Results showed improved or preserved
cognitive function in a majority of people regardless of baseline
values, with the greatest effect observed in almost 80% of people
with high thalamic volume (45.5% improved and 34.1% preserved) at
Month 48 of the DAYBREAK open-label extension trial
Zeposia was well tolerated, with more than
80% of people staying on therapy through 48 months
New analyses to be presented at the 8th
European Academy of Neurology Congress in Vienna, Austria
Bristol Myers Squibb (NYSE:BMY) today announced new post-hoc
analyses from the Zeposia (ozanimod) Phase 3 DAYBREAK open-label
extension (OLE) and Phase 3 SUNBEAM trials, showing early Zeposia
use demonstrated cognitive benefits in people with relapsing
multiple sclerosis (MS), with the greatest effect seen in people
with high thalamic volume (TV), supporting an association between
preserved brain volume (BV) and improved long-term cognitive
outcomes. These data (Presentation #EPO-127) are being presented at
the European Academy of Neurology (EAN) Congress taking place in
Vienna, Austria, from June 25-28.
“Multiple sclerosis can lead to significant, irreversible brain
volume loss and decreased cognition if not treated quickly upon
diagnosis. These new analyses show the potential of early treatment
with Zeposia to help stabilize and even improve cognition in people
with multiple sclerosis with high brain volume, which is important
for doctors and people with multiple sclerosis,” said John DeLuca,
PhD, senior vice president for research and training, Kessler
Foundation, and professor, Department of Physical Medicine &
Rehabilitation and of Neurology, Rutgers New Jersey Medical
School.
In these new exploratory analyses, Zeposia treatment showed
improved or preserved cognitive function in a majority of patients,
with the greatest improvement seen when used early in the disease
when TV remains high, supporting a positive association between
preserved BV and long-term cognitive performance. Zeposia was well
tolerated with more than 80% of people who started the Phase 3
SUNBEAM trial (N=399 at baseline) remaining on continuous therapy
through 48 months of the Phase 3 DAYBREAK OLE study (N=326).
Findings from the new research showed that people with high
versus low BV, particularly TV, had higher cognitive performance,
as assessed by the symbol digit modalities test (SDMT) score, at
baseline. This trend remained stable or improved over 4-5 years of
Zeposia treatment, leading to improved or preserved cognitive
function in almost 80% of people with high TV (SDMT improved:
45.1%; SDMT preserved: 34.4%) and approximately 66% of people with
low BV (SDMT improved: 35.6%; SDMT preserved: 30.7%) at Month 48 of
the Phase 3 DAYBREAK OLE study.
“At Bristol Myers Squibb, we’re committed to pathbreaking
science in multiple immune-mediated diseases with the goal of
alleviating the symptoms and disease progression experienced by
individuals suffering from these illnesses and, ultimately,
elevating the standard of care,” said Jonathan Sadeh, MD, MSc,
senior vice president of Immunology and Fibrosis Development,
Bristol Myers Squibb. “We’re excited by the potential effect of
Zeposia in protecting cognitive function when used early in
treatment before brain volume is lost and what it can mean for
individuals with relapsing multiple sclerosis.”
Bristol Myers Squibb thanks the patients and investigators
involved in the Phase 3 DAYBREAK OLE and Phase 3 SUNBEAM clinical
trials.
About DAYBREAK
DAYBREAK is a Phase 3, multicenter, long-term open-label
extension (OLE), randomized, double-blind, double-dummy,
active-controlled, parallel group study to evaluate the safety and
efficacy of Zeposia (ozanimod) administered orally to patients with
relapsing forms of multiple sclerosis (MS).
Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001
trials diagnosed with relapsing forms of MS are enrolled to receive
treatment until the end of the DAYBREAK trial or until the
development program is discontinued. Patients in the trial are
receiving Zeposia 0.92 mg (equivalent to ozanimod HCl 1 mg). In
total, 2,639 participants completed the parent clinical trials, and
this interim analysis (data cutoff February 2021) includes a total
of 2,494 participants with mean (range) Zeposia exposure of 46.8
(0.03-62.7) months in the OLE study.
