Results observed in these patients through
six years were similar to those in patients who did not relapse
between courses
Sanofi Genzyme, the specialty care global business unit of
Sanofi, announced today positive new six-year investigational data
from a post-hoc analysis of the extension study of
Lemtrada® (alemtuzumab) in patients with relapsing
remitting multiple sclerosis (RRMS). These data will be presented
at the 69th American Academy of Neurology (AAN) Annual Meeting.
Lemtrada is administered as two annual treatment courses, with
the first treatment course administered via intravenous infusion on
five consecutive days, and the second course administered on three
consecutive days, twelve months later.
The majority of patients treated with Lemtrada (76%; n=330) in
the Phase III pivotal study CARE-MS II did not relapse between
their first and second courses of Lemtrada; 24% (n=105) of
Lemtrada-treated patients in CARE-MS II relapsed between
courses.
Clinical and MRI outcomes in the Lemtrada-treated patients who
relapsed between courses markedly improved after their second
course. Through six years, the clinical and MRI results observed in
these patients were similar to those in the patients who did not
relapse between courses:
- Annualized relapse rate (ARR):
- In patients who relapsed between
courses, ARR declined from 1.2 in year 1 to 0.5 in year 2, after
they received their second treatment course. ARR continued to
decline through year 6 (years 3, 4, 5 and 6: 0.4, 0.4, 0.3, and
0.2, respectively.)
- In patients who did not relapse between
courses, ARR in years 2, 3, 4, 5, and 6 was 0.2, 0.2, 0.2, 0.2 and
0.1, respectively.
- Confirmed disability worsening (CDW),
defined as ≥ 1-point Expanded Disability Status Scale (EDSS)
increase (or ≥ 1.5 points if baseline EDSS=0) confirmed over six
months:
- The majority of patients who relapsed
between courses (80%) were free of CDW in year 2, and 60% remained
free of CDW in year 6.
- The majority of patients who did not
relapse between courses (91%) were free of CDW in year 2, and 75%
remained free of CDW in year 6.
- Confirmed disability improvement (CDI),
defined as ≥ 1-point EDSS decrease from baseline (patients with
baseline score ≥ 2.0) confirmed over six months:
- In year 2, 28% of patients who relapsed
between courses achieved CDI, and the proportion achieving CDI in
years 3, 4, 5 and 6 was 33%, 34%, 34% and 34%, respectively.
- In year 2, 31% of patients who did not
relapse between courses achieved CDI, and the proportion achieving
CDI in years 3, 4, 5 and 6 was 37%, 43%, 44% and 45%,
respectively.
- No evidence of disease activity (NEDA),
defined as absence of clinical disease activity (relapses and
six-month CDW) and MRI disease activity (new Gd-enhancing T1 and
new/enlarging T2 hyperintense lesions):
- In patients who relapsed between
courses, the proportion achieving NEDA was 38% in year 2 and 58% in
year 6.
- In patients who did not relapse between
courses, the proportion achieving NEDA was 64% in year 2 and 60% in
year 6.
- Brain volume loss (BVL), derived by
relative change in brain parenchymal fraction:
- In patients who relapsed between
courses, median percent yearly BVL was -0.10% in year 2, and
remained low in years 3, 4, 5 and 6 (-0.07%, -0.19%, -0.29%, and
-0.13%, respectively).
- In patients who did not relapse between
courses, median percent yearly BVL was -0.27% in year 2, and
remained low in years 3, 4, 5 and 6 (-0.12%, -0.19%, -0.01% and
-0.10%, respectively.)
Retreatment data for both groups of patients is as follows:
- 33% of patients who relapsed between
courses received no additional treatment after course two through
year six; 53% received retreatment with Lemtrada, 7% percent
received retreatment with another disease-modifying therapy (DMT),
and 7% received retreatment with Lemtrada and another DMT.
- 55% of patients who did not relapse
between courses received no additional treatment after course two
through year six; 36% received retreatment with Lemtrada, 4%
received retreatment with another DMT, and 5% received retreatment
with Lemtrada and another DMT.
Consistent with the CARE-MS I and II full cohorts, through year
six the most frequent adverse events (AEs) observed with Lemtrada
were infusion-associated reactions; other AEs of interest included
autoimmune AEs.
“Relapses are not uncommon following the initiation of
disease-modifying therapies for relapsing MS. Approximately 25% to
45% of RMS patients treated with DMTs experience relapses in the
first year or two of treatment,1,2" said Barry Singer, M.D.,
Director of The MS Center for Innovations in Care, Missouri Baptist
Medical Center, St. Louis, MO. “The new Lemtrada data being
presented at AAN suggest that occurrence of relapses in patients
after receiving their initial course but before receiving their
second course is not an indicator of lack of response to the
treatment, and support the importance of administering the full
two-course regimen. The 24% of Lemtrada-treated patients in CARE-MS
II who relapsed between their first and second courses experienced
a marked improvement in clinical and MRI disease activity at year
2, which was maintained through six years. The results observed in
these patients through six years were similar to those observed in
the 76% of patients who were relapse-free between courses one and
two."
