- Approximately 70% of Lemtrada Patients Had
Not Received Any Additional Lemtrada Treatment in the Prior Three
Years -
Genzyme, a Sanofi company, announced that new magnetic resonance
imaging (MRI) data from the Lemtrada® (alemtuzumab) clinical
development program will be presented today at the 67th American
Academy of Neurology (AAN) Annual Meeting.
In relapsing remitting multiple sclerosis (RRMS) patients
treated with Lemtrada in the Phase III pivotal studies, MRI effects
observed in the two-year trials were maintained through two
additional years in the extension study (years three and four).
After the initial two courses of treatment in the pivotal studies,
which were given at month zero and at month 12, approximately 70
percent of Lemtrada patients did not receive additional Lemtrada
treatment during the following three years, through month 48.
The Phase III trials of Lemtrada were randomized, two-year
pivotal studies comparing treatment with Lemtrada to high-dose
subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who
had active disease and were either new to treatment (CARE-MS I) or
who had an inadequate response to another therapy (CARE-MS II).
Through year four, the adverse event profile of Lemtrada was
consistent with that observed during the pivotal studies. The new
data being presented at AAN include:
- The rate of brain atrophy, as measured
by brain parenchymal fraction (BPF), decreased progressively over
four years among Lemtrada patients in CARE-MS I. Among CARE-MS II
Lemtrada patients, the rate of brain atrophy decreased
progressively over three years and remained low in year four. In
both studies, the median yearly brain volume loss was less than
-0.20% in years three and four, which was lower than what was
observed during the two-year pivotal studies.
- In CARE-MS I and II, treatment with
Lemtrada significantly reduced the risk of developing new lesions
compared to interferon beta-1a. In the extension study, most of the
Lemtrada-treated patients from CARE-MS I and II were free of new
lesions and MRI activity in years three and four (approximately
70%).
Brain atrophy is a measure of the most destructive pathological
processes that occur in MS.1 It is seen from the earliest stages of
disease and may lead to irreversible neurological and cognitive
impairment. Given its association with disability, control or
prevention of brain atrophy is an important target for MS
treatment. In addition, MRI measures including lesion activity are
considered useful tools when evaluating the effect of MS therapies,
and lesion activity is among several prognostic factors for
unfavorable clinical outcomes. 2
“It is very promising that most Lemtrada patients experienced
slowing of brain atrophy and remained free of new lesions despite
receiving their last treatment course three years previously,” said
Dr. Alasdair Coles, Professor, Department of Clinical
Neurosciences, University of Cambridge. “These new MRI data are
consistent with the clinical data from the extension study that
provide additional evidence of the sustained efficacy of Lemtrada
on both relapses and disability.”
Safety results from the second year of the extension study were
previously reported. No new risks were identified. The most common
side effects of Lemtrada are rash, headache, pyrexia,
nasopharyngitis, nausea, urinary tract infection, fatigue,
insomnia, upper respiratory tract infection, herpes viral
infection, urticaria, pruritus, thyroid gland disorders, fungal
infection, arthralgia, pain in extremity, back pain, diarrhea,
sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal
pain, flushing, and vomiting. Other serious side effects associated
with Lemtrada include autoimmune thyroid disease, autoimmune
cytopenias, infections and pneumonitis. A risk management program
incorporating education and monitoring helps support early
detection and management of these identified risks (see Important
Safety Information About Lemtrada for U.S. Patients below).
“The four-year MRI data support the prolonged efficacy of
Lemtrada,” said Genzyme President and CEO, David Meeker, M.D.
“These results are encouraging, as they provide further evidence of
Lemtrada’s potential to change the treatment approach for people
living with relapsing forms of MS.”
More than 90 percent of the patients who were treated with
Lemtrada in the CARE-MS Phase III trials enrolled in the extension
study. These patients were eligible to receive additional treatment
with Lemtrada in the extension study if they experienced at least
one relapse or at least two new or enlarging brain or spinal cord
lesions. MRI scans were taken at CARE-MS baseline, and at 12, 24,
36 and 48 months.
In CARE-MS I, Lemtrada was significantly more effective than
interferon beta-1a at reducing annualized relapse rates; the
difference observed in slowing disability progression did not reach
statistical significance. In CARE-MS II, Lemtrada was significantly
more effective than interferon beta-1a at reducing annualized
relapse rates, and accumulation of disability was significantly
slowed in patients given Lemtrada vs. interferon beta-1a.