About SUNBEAM
SUNBEAM was a pivotal, Phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of two doses of oral Zeposia
(0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCl,
respectively) against weekly intramuscular AVONEX® (interferon
beta-1a) for at least a 12-month treatment period. The study
included 1,346 people living with relapsing forms of multiple
sclerosis (RMS) across 152 sites in 20 countries.
The primary endpoint of the trial was annualized relapse rates
during the treatment period. The secondary MRI endpoints included
the number of new or enlarging hyperintense T2-weighted brain MRI
lesions over 12 months, number of gadolinium-enhanced brain MRI
lesions at Month 12 and percent change from baseline in whole brain
volume at Month 12. Cortical grey and thalamic volume changes were
also prospectively assessed versus active comparator.
An analysis of the time to onset of three-month confirmed
disability progression was prespecified using pooled data from both
the SUNBEAM and RADIANCE Part B Phase 3 trials.
About Multiple Sclerosis
Multiple sclerosis (MS) is a disabling, unpredictable disease in
which the immune system attacks the protective myelin sheath that
covers the nerves. The myelin damage disrupts communication between
the brain and the rest of the body. Ultimately, the nerves
themselves may deteriorate—a process that's currently irreversible.
MS affects 700,000 people in Europe and approximately 2.5 million
people worldwide.
Relapsing forms of MS, including clinically isolated syndrome,
relapsing remitting disease and active secondary progressive
disease, are characterized by clearly defined attacks of worsening
neurologic function. These attacks—often called relapses, flare-ups
or exacerbations—are followed by partial or complete recovery
periods. During these recovery periods, also called remissions,
symptoms improve partially or completely with no apparent
progression of disease. Since MS relapses are unpredictable,
patients can feel frustrated, stressed or scared when they occur.
Relapsing forms of MS are the most common disease course at the
time of diagnosis. Approximately 85% of patients are initially
diagnosed with relapsing forms of MS, compared with 10%-15% with
progressive forms of the disease.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P)
receptor modulator that binds with high affinity to S1P receptors 1
and 5. Zeposia blocks the capacity of lymphocytes to egress from
lymph nodes, reducing the number of lymphocytes in peripheral
blood. The mechanism by which Zeposia exerts therapeutic effects in
multiple sclerosis (MS) is unknown but may involve the reduction of
lymphocyte migration into the central nervous system.
The European Commission approved Zeposia for the treatment of
adult patients with relapsing remitting multiple sclerosis (RRMS)
with active disease as defined by clinical or imaging features in
May 2020 and for the treatment of adults with moderately to
severely active ulcerative colitis (UC) who have had an inadequate
response, lost response, or were intolerant to either conventional
therapy or a biologic agent in November 2021. The U.S. Food and
Drug Administration (FDA) approved Zeposia for the treatment of
adults with relapsing forms of MS in March 2020 and for adults with
moderately to severely active UC on May 27, 2021.
U.S. FDA-APPROVED INDICATIONS FOR ZEPOSIA
ZEPOSIA (ozanimod) is indicated for the treatment of:
1. Relapsing forms of multiple sclerosis (MS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, in adults.
2. Moderately to severely active ulcerative colitis (UC) in
adults.