The Phase III trials of Lemtrada were randomized, open-label,
rater-blinded, two-year pivotal studies comparing treatment with
Lemtrada to high-dose subcutaneous interferon beta-1a 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). Active disease was defined as at least two relapses
in the previous two years and at least one in the previous year.
More than 90 percent of the patients who were treated with Lemtrada
in the CARE-MS trials enrolled in the extension study. These
patients were eligible to receive additional treatment with
Lemtrada during the extension if they experienced at least one
relapse or at least two new or enlarging brain or spinal cord
lesions. They were eligible to receive treatment with another DMT
during the extension at the investigator’s discretion.
In clinical trials, serious side effects associated with
Lemtrada included infusion reactions, autoimmune disorders (such as
thyroid disease, autoimmune cytopenias, and nephropathies),
infections and pneumonitis. Lemtrada may cause an increased risk of
malignancies. Risk management programs incorporating education and
monitoring help support early detection and management of key
identified and potential risks. 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. (See Important
Safety Information below.)
About Lemtrada® (alemtuzumab)Lemtrada
is approved in more than 60 countries, with additional marketing
applications under review by regulatory authorities globally.
Lemtrada is supported by a comprehensive and extensive clinical
development program that involved nearly 1,500 patients worldwide
and 5,400 patient-years of follow-up. More than 13,0003 patients
have been treated with Lemtrada commercially worldwide.
The precise mechanism by which alemtuzumab exerts its
therapeutic effects in MS is unknown. 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. Lemtrada depletes 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.
Sanofi 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.
Lemtrada® (alemtuzumab) U.S.
IndicationLEMTRADA is a prescription medicine used to treat
adults with relapsing forms of multiple sclerosis (MS). Because of
its risks, LEMTRADA is generally used in people who have tried 2 or
more MS medicines that have not worked well enough. It is not known
if LEMTRADA is safe and effective for use in children under 17
years of age.
Do not receive LEMTRADA if you are infected with human
immunodeficiency virus (HIV).
IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including:
Serious autoimmune problems: Some people receiving
LEMTRADA develop a condition where the immune cells in your body
attack other cells or organs in the body (autoimmunity), which can
be serious and may cause death. Serious autoimmune problems may
include:
• Immune thrombocytopenia, which is when
reduced platelet counts in your blood cause severe bleeding that,
if not treated, may cause life-threatening problems. Call your
healthcare provider right away if you have any of the following
symptoms: easy bruising; bleeding from a cut that is hard to stop;
heavier menstrual periods than normal; bleeding from your gums or
nose that is new or takes longer than usual to stop; small,
scattered spots on your skin that are red, pink, or purple
• Kidney problems called anti-glomerular
basement membrane disease, which can, if untreated, lead to severe
kidney damage, kidney failure that needs dialysis, a kidney
transplant, or death. Call your healthcare provider right away if
you have any of the following symptoms: blood in the urine (red or
tea-colored urine); swelling of legs or feet; coughing up blood
It is important for you to have blood and urine tests before you
receive, while you are receiving and every month, for 4 years or
longer, after you receive your last LEMTRADA infusion.
Serious infusion reactions: LEMTRADA can cause serious
infusion reactions that may cause death. Serious infusion reactions
may happen while you receive, or up to 24 hours or longer after you
receive LEMTRADA.
• You will receive your infusion at a
healthcare facility with equipment and staff trained to manage
infusion reactions, including serious allergic reactions, and
urgent heart or breathing problems. You will be watched while you
receive, and for 2 hours or longer after you receive, LEMTRADA. If
a serious infusion reaction happens while you are receiving
LEMTRADA, your infusion may be stopped.
Tell your healthcare provider right away if you have any of the
following symptoms of a serious infusion reaction during the
infusion, and after you have left the healthcare facility:
• swelling in your mouth or throat • fast, slow, or
irregular heartbeat • trouble breathing • chest pain • weakness •
rash
To lower your chances of getting a serious infusion reaction,
your healthcare provider will give you a medicine called
corticosteroids before your first 3 infusions of a treatment
course. You may also be given other medicines before or after the
infusion to try to reduce your chances of having these reactions or
to treat them after they happen.
