New Long-Term Zeposia (ozanimod) Data Demonstrate Durable Efficacy and Consistent Safety in Relapsing Forms of Multiple Sclerosis
Bristol Myers Squibb (NYSE: BMY) announced new data from the Phase 3 DAYBREAK trial for Zeposia (ozanimod) in treating relapsing forms of multiple sclerosis. The study demonstrated:
1. Sustained decreased rates of brain volume loss for up to 5 years of continuous treatment.
2. Low and stable rates of whole brain volume loss through Month 60.
3. Declining or stable incidence rates of treatment-emergent adverse events over 8+ years.
4. Consistent reductions in brain volume loss when switching from interferon beta-1a to Zeposia.
The data reinforces Zeposia's established safety and efficacy profile as an effective oral therapy for multiple sclerosis, particularly for newly diagnosed patients.
Bristol Myers Squibb (NYSE: BMY) ha annunciato nuovi dati dal trial di Fase 3 DAYBREAK per Zeposia (ozanimod) nel trattamento delle forme recidivanti della sclerosi multipla. Lo studio ha dimostrato:
1. Tassi di perdita di volume cerebrale significativamente ridotti e mantenuti per fino a 5 anni di trattamento continuativo.
2. Tassi di perdita di volume cerebrale totale bassi e stabili fino al mese 60.
3. Tassi di incidenza in declino o stabili di eventi avversi emergenti dal trattamento nell'arco di oltre 8 anni.
4. Riduzioni coerenti nella perdita di volume cerebrale quando si passa da interferone beta-1a a Zeposia.
I dati rafforzano il profilo di sicurezza ed efficacia già stabilito di Zeposia come terapia orale efficace per la sclerosi multipla, in particolare per i pazienti di nuova diagnosi.
Bristol Myers Squibb (NYSE: BMY) anunció nuevos datos del ensayo de Fase 3 DAYBREAK para Zeposia (ozanimod) en el tratamiento de formas recurrentes de esclerosis múltiple. El estudio demostró:
1. Tasas de pérdida de volumen cerebral disminuidas y sostenidas durante hasta 5 años de tratamiento continuo.
2. Tasas bajas y estables de pérdida de volumen cerebral total hasta el mes 60.
3. Tasa de incidencia decreciente o estable de eventos adversos emergentes del tratamiento durante más de 8 años.
4. Reducciones consistentes en la pérdida de volumen cerebral al cambiar de interferón beta-1a a Zeposia.
Los datos refuerzan el perfil de seguridad y eficacia establecido de Zeposia como una terapia oral efectiva para la esclerosis múltiple, especialmente para pacientes recién diagnosticados.
브리스톨 마이어스 스큅 (NYSE: BMY)는 재발형 다발성 경화증 치료를 위한 제포시아 (오자니모드)에 대한 3상 DAYBREAK 시험의 새로운 데이터를 발표했습니다. 이 연구는 다음을 입증했습니다:
1. 최대 5년간 지속적인 치료로 뇌 용적 손실률 감소.
2. 60개월까지 전체 뇌 용적 손실률이 낮고 안정적입니다.
3. 8년 이상에 걸쳐 치료 유발 부작용의 발생률 감소 또는 안정.
4. 인터페론 베타-1a에서 제포시아로 전환할 때 뇌 용적 손실의 일관된 감소.
이 데이터는 새로 진단된 환자들에게 특히 효과적인 경구 요법으로서 제포시아의 안전성 및 유효성 프로필을 강화합니다.
Bristol Myers Squibb (NYSE: BMY) a annoncé de nouvelles données de l'essai de Phase 3 DAYBREAK pour Zeposia (ozanimod) dans le traitement des formes récurrentes de sclérose en plaques. L'étude a démontré :
1. Des taux de perte de volume cérébral réduits et durables pendant jusqu'à 5 ans de traitement continu.
2. Des taux de perte de volume cérébral total bas et stables jusqu'au mois 60.
3. Des taux d'incidence décroissants ou stables des événements indésirables émergents du traitement sur plus de 8 ans.
4. Des réductions cohérentes de la perte de volume cérébral lors du passage de l'interféron bêta-1a à Zeposia.
Les données renforcent le profil de sécurité et d'efficacité établi de Zeposia en tant que thérapie orale efficace pour la sclérose en plaques, en particulier pour les patients récemment diagnostiqués.
Bristol Myers Squibb (NYSE: BMY) gab neue Daten aus der Phase-3-Studie DAYBREAK für Zeposia (Ozanimod) zur Behandlung von rezidivierenden Formen der Multiplen Sklerose bekannt. Die Studie zeigte:
1. Anhaltende Verringerung der Raten des Verlusts des Gehirnvolumens über bis zu 5 Jahre kontinuierlicher Behandlung.
2. Niedrige und stabile Raten des Verlusts des Gesamtgehirnvolumens bis Monat 60.
3. Abnehmende oder stabile Inzidenzraten von behandlungsbedingten Nebenwirkungen über mehr als 8 Jahre.
4. Konsistente Reduktionen des Gehirnvolumens bei einem Wechsel von Interferon Beta-1a zu Zeposia.
Die Daten bekräftigen das etablierte Sicherheits- und Wirksamkeitsprofil von Zeposia als eine effektive orale Therapie für Multiple Sklerose, insbesondere für neu diagnostizierte Patienten.