IMPORTANT SAFETY INFORMATION
Contraindications:
- Patients who in the last 6 months, experienced myocardial
infarction, unstable angina, stroke, transient ischemic attack
(TIA), decompensated heart failure requiring hospitalization, or
Class III/IV heart failure or have the presence of Mobitz type II
second-degree or third degree atrioventricular (AV) block, sick
sinus syndrome, or sino-atrial block, unless the patient has a
functioning pacemaker
- Patients with severe untreated sleep apnea
- Patients taking a monoamine oxidase (MAO) inhibitor
Infections: ZEPOSIA may increase the susceptibility to
infections. Life-threatening and rare fatal infections have
occurred in patients receiving ZEPOSIA. Obtain a recent (i.e.,
within 6 months or after discontinuation of prior MS or UC therapy)
complete blood count (CBC) including lymphocyte count before
initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with
an active infection until the infection is resolved. Consider
interruption of treatment with ZEPOSIA if a patient develops a
serious infection. Continue monitoring for infections up to 3
months after discontinuing ZEPOSIA
- Herpes zoster was reported as an adverse reaction in
ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella
zoster meningitis have been reported with sphingosine 1-phosphate
(S1P) receptor modulators. Patients without a healthcare
professional-confirmed history of varicella (chickenpox), or
without documentation of a full course of vaccination against
varicella zoster virus (VZV), should be tested for antibodies to
VZV before initiating ZEPOSIA. A full course of vaccination for
antibody-negative patients with varicella vaccine is recommended
prior to commencing treatment with ZEPOSIA
- Cases of fatal cryptococcal meningitis (CM) were reported in
patients treated with another S1P receptor modulator. If CM is
suspected, ZEPOSIA should be suspended until cryptococcal infection
has been excluded. If CM is diagnosed, appropriate treatment should
be initiated
- Progressive Multifocal Leukoencephalopathy (PML) is an
opportunistic viral infection of the brain that typically occurs in
patients who are immunocompromised, and that usually leads to death
or severe disability. PML has been reported in patients treated
with S1P receptor modulators and other MS and UC therapies and has
been associated with some risk factors. If PML is suspected,
withhold ZEPOSIA and perform an appropriate diagnostic evaluation.
If confirmed, treatment with ZEPOSIA should be discontinued
- In the MS and UC clinical studies, patients who received
ZEPOSIA were not to receive concomitant treatment with
antineoplastic, non-corticosteroid immunosuppressive, or
immune-modulating therapies used for treatment of MS and UC.
Concomitant use of ZEPOSIA with any of these therapies would be
expected to increase the risk of immunosuppression. When switching
to ZEPOSIA from immunosuppressive medications, consider the
duration of their effects and their mode of action to avoid
unintended additive immunosuppressive effects
- Use of live attenuated vaccines should be avoided during and
for 3 months after treatment with ZEPOSIA. If live attenuated
vaccine immunizations are required, administer at least 1 month
prior to initiation of ZEPOSIA
Bradyarrhythmia and Atrioventricular Conduction Delays:
Since initiation of ZEPOSIA may result in a transient decrease in
heart rate and atrioventricular conduction delays, dose titration
is recommended to help reduce cardiac effects. Initiation of
ZEPOSIA without dose escalation may result in greater decreases in
heart rate. If treatment with ZEPOSIA is considered, advice from a
cardiologist should be sought for those individuals:
- with significant QT prolongation
- with arrhythmias requiring treatment with Class 1a or III
anti-arrhythmic drugs
- with ischemic heart disease, heart failure, history of cardiac
arrest or myocardial infarction, cerebrovascular disease, and
uncontrolled hypertension
- with a history of Mobitz type II second-degree or higher AV
block, sick sinus syndrome, or sino-atrial heart block
Liver Injury: Elevations of aminotransferases may occur
in patients receiving ZEPOSIA. Obtain liver function tests, if not
recently available (i.e., within 6 months), before initiation of
ZEPOSIA. Patients who develop symptoms suggestive of hepatic
dysfunction should have hepatic enzymes checked and ZEPOSIA should
be discontinued if significant liver injury is confirmed. Caution
should be exercised when using ZEPOSIA in patients with history of
significant liver disease
Fetal Risk: There are no adequate and well-controlled
studies in pregnant women. Based on animal studies, ZEPOSIA may
cause fetal harm. Women of childbearing potential should use
effective contraception to avoid pregnancy during treatment and for
3 months after stopping ZEPOSIA
Increased Blood Pressure: Increase in systolic pressure
was observed after about 3 months of treatment and persisted
throughout treatment. Blood pressure should be monitored during
treatment and managed appropriately. Certain foods that may contain
very high amounts of tyramine could cause severe hypertension in
patients taking ZEPOSIA. Patients should be advised to avoid foods
containing a very large amount of tyramine while taking ZEPOSIA
Respiratory Effects: ZEPOSIA may cause a decline in
pulmonary function. Spirometric evaluation of respiratory function