Certain cancers: Receiving LEMTRADA may increase your
chance of getting some kinds of cancers, including thyroid cancer,
skin cancer (melanoma), and blood cancers called
lymphoproliferative disorders and lymphoma. Call your healthcare
provider if you have the following symptoms that may be a sign of
thyroid cancer:
• new lump • trouble swallowing or breathing •
swelling in your neck • cough that is not caused by a cold • pain
in front of neck • hoarseness or other voice changes that do not go
away
Have your skin checked before you start receiving LEMTRADA and
each year while you are receiving treatment to monitor for symptoms
of skin cancer.
Because of risks of autoimmunity, infusion reactions, and
some kinds of cancers, LEMTRADA is only available through a
restricted program called the LEMTRADA Risk Evaluation and
Mitigation Strategy (REMS) Program.
Thyroid problems: Some patients taking LEMTRADA may get
an overactive thyroid (hyperthyroidism) or an underactive thyroid
(hypothyroidism). Call your healthcare provider if you have any of
these symptoms:
• excessive sweating • unexplained weight gain •
unexplained weight loss • feeling cold • eye swelling • worsening
tiredness • nervousness • constipation • fast heartbeat
Low blood counts (cytopenias): LEMTRADA may cause a
decrease in some types of blood cells. Some people with these low
blood counts have increased infections. Call your doctor right away
if you have symptoms of cytopenias such as:
• weakness • dark urine • chest pain • fast heartbeat
• yellowing of the skin or whites of
theeyes (jaundice)
Serious infections: LEMTRADA may cause you to have a
serious infection while you receive and after receiving a course of
treatment. Serious infections may include:
• Herpes viral infections. Some people
taking LEMTRADA have an increased chance of getting herpes viral
infections. Take any medicines as prescribed by your healthcare
provider to reduce your chances of getting these infections.
• Tuberculosis. Your healthcare
provider should check you for tuberculosis before you receive
LEMTRADA.
• Hepatitis. People who are at high
risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV)
may be at risk of irreversible liver damage.
These are not all the possible infections that could happen
while on LEMTRADA. Call your healthcare provider right away if you
have symptoms of a serious infection such as fever or swollen
glands. Talk to your healthcare provider before you get
vaccinations after receiving LEMTRADA. Certain vaccinations may
increase your chances of getting infections.
Swelling of lung tissue (pneumonitis): Some people have
had swelling of the lung tissue while receiving LEMTRADA. Call your
healthcare provider right away if you have the following
symptoms:
• shortness of breath • chest pain or tightness •
cough • coughing up blood • wheezing
Before receiving LEMTRADA, tell your healthcare provider if
you:
• are taking a medicine called Campath® (alemtuzumab)• have
bleeding, thyroid, or kidney problems• have HIV• have a recent
history of infection• have received a live vaccine in the past 6
weeks before receiving LEMTRADA or plan to receive any live
vaccines. Ask your healthcare provider if you are not sure if your
vaccine is a live vaccine• are pregnant or plan to become pregnant.
LEMTRADA may harm your unborn baby. You should use birth control
while receiving LEMTRADA and for 4 months after your course of
treatment• are breastfeeding or plan to breastfeed. You and your
healthcare provider should decide if you should receive LEMTRADA or
breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. LEMTRADA and other medicines may
affect each other, causing side effects. Especially tell your
healthcare provider if you take medicines that increase your chance
of getting infections, including medicines used to treat cancer or
to control your immune system.
The most common side effects of LEMTRADA include:
• rash • trouble sleeping • diarrhea •
headache • upper respiratory infection • sinus infection • thyroid
problems • herpes viral infection • mouth pain or sore throat •
fever • hives • tingling sensation • swelling of your nose and
throat • itching • dizziness • nausea • fungal infection • stomach
pain • urinary tract infection • joint pain • sudden redness in
face, neck, or chest • feeling tired • pain in your arms or legs •
vomiting • back pain
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of LEMTRADA.
You are encouraged to report side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch
or call 1-800-FDA-1088
Please see full U.S. Prescribing Information,
including boxed WARNING and Medication Guide.
About SanofiSanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. Learn more
at www.sanofigenzyme.com.
Sanofi® is a registered trademark of Sanofi. Genzyme® and
Lemtrada® are registered trademarks of Genzyme Corporation. All
rights reserved.
1 Schwid SR, Panitch HS. Clinical Therapeutics 2007;
29:2031-48.
2 PolmanCP, O’Connor PW, Havrdova E, et al. New England Journal
of Medicine 2006; 354:899-910
3 Company data on file
Sanofi Forward-Looking StatementsThis press release
contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words “expects”,
“anticipates”, “believes”, “intends”, “estimates”, “plans” and
similar expressions. Although Sanofi’s management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2016. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
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