Zeposia maintains disease control even in the
event of temporary treatment interruption for up to eight weeks
Zeposia is the first oral sphingosine
1-phosphate (S1P) receptor modulator approved to treat patients
with ulcerative colitis
Bristol Myers Squibb (NYSE: BMY) today announced new post hoc
analyses from the Phase 3 True North study evaluating the duration
of response following continuous Zeposia (ozanimod) treatment for
up to one year and following treatment interruption in patients
with moderately to severely active ulcerative colitis (UC). After
achieving a clinical response at the end of the induction period,
86.1% of patients who remained on Zeposia showed no disease relapse
at Week 52 (Kaplan-Meier [KM] estimates of no disease relapse at
Week 52: Zeposia/Zeposia, 86.1%; Zeposia/placebo, 62.6%).
As temporary treatment discontinuation may occur in clinical
practice, these analyses evaluated the duration of response
following treatment interruption. Findings showed that Zeposia
maintained disease control for up to eight weeks in patients who
switched to placebo after initial response (KM estimates of no
disease relapse at Week 8: Zeposia/Zeposia, 96.1%; Zeposia/placebo,
90.6%). These analyses (Presentation #62) and 10 additional Zeposia
abstracts demonstrating Bristol Myers Squibb’s robust body of
research in gastroenterology are being presented at the American
College of Gastroenterology (ACG) annual scientific meeting, taking
place October 21 – 26, 2022.
"Understanding the duration of response after continuous
ozanimod treatment is critical, as it can assist in clinical
decision making when considering temporary discontinuation of UC
treatment in clinical practice," said Bruce E. Sands, MD, MS,
Gastroenterologist and paid consultant of Bristol Myers Squibb. Dr.
Sands is also the Dr. Burrill B. Crohn Professor of Medicine
(Gastroenterology) at the Icahn School of Medicine at Mount Sinai
and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology
at Mount Sinai Health System. "These analyses reaffirm that
ozanimod treatment is effective at helping patients remain
relapse-free and suggest that a majority of patients remain
relapse-free for up to eight weeks after treatment is
interrupted.”
"These data presented at ACG demonstrate Zeposia treatment
prevents disease relapse over one year of continuous treatment and
maintains disease control even in the event of temporary
interruption,” said Jonathan Sadeh, MD, MSc, senior vice president
of Immunology and Fibrosis Development, Bristol Myers Squibb.
“These analyses reinforce the established profile of Zeposia for
people living with moderately to severely active UC and underscore
our long-standing commitment to the gastroenterology
community.”
Additional analyses presented demonstrate no additional safety
signals were observed after approximately two years of continuous
Zeposia treatment.
Bristol Myers Squibb thanks the patients and investigators
involved in the True North study.
Bristol Myers Squibb-sponsored abstracts featured at the ACG
2022 Scientific Meeting include:
- Duration of response to ozanimod after treatment withdrawal:
Results from the Phase 3 True North study Author: Bruce E. Sands
Presentation Number: 62 Plenary Session 4A – Colon/IBD
- Efficacy and safety of 2 years of continuous ozanimod
treatment: Interim analysis of the True North open-label extension
study Author: Maria T. Abreu Presentation Number: D0406 Poster
- Humoral immune responses to SARS-CoV-2 vaccines in an ozanimod
open-label extension study Author: Freddy Caldera Presentation
Number: E0367 Poster
- Efficacy of ozanimod in vedolizumab-exposed patients with
ulcerative colitis: A Phase 3 True North post hoc analysis Author:
Bruce E. Sands Presentation Number: B0352 Poster
Zeposia Clinical Encore Presentations
- Ozanimod is an effective oral treatment for patients with
ulcerative colitis regardless of moderate or severe endoscopic
disease activity at baseline: A post hoc analysis of the Phase 3
True North study Author: Douglas C. Wolf Presentation Number: C0387
Poster
- Ozanimod is an effective oral treatment for patients with
ulcerative colitis regardless of baseline endoscopic disease
distribution: A post hoc analysis of the Phase 3 True North study
Author: Anita Afzali Presentation Number: E0343 Poster
- Evaluation of ozanimod efficacy and safety in older patients
with ulcerative colitis: Post hoc analysis from the Phase 3 True
North study Author: Nabeel Khan Presentation Number: A0391
Poster
- Hepatic safety of ozanimod in ulcerative colitis and relapsing
multiple sclerosis Phase 3 trials Author: David T. Rubin
Presentation Number: B0368 Poster
- Ozanimod is an efficacious oral therapy after 5-ASA failure in
immunomodulator- and biologic-naive patients with ulcerative
colitis: Post hoc analysis from True North Author: Bruce E. Sands
Presentation Number: A0392 Poster
- Association between absolute lymphocyte count and ozanimod
efficacy/safety in patients with moderate/severe ulcerative
colitis: Results from the Phase 3 True North study Author: Sarah
Harris Presentation Number: E0354 Poster
- Impact of ozanimod on fecal calprotectin levels and the
association with efficacy in patients with moderately to severely
active ulcerative colitis: Results from the Phase 3 True North