Lemtrada® (alemtuzumab) U.S. Indication and
Usage
Lemtrada is indicated in the United States for the treatment of
patients with relapsing forms of multiple sclerosis (MS). Because
of its safety profile, the use of Lemtrada should generally be
reserved for patients who have had an inadequate response to two or
more drugs indicated for the treatment of MS. Lemtrada is
contraindicated in patients who are infected with Human
Immunodeficiency Virus (HIV) because Lemtrada causes prolonged
reductions of CD4+ lymphocyte counts.
Please click here for full U.S. Prescribing
Information for Lemtrada, including boxed warning and
contraindications.
Important Safety Information About Lemtrada for U.S.
Patients
Serious and life-threatening autoimmune conditions such as
immune thrombocytopenia (ITP) and anti-glomerular basement membrane
disease can occur in patients receiving Lemtrada. Monitor complete
blood counts with differential, serum creatinine levels, and
urinalysis with urine cell counts at periodic intervals in patients
who receive Lemtrada. Lemtrada is associated with serious and
life-threatening infusion reactions. Lemtrada can only be
administered in certified healthcare settings that have on-site
access to equipment and personnel trained to manage anaphylaxis and
serious infusion reactions. Lemtrada may be associated with an
increased risk of malignancy, including thyroid cancer, melanoma
and lymphoproliferative disorders. The Lemtrada REMS Program, a
risk management program with frequent monitoring, has been
implemented to help mitigate these serious risks.
The Lemtrada label includes a boxed warning noting a risk of
serious, sometimes fatal autoimmune conditions, serious and
life-threatening infusion reactions and also noting Lemtrada may
cause an increased risk of malignancies including thyroid cancer,
melanoma and lymphoproliferative disorders. Lemtrada is
contraindicated in patients with Human Immunodeficiency Virus (HIV)
infection.
About Lemtrada® (alemtuzumab)
Lemtrada is approved in more than 40 countries, with additional
marketing applications under review. Lemtrada is supported by a
comprehensive and extensive clinical development program that
involved nearly 1,500 patients and 5,400 patient-years of
follow-up.
Alemtuzumab is a monoclonal antibody that targets CD52, a
protein abundant on T and B cells. Circulating T and B cells are
thought to be responsible for the damaging inflammatory process in
MS. Although the exact mechanism of action for alemtuzumab is
unknown, it is presumed to deplete circulating T and B lymphocytes
after each treatment course. Lymphocyte counts then increase over
time with a reconstitution of the lymphocyte population that varies
for the different lymphocyte subtypes.
Genzyme holds the worldwide rights to alemtuzumab and has
responsibility for its development and commercialization in
multiple sclerosis. Bayer Healthcare receives contingent payments
based on global sales revenue.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of
transformative therapies for patients affected by rare and
debilitating diseases for over 30 years. We accomplish our goals
through world-class research and with the compassion and commitment
of our employees. With a focus on rare diseases and multiple
sclerosis, we are dedicated to making a positive impact on the
lives of the patients and families we serve. That goal guides and
inspires us every day. Genzyme’s portfolio of transformative
therapies, which are marketed in countries around the world,
represents groundbreaking and life-saving advances in medicine. As
a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at
www.genzyme.com.
Genzyme® and Lemtrada® are registered trademarks of
Genzyme Corporation. Rebif® is a registered trademark of EMD
Serono, Inc. All rights reserved.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in the field of healthcare with seven
growth platforms: diabetes solutions, human vaccines, innovative
drugs, consumer healthcare, emerging markets, animal health and the
new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
References
(1) American Journal of Neuroradiology, August 2014
http://ajnrdigest.org/brain-atrophy-multiple-sclerosis/
(2) Cleveland Clinic, Center For Continuing Education, Medical
Publications, Multiple Sclerosis, June 2014
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/neurology/multiple_sclerosis/
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Genzyme Media RelationsErin Pascal, + 1
857-248-0874erin.pascal@genzyme.comorSanofi Media
RelationsJack Cox, +33 (0) 1 53 77 46
46mr@sanofi.comorSanofi Investor RelationsSébastien Martel,
+33 (0) 1 53 77 45 45ir@sanofi.com
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