Press Release: Sarclisa® (isatuximab) combination provides
unprecedented median progression free survival in patients with
relapsed multiple myeloma receiving a proteasome inhibitor therapy
Sarclisa® (isatuximab) combination provides unprecedented median
progression free survival in patients with relapsed multiple
myeloma receiving a proteasome inhibitor therapy
-
Latest results of the Phase 3 IKEMA trial demonstrate the longest
median progression free survival (mPFS) on a proteasome inhibitor
backbone in patients who relapsed after a prior therapy, including
lenalidomide
- The
median progression free survival, increased from 19.2 months to
35.7 months when Sarclisa was added to carfilzomib and
dexamethasone
-
Further analysis, following U.S. Food and Drug Administration
recommendations on censoring rules, showed mPFS increased from 20.8
to 41.7 months when Sarclisa was added to carfilzomib and
dexamethasone
PARIS, May
15,
2022. Latest results from the Phase 3 IKEMA
clinical trial evaluating Sarclisa® (isatuximab) in combination
with carfilzomib and dexamethasone (Kd) demonstrated a median
progression free survival (mPFS) of 35.7 months (Hazard Ratio [HR]
0.58; 95% Confidence Interval [CI]: 25.8 to 44.0; n=179), compared
to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to
25.1; n=123), as evaluated by an Independent Review Committee.
These results, presented at the Controversies in Multiple Myeloma
World Congress, represent the longest mPFS among studies
investigating a proteasome inhibitor backbone in the second-line
setting for the treatment of relapsed multiple myeloma (MM). These
data will also be presented at the European Society for Medical
Oncology on May 19.
Philippe Moreau,
MDHead of the Department of Hematology, University
Hospital of Nantes, France“The increase in progression free
survival, observed consistently across all subgroups, when adding
Sarclisa to carfilzomib and dexamethasone is remarkable in patients
with relapsed multiple myeloma in a proteasome inhibitor
combination. Relapse is common in multiple myeloma, creating the
need for differentiated second-line treatments that provide
patients a longer period of time without disease progression. This
updated analysis reinforces the potential for Sarclisa to become a
new standard of care for patients with relapsed multiple
myeloma.”
A PFS analysis following the U.S. Food and Drug
Administration recommendations on censoring rules, as applied in
the approved U.S. prescribing information, showed an mPFS of 41.7
months for Sarclisa added to Kd (Sarclisa combination therapy)
compared to 20.8 months in patients treated with Kd alone (HR 0.59;
95% CI: 27.1 to Not Calculable [NC]).
Time to next treatment for patients treated with
Sarclisa combination therapy was 44.9 months (HR 0.55; 95% CI: 31.6
to NC) versus those treated with Kd alone at 25 months (95% CI:
17.9 to 31.3). Time to next treatment measured the interval from
the date of randomization1 to the date of commencement of the next
line of therapy, thereby allowing for measurement of the period of
therapeutic benefit.2
Peter C. Adamson, MDGlobal Head
of Oncology Clinical Development and Pediatric Innovation at
Sanofi“To observe progression free survival of more than three
years in patients with relapsed multiple myeloma when Sarclisa was
added to a proteasome inhibitor backbone of therapy is
unprecedented and reinforces our confidence in Sarclisa as a
potential best in class anti-CD38 antibody.”
The safety and tolerability of Sarclisa observed
in this analysis were consistent with the safety profile of
Sarclisa in other clinical trials, with no new safety signals
observed. For the Sarclisa combination therapy and Kd groups, the
most common adverse events were infusion related reaction (45.8%,
3.3%), diarrhea (39.5%, 32%), hypertension (37.9%, 35.2%), upper
respiratory tract infection (37.3%, 27%), fatigue (31.6%, 20.5%),
dyspnoea (30.5%, 22.1%), pneumonia (27.1%, 21.3%), back pain
(25.4%, 21.3%), insomnia (25.4%, 24.6%), and bronchitis (24.3%,
12.3%). Treatment exposure in the Sarclisa combination therapy arm
was 30 weeks longer than in the control arm. Treatment emergent
adverse events (TEAEs) of ≥ Grade 3 were reported in 83.6% of
patients treated with Sarclisa combination therapy and in 73% of
those treated with Kd alone. Serious TEAEs were higher in the
Sarclisa combination therapy arm versus Kd alone (70.1% versus
59.8%). No difference was observed after exposure adjustment.”
These results will be discussed with regulatory
authorities at a future date.
About the IKEMA trial
The randomized, multi-center, open label Phase 3
IKEMA clinical trial enrolled 302 patients with relapsed MM across
69 centers spanning 16 countries. All study participants had
received one to three prior anti-myeloma therapies. 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 carfilzomib twice weekly at
the 20/56mg/m2 dose and dexamethasone at the standard dose for the
duration of treatment. The primary endpoint of IKEMA was
progression free survival. Secondary endpoints included overall
response rate, the rate of complete response or better, the rate of
very good partial response or better, rate of minimal residual
disease-negativity, overall survival and safety.3
About Sarclisa
Sarclisa is a monoclonal antibody that targets a
specific epitope on the CD38 receptor on multiple myeloma (MM)
cells. 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 potential target for
antibody-based therapeutics such as Sarclisa.
Based on the Phase 3 ICARIA-MM study, Sarclisa
is approved in a number of countries, including the U.S. and 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.
Based on the Phase 3 IKEMA study, Sarclisa is also approved in
multiple 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).
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 solid tumors. The safety and efficacy of these
additional uses have not been reviewed by any regulatory authority
worldwide.
For more information on Sarclisa clinical
trials, please visit www.clinicaltrials.gov.
About multiple myeloma
MM is the second most common hematologic
malignancy,4 with more than 130,000 new diagnoses of MM worldwide
yearly.5 Despite available treatments, MM remains an incurable
malignancy and is associated with significant patient burden. 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 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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ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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1 ClincalTrials.gov. Identifier #
NCT03275285.https://www.clinicaltrials.gov/ct2/show/NCT03275285?term=IKEMA&draw=2&rank=1.
Accessed April 2022. 2 Campbell. Time to Next Treatment as a
Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma.
Cancers vol. 12,8 2311. 17 Aug. 2020, doi:10.3390/cancers12082311.3
ClinicalTrials.gov. Identifier # NCT03275285.
https://www.clinicaltrials.gov/ct2/show/NCT03275285?cond=NCT03275285&draw=2&rank=1.
Accessed April 2022.4 Kazandjian. Multiple myeloma epidemiology and
survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004.5 International Myeloma
Foundation. Myeloma Action Month.
https://mam.myeloma.org/learn-more-about-multiple-myeloma/.
Accessed April 2022.
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