study Author: Sarah Harris Presentation Number: E0355 Poster
About True North
True North is a Phase 3, multicenter, randomized, double-blind,
placebo-controlled clinical trial assessing the efficacy and safety
of Zeposia 0.92 mg in patients with moderately to severely active
ulcerative colitis (UC) who had an inadequate response or were
intolerant to any of the following: oral aminosalicylates,
corticosteroids, immunomodulators or a biologic. Patients were to
be receiving treatment with oral aminosalicylates and/or
corticosteroids prior to and during the induction period. A total
of 30% of patients had previously failed or were intolerant to
tumor necrosis factor (TNF) blockers. Of these patients, 63%
received at least two biologics including TNF blockers. At study
entry, mean age was 42 years, 60% were male and mean disease
duration was 7 years; patient characteristics were well balanced
across treatment groups. In the 10-week induction study (UC Study
1), a total of 645 patients were randomized 2:1 to receive Zeposia
(n=429) or placebo (n=216), of whom 94% and 89%, respectively,
completed the induction study. No new safety signals were observed
in the induction phase.
In the maintenance study (UC Study 2) a total of 457 patients
who received Zeposia in either UC Study 1 or in an open-label arm
and achieved clinical response at Week 10 were re-randomized 1:1
and were treated with either Zeposia 0.92 mg (n=230) or placebo
(n=227) for 42 weeks, for a total of 52 weeks of treatment.
Concomitant aminosalicylates were required to remain stable through
Week 52. Patients on concomitant corticosteroids were to taper
their dose upon entering the maintenance study. Of these, 80% and
54.6% of patients who received Zeposia and placebo, respectively,
completed the study. In the maintenance phase, the overall safety
profile was consistent with the known safety profile for Zeposia
and patients with moderate to severe UC. More information about the
True North trial can be found on www.clinicaltrials.gov,
NCT02435992.
For the True North open-label extension (OLE) study, eligible
patients who completed the maintenance UC Study 2 were rolled into
the OLE study, which is ongoing and designed to assess the
longer-term profile of Zeposia for the treatment of moderately to
severely active UC. Patients were also eligible to enter the OLE
study if they completed UC Study 1 and did not achieve a clinical
response or if they experienced a disease relapse during UC Study
2. Among patients who entered the trial, clinical remission,
clinical response, endoscopic improvement and symptomatic remission
were generally maintained through Week 142. No new safety concerns
were identified in this study extension in patients with ulcerative
colitis. More information about the open-label extension trial can
be found on https://www.clinicaltrials.gov/, NCT02531126.
About Ulcerative Colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD),
is characterized by an irregular, chronic immune response that
creates inflammation and ulcers (sores) in the mucosa (lining) of
the large intestine (colon) or rectum. Symptoms include bloody
stools, severe diarrhea and frequent abdominal pain. Ulcerative
colitis has a major impact on patients' health-related quality of
life, including physical functioning, social and emotional
well-being and ability to go to work/school. Many patients have an
inadequate response or do not respond at all to currently available
therapies. It is estimated that approximately 12.6 million people
worldwide are living with IBD.
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 reduces the capacity of lymphocytes to migrate from
lymphoid tissue, reducing the number of circulating lymphocytes in
peripheral blood. The mechanism by which Zeposia exerts therapeutic
effects in ulcerative colitis (UC) is unknown but may involve the
reduction of lymphocyte migration into the intestines.
Bristol Myers Squibb is continuing to evaluate Zeposia in the
ongoing True North open-label extension trial, designed to assess
the longer-term profile of Zeposia for the treatment of moderately
to severely active UC. The company is also investigating Zeposia
for the treatment of moderately to severely active Crohn’s disease
in the ongoing Phase 3 YELLOWSTONE clinical trial program.
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:
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 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
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 post-marketing studies may not be consistent with the
results of this study, that Zeposia, for the indication described
in this release, may not be commercially successful, that any
marketing approvals, if granted, may have significant limitations
on their use, and that continued approval of such product candidate
for such indication described in this release 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, 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.
corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221021005498/en/
Bristol Myers Squibb Media Inquiries:
media@bms.com Investors: Tim Power 609-252-7509
timothy.power@bms.com Nina Goworek 908-673-9711
nina.goworek@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2023 to Apr 2024