Sarclisa® (isatuximab) combination therapy demonstrated superior
progression free survival and clinically meaningful depth of
response in patients with relapsed multiple myeloma
Sarclisa® (isatuximab) combination therapy demonstrated
superior progression free survival and clinically meaningful depth
of response in patients with relapsed multiple
myeloma
- Sarclisa added to carfilzomib and dexamethasone (Sarclisa
combination) reduced risk of disease progression or death by 47%
versus standard of care carfilzomib and dexamethasone (Kd)
alone
- Sarclisa combination therapy delivered considerable depth of
response, with undetectable levels of multiple myeloma (MM) in
nearly 30% of patients with relapsed MM (MRD-negative 10-5
sensitivity)
- Results from first planned interim analysis of the Phase 3
IKEMA trial selected as late-breaking presentation at EHA25 Virtual
Congress
PARIS – June 2, 2020 –
Sarclisa® (isatuximab) added to carfilzomib and dexamethasone
(Sarclisa combination therapy) reduced the risk of disease
progression or death by 47% (hazard ratio 0.531, 99% CI
0.318-0.889, p=0.0007, n=179) compared to standard of care
carfilzomib and dexamethasone (Kd) in patients (n=123) with
relapsed multiple myeloma (MM). Sarclisa combination therapy
compared to Kd alone showed a treatment benefit consistent across
multiple subgroups.
These results from the Phase 3 IKEMA trial
follow the topline announcement on May 12, 2020 that Sarclisa
combination therapy met the trial primary endpoint at the
pre-planned interim analysis. Interim results will be presented
during the late-breaking session of the European Hematology
Association (EHA) Virtual Congress (EHA25) on June 14, 2020 and
will form the basis for global regulatory submissions later this
year.
“In the Phase 3 IKEMA trial, the addition of
Sarclisa to carfilzomib and dexamethasone reduced the risk of
disease progression or death by 47 percent compared to treatment
with carfilzomib and dexamethasone alone,” said Philippe Moreau,
M.D., Department of Hematology, University Hospital of Nantes,
France. “These results suggest the potential of Sarclisa to become
a new standard of care in the relapsed multiple myeloma
setting.”
While median progression free survival (PFS),
defined as time to disease progression or death, for Kd was 19.15
months, the median PFS for patients receiving Sarclisa combination
therapy had not been reached at the time of the pre-planned interim
analysis. The safety and tolerability of Sarclisa observed in this
trial was consistent with the observed safety profile of Sarclisa
in other clinical trials, with no new safety signals observed.
“This is the second Phase 3 trial to demonstrate
superior results with Sarclisa combination therapy over a standard
of care regimen, adding to the growing body of evidence that our
anti-CD38 monoclonal antibody has the potential to make a
meaningful difference for patients,” said John Reed, M.D., Ph.D.,
Global Head of Research and Development at Sanofi. “We believe
Sarclisa has the potential to become the anti-CD38 of choice for
the treatment of multiple myeloma. We look forward to seeing the
results from future clinical trials to understand the impact of
Sarclisa in earlier stages of disease.”
Depth of Disease Response with Sarclisa
Combination Therapy
Secondary endpoints of the IKEMA trial examined
the consistency and depth of response for Sarclisa combination
therapy compared to Kd, including overall response rate (ORR),
complete response (CR), very good partial response (VGPR) and
minimal residual disease (MRD)-negative response. There was no
statistically significant difference in ORR, which remained similar
for each arm at 86.6% for the Sarclisa combination versus 82.9% for
Kd (p=0.1930). The rate of CR was 39.7% in the Sarclisa combination
arm and 27.6% in the Kd arm. The rate of VGPR was 72.6% for
patients receiving Sarclisa combination therapy and 56.1% for
patients receiving Kd. MRD-negative complete response was observed
in 29.6% of patients in the Sarclisa combination arm versus 13% of
patients in the Kd arm, indicating that nearly 30% of patients
treated with Sarclisa combination therapy achieved undetectable
levels of MM at 10-5 sensitivity as measured by next generation
sequencing (NGS). At the time of the interim analysis, overall
survival (OS) data were still immature.
In this trial, treatment emergent adverse events
(TEAEs) of Grade ≥3 were observed in 76.8% of patients treated with
Sarclisa combination therapy versus 67.2% of patients treated with
Kd. Treatment-emergent serious adverse events (SAEs) and fatal
TEAEs were similar in the Sarclisa combination therapy arm versus
the Kd arm, reporting 59.3% versus 57.4% and 3.4% versus 3.3%,
respectively. Infusion reactions were reported in 45.8% (0.6% Grade
3-4) of patients treated with Sarclisa combination therapy versus
3.3% (0% Grade 3-4) of patients treated with Kd. Respiratory
infections of Grade ≥3 were seen in 32.2% of patients in the
Sarclisa combination therapy arm versus 23.8% of patients in the Kd
arm, and cardiac failure Grade ≥3 was reported in 4.0% for Sarclisa
combination therapy versus 4.1% for Kd. Grade 3-4 thrombocytopenia
and neutropenia were 29.9% for Sarclisa combination therapy versus
23.8% for Kd, and 19.2% for Sarclisa combination therapy versus
7.4% for Kd. Main reasons for treatment discontinuation were
disease progression (29.1% for Sarclisa combination therapy versus
39.8% for Kd) and AEs (8.4% for Sarclisa combination therapy versus
13.8% for Kd).
About the 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 PFS.
Secondary endpoints included ORR, the rate of CR or better, the
rate of VGPR or better, rate of MRD-negativity, OS and safety.1
The results from IKEMA are anticipated to form
the basis of regulatory submissions planned for later this year.
The use of Sarclisa in combination with carfilzomib and
dexamethasone in relapsed MM is investigational and has not been
evaluated by any regulatory authority.
About Sarclisa
Sarclisa is a monoclonal antibody that binds to
a specific epitope on the CD38 receptor on 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.
Sarclisa is approved in the EU, U.S.,
Switzerland, Canada and Australia in combination with pom-dex for
the treatment of certain adults with relapsed refractory MM. 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.
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)
MM is the second most common hematologic
malignancy, with more than 138,000 new diagnoses of MM worldwide
yearly.2,3 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.
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With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. Sanofi, Empowering Life |
Media Relations Contact Sally Bain Tel.: +1
(781) 264-1097Sally.Bain@sanofi.com |
Investor
Relations Contact Felix Lauscher Tel.: +33 (0)1 53 77 45
45 ir@sanofi.com |
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1 ClinicalTrials.gov. Identifier # NCT03275285.
https://www.clinicaltrials.gov/ct2/show/NCT03275285?cond=NCT03275285&draw=2&rank=1.
Accessed June 2020.
2 Kazandjian. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004.
3 International Myeloma Foundation. Myeloma Action Month.
https://mam.myeloma.org/learn-more-about-multiple-myeloma/.
Accessed June 2020.
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