Sustained efficacy was confirmed with an
annualized relapse rate of 0.098 and 67% of patients were
relapse-free at six years
Safety was consistent with prior findings and
the established safety profile of Zeposia with nearly 10 years of
clinical experience
In a separate DAYBREAK analysis, nearly 97% of
followed patients were relapse-free at 90 days post Zeposia
discontinuation; patients that did relapse showed no evidence of
rebound effect
Bristol Myers Squibb (NYSE: BMY) today announced new results
from the Phase 3 DAYBREAK open-label extension trial, demonstrating
the long-term efficacy and safety profile of Zeposia (ozanimod) in
patients with relapsing forms of multiple sclerosis (MS). These
data (Poster #P090) and nine additional abstracts will be presented
at the 9th annual Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) Forum 2024 in West Palm Beach, Florida
taking place February 29 to March 2.
In the DAYBREAK long-term extension study, treatment with
Zeposia demonstrated a low annualized relapse rate of 0.098. Three-
and six-month confirmed disability progression was absent in 82.8%
and 84.8% of participants in the trial respectively. At Month 60,
the adjusted mean number of new/enlarging T2 lesions per scan
(range: 0.79–0.93) and the adjusted mean number of
gadolinium-enhancing lesions (0.06–0.08) were similar across
patient cohorts.
“These DAYBREAK data continue to validate the role of Zeposia in
the long-term management of relapsing forms of multiple sclerosis,
with two-thirds of patients relapse-free at six years of
treatment,” said Bruce Cree, MD, PhD, MAS, study investigator and
professor of Clinical Neurology, University of California San
Francisco (UCSF) Weill Institute for Neurosciences and Clinical
Research Director, UCSF MS Center. “These findings add to our
confidence in Zeposia as an important treatment option for people
living with the disease, highlighting its efficacy and safety over
time.”
In the DAYBREAK trial, 2,494 participants were exposed to
Zeposia for an average of 60.9 months (12,664.7 person-years);
2,219 participants (89.0%) had any treatment-emergent adverse event
(TEAE), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued
the study due to a TEAE. The most common TEAEs were nasopharyngitis
(21.3%), headache (17.1%), COVID-19 infection (16.5%) and upper
respiratory tract infection (12.4%). No new safety signals emerged;
data from this long-term observational study of patients treated
for up to 81.5 months were consistent with the established safety
profile of Zeposia.
Additionally, a separate analysis (Poster #P097) was conducted
to assess the risk of rebound after Zeposia discontinuation in the
DAYBREAK trial. Five hundred forty-four participants (21.8%)
discontinued the study early, while 1,950 participants (78.2%)
remained on treatment until the end of the trial. Approximately
2.2% were known to have relapsed after permanently discontinuing
Zeposia, with 87.3% of relapses occurring between 29 and 90 days
(median time to onset: 61 days) after discontinuation. Nearly all
patients were not taking any disease modifying therapy for MS at
the time of relapse. Most relapses were mild (n=20 [36.4%]) or
moderate (n=34 [61.8%]) and most patients made a complete recovery.
No post-treatment relapse was associated with rebound effect,
characterized by severe exacerbation of disease or severe
persistent increase in disability.
“Currently no cure exists for multiple sclerosis, but effective
strategies and treatments can help slow disease progression and
alleviate symptoms,” said Jonathan Sadeh, MD, MSc, senior vice
president and head of global program leaders, Immunology,
Cardiovascular and Neuroscience development, Bristol Myers Squibb.
“These DAYBREAK efficacy, safety and rebound data underscore a
consistent and sustained safety and efficacy profile and add to the
body of evidence supporting Zeposia’s role in the treatment
armamentarium. We remain focused on advancing care and delivering
meaningful innovations in neuroscience, including for the millions
of people impacted by relapsing forms of multiple sclerosis.”
At the ACTRIMS Forum 2024, Bristol Myers Squibb and
collaborators will present multiple abstracts that reinforce the
company’s growing body of research on Zeposia as a treatment for
relapsing forms of MS and unwavering commitment to people living
with the disease.