- Zeposia demonstrated sustained decreased rates of brain volume loss for up to 5 years of continuous treatment
- Low and stable rates of whole brain volume loss through Month 60 (annualized LSM % change: RADIANCE, −0.27; SUNBEAM, −0.35)
- Declining or stable incidence rates of treatment-emergent adverse events over 8+ years of treatment
- Switching from interferon beta-1a to Zeposia consistently reduced rates of whole brain volume loss
- Reversal of cortical grey matter volume loss trend after switching to Zeposia in DAYBREAK trial
- None.
Insights
The long-term DAYBREAK study results for Zeposia (ozanimod) in multiple sclerosis (MS) are highly significant. The data show sustained efficacy in reducing brain volume loss over
A key finding is the reversal of cortical grey matter volume loss after switching to Zeposia, indicating potential neuroprotective effects. This could have substantial implications for long-term cognitive function in MS patients. The safety profile remains consistent over
These results strengthen Zeposia's position in the competitive MS market, particularly for newly diagnosed patients. The data may influence treatment guidelines and increase Zeposia's market share, potentially boosting Bristol Myers Squibb's revenue in this therapeutic area.
This data release is positive for Bristol Myers Squibb (BMY). Long-term efficacy and safety data are important for chronic disease medications like Zeposia. The sustained brain volume preservation and favorable safety profile over
Zeposia, approved in
However, investors should note that Zeposia faces competition from established oral MS therapies. The actual financial impact will depend on how these results translate into prescription patterns and market share gains. Given the positive data, I'd expect a moderate positive impact on BMY's stock in the short term, with potential for long-term growth in the MS segment.
Final results from the DAYBREAK long-term extension study showed brain volume loss decreased during Phase 3 studies and was sustained with continuous Zeposia treatment for up to 5 years
More than eight years of DAYBREAK data confirm established safety profile of Zeposia, with rates of treatment-emergent adverse events declining or stable over time
Additionally, findings from a separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.
These data and 12 additional abstracts will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
“If not treated early upon diagnosis, multiple sclerosis can lead to significant, irreversible brain volume loss and cognitive decline,” said Jeffrey Cohen, MD, Mellen Center for Multiple Sclerosis, Cleveland Clinic,
Reductions in brain volume loss with Zeposia treatment
The DAYBREAK OLE trial included 2,257 patients from the SUNBEAM and RADIANCE Phase 3 trials and evaluated rates of brain volume loss (Poster #P1623). Switching from interferon beta-1a (IFN-β) to Zeposia treatment consistently reduced rates of WBV loss (annualized LSM% change from RADIANCE baseline to Month 24 and DAYBREAK baseline to Month 24: −0.48 and −0.19, respectively, with a similar pattern observed in SUNBEAM). Additionally, similar reductions were observed for change in thalamic volume loss.
High annualized LSM% reductions in cortical grey matter volume (CGMV) were observed with IFN-β (annualized change at Month 12 relative to SUNBEAM baseline: −1.02; annualized change at Month 24 relative to RADIANCE baseline: −0.59), but this trend reversed 12 months after switching to Zeposia in DAYBREAK (annualized LSM% increase relative to DAYBREAK baseline: patients from SUNBEAM, 0.10; patients from RADIANCE, 0.20), with low annualized LSM% CGMV loss observed thereafter.
Established Zeposia safety profile confirmed with more than eight years of DAYBREAK data
The final DAYBREAK OLE safety analysis (Poster #P1609) included 762 patients who were treated with continuous Zeposia with a median exposure of 83.9 months. Incident rates per 1,000 person-years decreased over time from the Phase 3 trials to Month 60 or more of the DAYBREAK OLE trial. Decreases were observed for overall TEAEs (896.1 versus 101.7), infections (300.5 versus 142.6), opportunistic infections (12.0 versus 4.9), cardiac (22.8 versus 9.5), hepatic (77.0 versus 15.7) and pulmonary disorders (11.3 versus 4.7), respectively.
“The data presented at ECTRIMS further reinforce the long-term safety and efficacy of Zeposia and add to the robust body of evidence demonstrating its potential impact on decreasing disease progression over time,” said Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb. “Building on our expertise with Zeposia, we are expanding our pipeline as we continue to look for new ways to advance the field of neuroscience. New modalities and disease targets fuel our goal of delivering medicines that elevate standards of care across neurological diseases, including multiple sclerosis.”
Bristol Myers Squibb thanks the patients and investigators who participated in the 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 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, respectively) against weekly intramuscular Avonex® for at least a 12-month treatment period. The study included 1,346 people living with 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.
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 RMS across 150 sites in 21 countries.
The primary endpoint of the trial was annualized relapse rates over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months.
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
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
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.
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
Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥
In the UC clinical trials, the most common adverse reactions that occurred in ≥
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 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 Zeposia for such 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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FAQ
What were the key findings of the DAYBREAK trial for Zeposia (BMY) in treating multiple sclerosis?
How did Zeposia (BMY) compare to interferon beta-1a in the treatment of multiple sclerosis?
What were the safety findings for Zeposia (BMY) in the DAYBREAK long-term extension study?
When and where will Bristol Myers Squibb (BMY) present the Zeposia data from the DAYBREAK trial?
