Retrospective analyses from the Phase 3
DAYBREAK open-label extension study showed more than 90% of
participants who received Zeposia mounted a serologic
response to COVID-19 vaccination
All adverse events related to COVID-19 in
vaccinated study participants were nonserious
Data are among 13 abstracts being presented
at ECTRIMS 2022 that further reinforce the safety and efficacy
profile of Zeposia and Bristol Myers Squibb’s commitment to
the multiple sclerosis community
Bristol Myers Squibb (NYSE: BMY) today announced new
retrospective analyses on serologic responses and clinical outcomes
with COVID-19 vaccination in participants treated with Zeposia
(ozanimod) from the ongoing Phase 3 DAYBREAK open-label extension
(OLE) study in relapsing multiple sclerosis (MS). More than 92%
(137/148) of all study participants in these analyses mounted a
serological response following vaccination. In addition, among
participants with prior COVID-19 exposure, seroconversion was
observed in 100% (39/39) of individuals following full COVID-19
mRNA or non-mRNA vaccination. COVID-19-related adverse events were
reported in 10% (15/148) of vaccinated participants (12/148
confirmed; 3/148 suspected), all of which were nonserious.
The new analyses (Presentation #P1199) will be featured in the
late-breaking research session on October 27, 2022, at the 38th
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS), taking place in Amsterdam, the
Netherlands.
“These data are of clinical importance for physicians treating
multiple sclerosis, because they provide a greater understanding of
how COVID-19 infections and vaccinations interplay with Zeposia
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. “Regardless of prior COVID-19
exposure, most participants mounted an immune response following
COVID-19 vaccination without experiencing adverse events, in
contrast to some reports of other S1P modulators that described no
response, adding insight to the treatment decision making
process.”
Additional key Bristol Myers Squibb data presentations at
ECTRIMS 2022 include:
- Interim analyses of the ongoing Phase 3 DAYBREAK OLE study
showed that 68% of participants were relapse-free and demonstrated
an adjusted annualized relapse rate (ARR) of 0.099 at up to 74
months of treatment. Findings also showed long-term efficacy was
sustained on MRI measures after 60 months of treatment, with a mean
number of new and enlarging T2 lesions per scan of 0.98, and on
disability progression in up to 74 months of treatment, with a
6-month confirmed disability progression of 14%. Treatment emergent
adverse events (TEAEs) were reported in 88% of participants, with
14% of participants reporting serious TEAEs; 3.6% of participants
discontinued treatment due to TEAEs. (Presentation #P334; Author:
Krzysztof Selmaj)
- Post hoc analyses of the Phase 3 SUNBEAM, RADIANCE and DAYBREAK
OLE studies demonstrated that a greater proportion of patients
treated with Zeposia versus interferon beta-1a had a lower
annualized rate of brain volume loss (SUNBEAM study, Month 12:
50.9% versus 37.5%, respectively; RADIANCE study, Month 24: 63.1%
versus 50%, respectively). In patients continuously treated with
Zeposia, those with low annualized rate of brain volume loss
(ARBVL) showed higher cognitive processing speed as measured by the
mean symbol digits modalities test compared with those with high
ARBVL (SUNBEAM study into OLE study, Month 60: 52.7 versus 45.4;
RADIANCE study into OLE study, Month 72: 50.5 versus 40.5,
respectively). (Author: Bruno Brochet; e-Poster #EP1082)
“We remain dedicated to pursuing pathbreaking science and
collaborating with the scientific and patient communities to deepen
our understanding on the use of our medicines and to help
individuals with multiple sclerosis live healthier, more fulfilling
lives,” said Jonathan Sadeh, MD, MSc, senior vice president of
Immunology and Fibrosis Development, Bristol Myers Squibb. “Our
COVID-19 and disability progression findings, as well as our
presentations demonstrating an association between Zeposia use and
reduced brain volume loss along with improved cognitive processing
speed, reinforce the importance of early intervention in the
treatment of multiple sclerosis and Zeposia’s profile in the
treatment armamentarium.”
