-- In more than 70 percent of patients, disability scores improved or
remained stable over three years --
-- More than 80 percent of patients treated with LEMTRADA did not
receive a third course of treatment in the first year of the extension
MISSISSAUGA, ON, March 28, 2013 /CNW/ - Genzyme, a Sanofi Company
announced interim results from the first year of the extension study of
LEMTRADA™ (alemtuzumab), being developed for the treatment for multiple
sclerosis (MS). The data were presented March 21 at the American
Academy of Neurology meeting in San Diego, California.
In this analysis of the first year of the extension study, relapse rates
and sustained accumulation of disability remained low among patients
who had previously received LEMTRADA in either of the Phase III CARE-MS
I and CARE-MS II studies. In these pivotal studies, LEMTRADA was given
as two annual courses, at the start of the study and 12 months later.
More than 80 percent of patients did not receive further treatment with
LEMTRADA during the first year of the extension study.
"These findings are important because they suggest that the benefits of
LEMTRADA as observed in the Phase III studies are maintained, even
though most patients did not receive further dosing," said Edward Fox, M.D., Director of the Multiple Sclerosis Clinic of
Central Texas, who presented the study.
"These results clearly show that LEMTRADA is interesting as a treatment
option for relapsing-remitting MS for three reasons. First, it reduces
the relapse rate to a greater degree than an active comparator. Second,
disability remains stable or improves in most patients for at least up
to three years. Third, the drug usually only requires five infusions in
the first year and three infusions in the second year for long term
efficacy," said François Grand'Maison, MD, neurologist at Hôpital Charles
LeMoyne and director of the Neuro Rive-Sud MS Clinic in Greenfield
"However LEMTRADA may cause auto-immune reactions for which frequent
blood monitoring is required. Fortunately, these reactions are easily
treated. Overall, it is likely that this drug will make it easier for
MS patients to deal with their disease and go on with their lives."
Extension Study Results
The Phase III trials of LEMTRADA were randomized, two-year pivotal
studies comparing treatment with LEMTRADA to Rebif® (subcutaneous interferon beta-1a 44 mcg) in patients with
relapsing-remitting MS who were either new to treatment (CARE-MS I) or
who had relapsed while on prior therapy (CARE-MS II).
More than 90 percent of the patients who participated in the Phase III
pivotal trials enrolled in the extension study. Patients who originally
received LEMTRADA were eligible to receive additional treatment in the
extension study if they experienced at least one relapse or at least
two new or enlarging brain or spinal lesions.
These interim results are from the first year of the extension study for
patients who previously received LEMTRADA in the two-year studies.
Findings stated below are based on patients who enrolled in the
More than half of patients (67 percent in CARE-MS I and 55 percent in
CARE-MS II) who received LEMTRADA in the pivotal trials and enrolled in
the extension study were still relapse-free through the first year of
the extension study.
In the first year of the extension phase, the annualized relapse rate
for patients who received LEMTRADA in the pivotal trials was 0.24 and
0.25, comparable to the annualized relapse rate for those patients in
CARE MS I and CARE-MS II, respectively.
Through year three, 72.4 percent of patients in CARE MS I and 70.0
percent in CARE MS II had improved or stable disability as measured by
At three years, 88 percent and 80 percent of patients who received
LEMTRADA in the pivotal trials, respectively, did not experience
six-month confirmed sustained accumulation of disability.
More than 80 percent of patients treated with LEMTRADA in the pivotal
studies did not receive a third course of treatment within a year of
entering the extension study.
"These results underscore the tremendous promise that LEMTRADA holds for
MS patients," said David Meeker, M.D., Genzyme's President and Chief Executive
Officer. "We're pleased to be able to present these three-year results that
provide us with important new information about LEMTRADA and are
consistent with the published results from our Phase II extension
Safety results from the first year of the extension study were reported
for patients who received LEMTRADA in the Phase III pivotal studies. No
new risks were identified. The frequency and type of common and serious
adverse events in the first year of the extension study were generally
similar to those in the Phase III pivotal studies. The most common
adverse events during this period of time were infections, including
predominantly mild to moderate upper respiratory and urinary tract
infections. There were two deaths. One, as previously reported, was
from sepsis. The other death was presumed accidental and deemed
unrelated to study treatment. The cumulative incidence of autoimmune
thyroid disease over three years was 29.9 percent, as expected based on
the Phase II study experience. Additionally, over three years,
approximately 1 percent of patients developed immune thrombocytopenia
(ITP) and 0.3 percent developed nephropathy, all of whom responded to
treatment. These cases were detected early through routine monitoring.
Patient monitoring for autoimmune disorders is incorporated in all
Genzyme-sponsored trials of LEMTRADA.
The CARE-MS trials are Phase III, global, randomized clinical trials
designed to evaluate whether the investigational MS therapy LEMTRADA
could achieve meaningful efficacy and safety improvements over the
approved, active comparator Rebif (subcutaneous interferon beta-1a 44
mcg), a standard treatment for relapsing-remitting MS. The CARE-MS I
study evaluated 581 patients naïve to prior MS treatment, except for
steroids. The CARE-MS II study evaluated 840 patients who have had at
least one relapse occurring while on MS therapy, including standard
injectable disease modifying therapies. Genzyme announced publication
of results of these studies in The Lancet in November 2012.
In the both trials, LEMTRADA was given as an IV administration a total
of eight times over the course of the two-year study. The first
treatment course of LEMTRADA was administered on five consecutive days,
and the second course was administered on three consecutive days 12
months later. Rebif 44 mcg was administered by subcutaneous injection
three times per week, each week, throughout the two years of study.
In the third-year following initial treatment, starting the extension
phase of the trials, patients who experienced resumed disease activity
were retreated with LEMTRADA once daily for three days. Patients who
took Rebif in the pivotal study phase and crossed over to receive
LEMTRADA in the extension phase received LEMTRADA once daily for five
days and then once daily for three days one year later.
About LEMTRADA™ (alemtuzumab)
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a
protein abundant on T and B cells. Treatment with alemtuzumab results
in the depletion of circulating T and B cells thought to be responsible
for the damaging inflammatory process in MS. Alemtuzumab has minimal
impact on other immune cells. The acute anti-inflammatory effect of
alemtuzumab is immediately followed by the onset of a distinctive
pattern of T and B cell repopulation that continues over time,
rebalancing the immune system in a way that potentially reduces MS
Genzyme holds the worldwide rights to alemtuzumab and has primary
responsibility for its development and commercialization in multiple
sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab
in multiple sclerosis. Bayer HealthCare has notified Genzyme of its
intention to co-promote under this option. Upon regulatory approval and
commercialization, Bayer would receive contingent payments based on
LEMTRADATM is the proprietary name submitted to health authorities for the
company's investigational multiple sclerosis agent alemtuzumab.
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.
Sanofi, a global and diversified 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
Genzyme® is the registered trademark of Genzyme Corporation. All rights
Rebif® is a registered trademark of EMD Serono, Inc. or affiliates.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer
HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2
billion (2011), is one of the world's leading, innovative companies in
the healthcare and medical products industry and is based in
Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare's aim is to discover, develop, manufacture
and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,700 employees
(Dec 31, 2011) and is represented in more than 100 countries. Find more
information at www.bayerhealthcare.com.
SOURCE: Genzyme, a Sanofi Company
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