this translated to long-term
outcomes. These data provide evidence that the Isa-RVd regimen
potentially improves progression-free survival in the frontline,
transplant-eligible population and supports the potential of this
quadruplet to become a new standard-of-care induction regimen in
this treatment setting.”
GMMG-HD7 is one of six phase 3 studies to report
positive results for Sarclisa in patients with multiple myeloma,
which includes four positive readouts of a Sarclisa-based
quadruplet in the frontline setting. The most recent included
results from the IMROZ phase 3 study evaluating the investigational
use of Sarclisa with VRd versus VRd for patients with
transplant-ineligible NDMM, demonstrating a statistically
significant and clinically meaningful improvement in PFS and a
higher proportion of patients with minimal residual disease (MRD)
negativity.
Dietmar Berger, MD, PhD Chief
Medical Officer and Global Head of Development at Sanofi“The
GMMG-HD7 study was designed to better understand the distinct
effect of targeting CD38 with Sarclisa in induction versus
maintenance treatment of transplant-eligible patients. These data
build upon our belief that Sarclisa has the potential to be a
best-in-class CD38 therapy that could improve long-term outcomes
versus the standard-of-care for certain patients. We look forward
to the full data presentation and continuing our mission of helping
make a meaningful difference for people living with multiple
myeloma.”
In December 2021, Sanofi and GMMG shared the
results from part one, which met the primary endpoint of MRD
negativity after induction therapy and before transplant in NDMM
patients. The GMMG-initiated study is being conducted in close
collaboration with Sanofi based on jointly defined research. Sanofi
provided financial support to GMMG for this study. The use of
Sarclisa in combination with RVd is investigational and has not
been evaluated by any regulatory authority.
While considered a rare disease, MM is the
second most common hematologic malignancy,1 with more than 180,000
new diagnoses of MM worldwide yearly.2 Despite available
treatments, MM remains an incurable malignancy in most patients
with an estimated 61% five-year survival rate for newly diagnosed
patients.3 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 the GMMG-HD7 studyGMMG-HD7 is a pivotal
randomized, open-label, multicenter, 2-part phase 3 study
evaluating Sarclisa in combination with RVd versus RVd induction
followed by post-transplant re-randomization to Sarclisa plus
lenalidomide versus lenalidomide maintenance in transplant-eligible
NDMM patients. The study enrolled 662 patients with
transplant-eligible NDMM across 67 sites in Germany. In the first
part of the study, all participants were equally randomized to
receive three 42-day cycles of RVd in both arms of the study, while
Sarclisa was added to only one study arm. In the second part of the
study, patients were re-randomized post-transplant to receive
Sarclisa plus lenalidomide or lenalidomide alone as maintenance
therapy. During the study, Sarclisa was administered through an
intravenous infusion at a dose of 10 mg/kg once weekly for the
first four weeks of cycle one, then every other week for the rest
of the induction period.
MRD negativity was assessed by next-generation
flow cytometry (sensitivity of 1x10-5) after induction. In the
latest readout of the study, PFS for both Sarclisa plus RVd as an
induction therapy, regardless of maintenance treatment, and
Sarclisa plus lenalidomide as a maintenance regimen were measured
from first randomization.
GMMG-HD7 protocol defined the primary endpoints
of MRD negativity after induction treatment for the first part of
the study, and PFS following the second randomization after
transplant for part two of the study, in which Sarclisa was added
to lenalidomide maintenance, with the latter primary endpoint
anticipated to be available at a later date. The key secondary
endpoint for the first part of the study was PFS from first
randomization. Additional secondary endpoints included rates of
complete response after induction, and intensification, overall
survival, and safety.
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, and explore potential new
combinations including assessing 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, there is a commitment to advancing
oncology innovation. The pipeline is being reshaped and
prioritized, leveraging expertise in immunoscience to drive
progress. Efforts are centered on 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 the German-speaking Myeloma Multicenter
Group (GMMG)GMMG is the largest study group focusing on MM in
Germany, with headquarters based in Heidelberg. Within the last 20+
years, the GMMG study group has performed numerous studies
including five randomized, multicenter phase 3 studies with 4,000
patients enrolled from about 90 participating and co-treating
centers throughout Germany. The overall goal of GMMG is to generate
improved therapies for myeloma patients through the development and
testing of novel and personalized, genome- and signaling-driven
treatment strategies. The GMMG has set itself the goal of achieving
further approvals for effective antibody-based drug combinations
for the first-line treatment of myeloma patients, in which
antibody-based treatment regimens have been integrated into seven
GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and
HD10).
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
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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 World Health Organization.
Multiple Myeloma. 35-multiple-myeloma-fact-sheet.pdf (who.int).
Accessed March 2024.3 National Cancer Institute. Surveillance,
Epidemiology, and End Results Program (SEER). Cancer Stat Facts:
Myeloma. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed August
2024.
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