Summary of Presentations:
Bristol Myers Squibb presentations featured at the ACTRIMS Forum
2024 include:
Zeposia clinical abstracts
- Long-term safety and efficacy of ozanimod in relapsing multiple
sclerosis: Final analysis of the DAYBREAK open-label extension
study Author: Krzysztof Selmaj Presentation Number: P090 Session
Number: Poster session 1
- Absence of rebound effect following ozanimod discontinuation
among participants in the DAYBREAK open-label extension study
Author: Ralf Gold Presentation Number: P097 Session: Poster session
1
- Patient-reported outcomes after 1 year of ozanimod use for
early relapsing multiple sclerosis: An interim analysis of the
ENLIGHTEN study Author: Sarah Morrow Presentation Number: P433
Session: Poster session 2
- Baseline predictors of long-term disability progression in
ozanimod-treated participants with relapsing multiple sclerosis
from the SUNBEAM, RADIANCE, and DAYBREAK trials Author: Hans-Peter
Hartung Presentation Number: P096 Session: Poster session 1
- Changes in cognitive functioning over 1 year in
ozanimod-treated patients with early relapsing multiple sclerosis:
An interim analysis of the ENLIGHTEN study Author: John DeLuca
Presentation Number: P354 Session: Poster session 2
- Long-term efficacy of ozanimod in disease-modifying
treatment–naive vs experienced patients with relapsing multiple
sclerosis Author: Diego Centonze Presentation Number: P092 Session:
Poster session 1
- Long-term efficacy of the sphingosine 1-phosphate receptor
modulator ozanimod by age category in patients with relapsing
multiple sclerosis: Final results from two Phase 3 trials and an
open-label extension trial Author: Bruce Cree Presentation Number:
P091 Session: Poster session 1
- Effects of ozanimod on cognitive processing speed: Updated
findings from the Phase 3 SUNBEAM and DAYBREAK extension trials
Author: John DeLuca Presentation Number: P353 Session: Poster
session 2
Zeposia MS health economics outcomes research
abstracts
- Real-world clinical outcomes for disease-modifying
therapy–naïve and experienced patients with multiple sclerosis
treated with ozanimod: A U.S. retrospective medical chart review
Author: Damemarie Paul Presentation Number: P477 Session: Poster
session 2
- Ozanimod use in patients with multiple sclerosis treated in a
large U.S. healthcare system: A retrospective case series Author:
Jennifer Hadlock Presentation Number: P478 Session: Poster session
2
Bristol Myers Squibb thanks the patients and investigators who
have participated in Zeposia clinical trials.
About DAYBREAK
DAYBREAK was a Phase 3, multi-center, long-term open-label
extension study to evaluate the safety and efficacy of Zeposia
(ozanimod) administered orally to patients with relapsing forms of
multiple sclerosis (RMS).
Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001
trials diagnosed with RMS were enrolled to receive treatment until
the end of the DAYBREAK. Patients in the trial received Zeposia
0.92 mg (equivalent to 1 mg).
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 2.9 million
people worldwide.
Relapsing forms of MS (RMS), including clinically isolated
syndrome, relapsing remitting disease and active secondary
progressive disease, is 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. However, smoldering
neuroinflammation can be present from the earliest stages of MS,
which is underlying and continuous disease activity occurring
simultaneously in different areas of the brain that contributes to
disability accumulation. Since MS relapses are unpredictable,
patients can feel frustrated, stressed or scared when they occur.
RMS is the most common disease course at the time of diagnosis.
Approximately 85% of patients are initially diagnosed with RMS,
compared with 10%-15% diagnosed with progressive forms of the
disease.
Bristol Myers Squibb: Delivering Breakthrough Science for
Meaningful Interventions in Neuroscience
Neurological conditions represent some of the greatest
challenges of our time because of their impact on society,
including patients, caregivers, families and healthcare systems. At
Bristol Myers Squibb, we are committed to advancing our robust
pipeline of potential medicines for neurological disorders with the
goal of modifying disease and improving quality of life. Leveraging
genetics, biomarkers and predictive sciences, we target key
pathways involved in the initiation and progression of neurological
diseases to develop therapies with the potential to optimize
patient outcomes.
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.
Zeposia is approved in numerous countries around the world for
the treatment of adults with relapsing forms of MS and adults with
moderately to severely active ulcerative colitis.
U.S. FDA APPROVED INDICATIONS
ZEPOSIA® (ozanimod) is indicated for the treatment of:
- Relapsing forms of multiple sclerosis (MS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, in adults.
- 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 a 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.
- 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.
Progressive Multifocal Leukoencephalopathy (PML): 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, including ZEPOSIA, 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.
Immune reconstitution inflammatory syndrome (IRIS) has been
reported in MS patients treated with S1P receptor modulators who
developed PML and subsequently discontinued treatment. IRIS
presents as a clinical decline in the patient’s condition that may
be rapid, can lead to serious neurological complications or death,
and is often associated with characteristic changes on MRI. The
time to onset of IRIS in patients with PML was generally within a
few months after S1P receptor modulator discontinuation. Monitoring
for development of IRIS and appropriate treatment of the associated
inflammation should be undertaken.
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.
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. Women who become pregnant while
taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry
by calling 1-877-301-9314 or visiting
www.zeposiapregnancyregistry.com.
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 Multiple Sclerosis (MS) Disability After
Stopping ZEPOSIA: In MS, 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. After stopping ZEPOSIA in the setting of PML,
monitor for development of immune reconstitution inflammatory
syndrome (PML-IRIS).
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.
Use in Specific Populations: Hepatic Impairment: Dosage
adjustment in patients with mild or moderate hepatic impairment
(Child-Pugh class A or B) is required, and use of ZEPOSIA in
patients with severe hepatic impairment (Child-Pugh class C) is not
recommended.
For additional safety information, please see the full
Prescribing Information and Medication
Guide.
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 results of future post-marketing studies will be consistent
with the results of this study, that Zeposia (ozanimod) for the
additional indication described in this release may not be
commercially successful, any marketing approvals, if granted, may
have significant limitations on their use, and that continued
approval of such treatment for such additional indication may be
contingent upon verification and description of clinical benefit in
additional confirmatory trials. 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, 2023, 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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