Press Release: Sarclisa® (isatuximab) plus KRd significantly
improved rate of minimal residual disease negativity in
transplant-eligible patients with newly diagnosed multiple myeloma
versus KRd alone
Sarclisa® (isatuximab) plus KRd significantly
improved rate of minimal residual disease negativity in
transplant-eligible patients with newly diagnosed multiple myeloma
versus KRd alone
- Phase 3 data showed Sarclisa added to
carfilzomib, lenalidomide and dexamethasone (KRd) in patients with
newly diagnosed, transplant-eligible multiple myeloma resulted in
77% of patients achieving minimal residual disease (MRD) negativity
after consolidation therapy, detected with a sensitivity of
10-5
- MRD negativity rate measured at a
sensitivity of 10-6 was 67% for Sarclisa combination therapy
- Results shared during oral
presentation at ASH 2023 plenary scientific session
PARIS, December 10, 2023. The
Phase 3 trial investigating Sarclisa® (isatuximab) in combination
with carfilzomib, lenalidomide and dexamethasone (KRd) showed a
statistically significant improvement in the rate of minimal
residual disease (MRD) negativity, compared with KRd alone, after
autologous stem cell transplant (ASCT) consolidation in
transplant-eligible patients with newly diagnosed multiple myeloma
(MM). These results from the IsKia trial conducted by the European
Myeloma Network (EMN) were presented during the oral plenary
session (#4) at the American Society of Hematology (ASH) Annual
Meeting by Francesca Gay, Associate Professor at the University
Division of Hematology, AOU Città della Salute e della Scienza di
Torino, University of Torino and Department of Molecular
Biotechnology and Health Sciences - member of the Young EMN board
of directors.
MRD negativity is defined as the absence of
myeloma cells in the bone marrow after treatment, as measured by
diagnostic techniques that must have a sensitivity of at least 1 in
100,000 cells. In this trial, MRD negativity was detected with a
sensitivity of 10-5 (no cancer cells detected within 100,000 bone
marrow cells) and 10-6 (no cancer cells detected within 1,000,000
bone marrow cells).
In an intent-to-treat (ITT) analysis, the
primary endpoint of rate of MRD negativity using next generation
sequencing with a sensitivity of 10-5 after consolidation for
patients receiving Sarclisa combination therapy (n=151) was 77%
versus 67% for those who received KRd alone (n=151) (odds ratio
[OR] 1.67; p=0.049). The respective rates of MRD negativity at
sensitivity of 10-6 were 67% versus 48% (OR 1.93; p=0.006). The MRD
negativity benefit, both at 10-5 and 10-6 sensitivities, was
retained in all subgroups analyzed with similar benefit in both
standard-risk and high-risk patients.
There was a statistically significant difference
in MRD negativity rates after induction with Sarclisa in
combination with KRd versus KRd (10-5: 45% versus 26%, p<0.001;
10-6: 27% versus 14%, p=0.004).
The safety and tolerability of Sarclisa observed
in this trial were consistent with the observed safety profile of
Sarclisa in other clinical trials, with no new safety signals
observed. Rates of grade 3 or higher hematologic adverse events
(AEs) were 40% versus 30% and rates of non-hematologic AEs were 41%
versus 37% for the Sarclisa combination versus KRd, respectively.
Discontinuation rates for AEs were similar in both study arms (7%
and 5%, respectively). There were three treatment-related deaths in
the Sarclisa combination arm and one in the KRd arm.
Peter C. AdamsonGlobal
Development Head, Oncology, Sanofi
“The statistically significant rates of MRD
negativity observed with Sarclisa combination therapy further
support our belief in Sarclisa as a potential best-in-class
therapy. Effective front-line treatment is critical for newly
diagnosed patients, because achieving undetectable levels of
disease early in the treatment journey may lead to better long-term
outcomes. We look forward to our continued collaboration with the
EMN to explore the potential of this novel combination regimen for
those with transplant-eligible, newly diagnosed multiple
myeloma.”
The use of Sarclisa in combination with KRd in
this patient population is investigational and has not been
evaluated by any regulatory authority.
About the trial
The randomized, open-label Phase 3 IsKia trial
enrolled 302 patients with newly diagnosed, transplant-eligible MM
across eight countries and 42 sites in Europe. Patients were
randomized into two arms. Patients in both arms received induction
with four 28-day cycles of KRd followed by cyclophosphamide and
stem cell collections, chemotherapy with Melphalan 200 mg/m2
followed by ASCT (Mel200-ASCT), four 28-day cycles of KRd post ASCT
consolidation and 12 cycles of KRd light consolidation. Sarclisa
was added to KRd in one trial arm only. During the trial, 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 and full consolidation
periods, then every four weeks during light consolidation
period.
The primary endpoint was the rate of MRD
negativity by next-generation sequencing (10-5) after consolidation
in the ITT population. MRD was tested in all patients who achieved
at least a very good partial response. Key secondary endpoints were
the rate of next-generation sequencing MRD negativity (10-5) after
induction and progression free survival. MRD rates were evaluated
in an ITT analysis.
High-risk patient cytogenetics per the
International Myeloma Working Group (IMWG) criteria were defined as
the presence of t(4;14), t(14;16), or del(17p). High-risk
cytogenetic abnormality (HRCA) was defined as the presence of one
of the following abnormalities: del(17p13.1), t(4;14)
(p16.3;q32.3), t(14;16) (q32.3;q23), gain(1q21), or amp(1q21). Two
or more HRCAs was defined as the presence of at least two high-risk
cytogenetic abnormalities.
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).
The IsKia trial marks the second positive Phase
3 trial of Sarclisa in transplant-eligible newly diagnosed multiple
myeloma, and fifth positive Phase 3 readout for Sarclisa overall,
demonstrating its best-in-class potential.
Sarclisa continues to be evaluated in multiple
ongoing Phase 3 clinical trials 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
trials, please visit www.clinicaltrials.gov.
About multiple myeloma MM is the second
most common hematologic malignancy.1 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 European Myeloma Network (EMN)
foundation The European Myeloma Network (EMN) is a non-profit
organization, created in 2005. This network is the reference
organization for multiple myeloma studies in Europe: physicians can
participate in cooperative projects to increase and share their
experiences, and to standardize and harmonize clinical practices;
pharmaceutical companies can refer to the EMN as a general
interlocutor in Europe to plan and manage clinical trials with new
molecules; and, most importantly, patients can be enrolled in
clinical studies evaluating last-generation and promising drugs,
with the ultimate goal of improving their survival and quality of
life. Various national groups collaborate within the EMN, such as
the Netherlands (where the headquarter is located), Italy (with the
data centre of the network), Germany, Austria, France, Spain,
Greece, Czech Republic, the UK, Norway, Denmark, Switzerland,
Turkey, and many more countries will participate in the EMN
projects in the future. For further information, please contact the
EMN (President Prof. Pieter
Sonneveld): https://www.myeloma-europe.org/
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 some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
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Media RelationsSally
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1 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.
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