should be performed during therapy, if clinically indicated
Macular edema: S1P modulators have been associated with
an increased risk of macular edema. Patients with a history of
uveitis or diabetes mellitus are at increased risk. Patients with a
history of these conditions should have an ophthalmic evaluation of
the fundus, including the macula, prior to treatment initiation and
regular follow-up examinations. An ophthalmic evaluation is
recommended in all patients at any time if there is a change in
vision. Continued use of ZEPOSIA in patients with macular edema has
not been evaluated; potential benefits and risks for the individual
patient should be considered if deciding whether ZEPOSIA should be
discontinued
Posterior Reversible Encephalopathy Syndrome (PRES): Rare
cases of PRES have been reported in patients receiving a S1P
receptor modulator. If a ZEPOSIA-treated patient develops
unexpected neurological or psychiatric symptoms or any symptom/sign
suggestive of an increase in intracranial pressure, a complete
physical and neurological examination should be conducted. Symptoms
of PRES are usually reversible but may evolve into ischemic stroke
or cerebral hemorrhage. Delay in diagnosis and treatment may lead
to permanent neurological sequelae. If PRES is suspected, treatment
with ZEPOSIA should be discontinued
Unintended Additive Immunosuppressive Effects From Prior
Immunosuppressive or Immune-Modulating Drugs: When switching
from drugs with prolonged immune effects, the half-life and mode of
action of these drugs must be considered to avoid unintended
additive immunosuppressive effects while at the same time
minimizing risk of disease reactivation. Initiating treatment with
ZEPOSIA after treatment with alemtuzumab is not recommended
Severe Increase in Disability After Stopping ZEPOSIA:
Severe exacerbation of disease, including disease rebound, has been
rarely reported after discontinuation of a S1P receptor modulator.
The possibility of severe exacerbation of disease should be
considered after stopping ZEPOSIA treatment so patients should be
monitored upon discontinuation
Immune System Effects After Stopping ZEPOSIA: After
discontinuing ZEPOSIA, the median time for lymphocyte counts to
return to the normal range was 30 days with approximately 90% of
patients in the normal range within 3 months. Use of
immunosuppressants within this period may lead to an additive
effect on the immune system, therefore caution should be applied
when initiating other drugs 4 weeks after the last dose of
ZEPOSIA
Most Common Adverse Reactions that occurred in the MS
clinical trials of ZEPOSIA-treated patients (≥ 4%): upper
respiratory infection, hepatic transaminase elevation, orthostatic
hypotension, urinary tract infection, back pain, and
hypertension
In the UC clinical trials, the most common adverse reactions
that occurred in ≥4% of ZEPOSIA-treated patients and greater than
in patients who received placebo were upper respiratory infection,
liver test increased, and headache
For additional safety information, please see the full
Prescribing Information and Medication
Guide.
Bristol Myers Squibb: Pioneering Paths
Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision –
transforming patients’ lives through science. For people living
with immune-mediated diseases, the debilitating reality of enduring
chronic symptoms and disease progression can take a toll on their
physical, emotional and social well-being, making simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, and our
passion to help patients, the company continues to pursue
pathbreaking science with the goal of delivering meaningful
solutions that address unmet needs in rheumatology,
gastroenterology, dermatology and neurology. We follow the science,
aiming to tailor therapies to individual needs, improve outcomes
and expand treatment options by working to identify mechanisms with
the potential to achieve long-term remission – and perhaps even
cures – in the future. By building partnerships with researchers,
patients and caregivers to deliver innovative treatments, Bristol
Myers Squibb strives to elevate patient care to new standards and
deliver what matters most – the promise of living a better
life.
About Bristol Myers
Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on current expectations and projections about our future
financial results, goals, plans and objectives and involve inherent
risks, assumptions and uncertainties, including internal or
external factors that could delay, divert or change any of them in
the next several years, that are difficult to predict, may be
beyond our control and could cause our future financial results,
goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks,
assumptions, uncertainties and other factors include, among others,
that future study results may not be consistent with the results to
date, that Zeposia (ozanimod) may not receive regulatory approval
for the additional indication described in this release in the
currently anticipated timeline or at all, any marketing approvals,
if granted, may have significant limitations on their use, and, if
approved, whether such product candidate for such additional
indication described in this release will be commercially
successful. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2021, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
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