Bristol Myers Squibb-sponsored abstracts featured at the
ECTRIMS 2022 Congress:
- Serologic response and clinical outcomes of SARS-CoV-2
infection and vaccination in ozanimod-treated participants with
relapsing multiple sclerosis Author: Bruce Cree Presentation
number: P1199 Session: Poster Session 2
- COVID-19 infections and vaccinations among patients receiving
ozanimod in the DAYBREAK open-label extension trial Author: Bruce
Cree Presentation number: P387 Session: Poster Session 1
- Long-term safety and efficacy of ozanimod in relapsing multiple
sclerosis: Interim analysis of the DAYBREAK open-label extension
study Author: Krzysztof Selmaj Presentation number: P334 Session:
Poster Session 1
- Correlations between early MRI parameters and long-term
clinical outcomes in Phase 3 and open-label extension studies of
ozanimod in relapsing multiple sclerosis Author: Douglas Arnold
Presentation number: P358 Session: Poster Session 1
- Proportion of relapsing MS patients with low vs high annualised
whole brain volume atrophy rates after 5‒6 years of ozanimod and
relationship to cognitive processing speed Author: Bruno Brochet
e-Poster number: EP1082 Session: e-Poster Session
- Impact of ozanimod on absolute lymphocyte count and recovery in
patients with relapsing multiple sclerosis Author: Krzysztof Selmaj
e-Poster number: EP1071 Session: e-Poster Session
- Relationship between infections and absolute lymphocyte count
during Phase 3 and open-label extension trials of ozanimod in
patients with relapsing multiple sclerosis Author: Hans-Peter
Hartung Presentation number: P707 Session: Poster Session 2
- Safety patterns with ozanimod during Phase 3 and open-label
extension trials in patients with relapsing multiple sclerosis
Author: Krzysztof Selmaj Presentation number: P732 Session: Poster
Session 2
- NfL as a predictor of GdE lesions in patients with relapsing
multiple sclerosis treated with ozanimod in the Phase 2 RADIANCE
trial Author: Krzysztof Selmaj e-Poster number: EP1020 Session:
e-Poster Session
- Post hoc analysis of cognitive processing speed at time of
first confirmed relapse in patients with relapsing multiple
sclerosis treated with ozanimod vs interferon β-1A in the Phase 3
SUNBEAM trial Author: John DeLuca e-Poster number: EP1116 Session:
e-Poster Session
- Effect of disease modifying therapy on T2-flair-based
neurodegenerative MRI outcomes: A longitudinal, real-world,
US-based, multi-center multiple sclerosis study Author: Bruce Cree
e-Poster number: EP1121 Session: e-Poster Session
- The impact of cognitive impairment on disease burden in Chinese
patients with multiple sclerosis: A model simulation study Author:
Qian Jiang e-Poster number: EP0870 Session: e-Poster Session
- Uncovering challenges in achieving health equity in multiple
sclerosis care: A deep-dive into the experiences and perspectives
of patients and their care teams in general neurology and MS
specialty clinics Author: Mitzi Williams Presentation number: P110
Session: Poster Session 1
Bristol Myers Squibb thanks the patients and investigators who
are participating in our Zeposia clinical trials.
About DAYBREAK
DAYBREAK is a Phase 3, multi-center, 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).
About RADIANCE
RADIANCE Part B was a pivotal, Phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of oral Zeposia (0.92 mg,
equivalent to 1 mg) against weekly intramuscular AVONEX®
(interferon beta-1a) over a 24-month treatment period. The study
included 1,320 people living with relapsing forms of MS across 150
sites in 21 countries.
The primary endpoint of the trial was ARR over 24 months. The
secondary MRI endpoints included the number of new or enlarging
hyperintense T2-weighted brain MRI lesions over 24 months.
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 MS 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.
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, 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. 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 U.S. Food and Drug Administration approved Zeposia for the
treatment of adults with relapsing forms of multiple sclerosis in
March 2020 and adults with moderately to severely active UC in May
2021. The European Commission approved Zeposia for the treatment of
adult patients with relapsing remitting multiple sclerosis with
active disease as defined by clinical or imaging features in May
2020 and for the treatment of adults with moderately to severely
active UC who have had an inadequate response, lost response, or
were intolerant to either conventional therapy or a biologic agent
in November 2021.
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.
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. 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.
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: Use is
not recommended.
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
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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
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financial results, goals, plans and objectives and involve inherent
risks, assumptions and uncertainties, including internal or
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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 any marketing approvals, if granted, may have
significant limitations on their use, and that such product
candidate for the indication described in this release, may not be
commercially successful. No forward-looking statement can be
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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
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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
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