Effect of Genzyme's LEMTRADA Maintained in Patients Beyond Two-Year Pivotal MS
-- 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 Park, Québec.
"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 extension study:
-- 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,
-- 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 EDSS.
-- 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
-- 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 study."
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
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
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 disease activity.
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 sales revenue.
LEMTRADA(TM) 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
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 (NYSE: SNY).
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
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