European Commission approves Sarclisa® (isatuximab) for adults with
relapsed and refractory multiple myeloma
European Commission approves Sarclisa® (isatuximab) for
adults with relapsed and refractory multiple myeloma
- EC approval based on data from first randomized Phase 3 trial
(ICARIA-MM) to report results evaluating an anti-CD38 monoclonal
antibody combined with pomalidomide and dexamethasone
(pom-dex)
- Sarclisa in combination with pom-dex significantly reduced the
risk of progression or death by 40% versus pom-dex alone
- Multiple myeloma is the second most common blood cancer, with
approximately 40,000 new cases per year in Europe
PARIS – June 2, 2020 – The
European Commission (EC) has approved Sarclisa® (isatuximab) in
combination with pomalidomide and dexamethasone (pom-dex) for the
treatment of adult patients with relapsed and refractory multiple
myeloma (MM) who have received at least two prior therapies
including lenalidomide and a proteasome inhibitor and have
demonstrated disease progression on the last therapy.
Sarclisa is a monoclonal antibody (mAb) that
binds to a specific epitope on the CD38 receptor of MM cells. “The
EC approval of Sarclisa represents an important additional
therapeutic option and may set a new standard of care for myeloma
patients in Europe who are in need of new effective treatments
because their disease has returned or they have become refractory
to their previous treatment,” said John Reed, M.D., Ph.D., Global
Head of Research and Development at Sanofi. “Sarclisa in
combination with pom-dex demonstrated median progression-free
survival of nearly one year, a five-month improvement over pom-dex
alone, in patients who had already failed at least two prior
therapies.”
Sarclisa Efficacy and Safety Profile in
Difficult-to-Treat Patients
In the Phase 3 ICARIA-MM study, Sarclisa added
to pom-dex (Sarclisa combination therapy, n=154) demonstrated a
statistically significant improvement of progression-free survival
(PFS), with a median PFS of 11.53 months compared to 6.47 months
with pom-dex alone (n=153) (HR 0.596, 95% CI: 0.44-0.81, p=0.001).
Sarclisa combination therapy also demonstrated a significantly
greater overall response rate compared to pom-dex alone (60.4% vs.
35.3%, p<0.0001). In additional analyses, Sarclisa combination
therapy compared to pom-dex alone showed a treatment benefit
consistent across select subgroups reflective of real-world
practice, including patients with high risk cytogenetics, those
aged 75 years and older, patients with renal insufficiency and
patients who were refractory to lenalidomide.
“As patients experience relapse of their
multiple myeloma or become refractory to their current therapy,
they become more difficult to treat with increasingly poor
prognoses. In the ICARIA-MM trial, Sarclisa combination therapy
showed a treatment benefit consistent across relapsed and
refractory multiple myeloma subgroups,” said Philippe Moreau, M.D.,
Department of Hematology, University Hospital of Nantes, France.
“Sarclisa offers an important new treatment option and a
potentially new standard of care for these patients with relapsed,
refractory disease.”
As outlined in the Summary of Product
Characteristics (SmPC), the most frequent adverse reactions
observed with Sarclisa (occurring in 20% or more of patients) are
neutropenia (46.7%), infusion reactions (38.2%), pneumonia (30.9%),
upper respiratory tract infection (28.3%), diarrhea (25.7%) and
bronchitis (23.7%). The most frequent serious adverse reactions are
pneumonia (9.9%) and febrile neutropenia (6.6%).
For more information on the safety of Sarclisa,
please refer to the SmPC.
An Important New Option for Treating
Multiple Myeloma
Sarclisa is administered by intravenous (IV)
administration and is dosed at 10 mg/kg, in combination with
pom-dex, every week for four weeks and then every two weeks, until
disease progression or unacceptable toxicity. Assuming no rate
adjustments based on infusion-related reactions, the first infusion
takes three to four hours, the second infusion takes less than two
hours, and the remaining infusions can decrease to 75 minutes from
the third infusion onwards. A treatment cycle is 28 days. The EC
marketing authorization for Sarclisa is applicable to the 27 member
states of the European Union (EU), plus the UK, Iceland,
Liechtenstein and Norway.
Multiple Myeloma: A Significant Burden to
Patients
MM is the second most common hematologic
malignancy,1 with more than 138,000 new cases worldwide each year.2
In Europe, approximately 40,000 patients are diagnosed with MM
yearly.3 MM remains incurable in the vast majority of patients,
resulting in significant disease burden.
About Sarclisa
Sarclisa is a mAb that binds to a specific
epitope on the CD38 receptor. CD38 is highly and uniformly
expressed on MM cells, making it a potential target for
antibody-based therapeutics such as Sarclisa. It is designed to
induce programmed tumor cell death (apoptosis) and immunomodulatory
activity.
In addition to the EU, Sarclisa has also been
approved in the 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.
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Media Relations Contact Ashleigh Koss Tel.: +1
908-981-8745Ashleigh.Koss@sanofi.com |
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45 ir@sanofi.com |
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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 International Myeloma Foundation. Myeloma Action Month.
http://mam.myeloma.org/educate/.Accessed January 2019. 2/6.
3 João C, Costa C, Coelho I, Vergueiro MJ, Ferreira M, Silva MG.
Long‐term survival in multiple myeloma. Clinical Case Reports.
2014;2(5):173-179. doi:10.1002/ccr3.76. 3. Schey SA, Morris J,
Maguire Á, Dhanasiri
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