October 13, 2021: “Bristol Myers Squibb announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).
These data (Presentation #P737) and five additional abstracts from company-sponsored studies will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually October 13-15, 2021.
“Early and effective intervention can significantly impact physical and cognitive results over time, with low relapse rates an important indicator of patient outcomes,” said Bruce Cree, M.D., Ph.D., M.A.S., 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 data from the DAYBREAK trial provide a clear picture of the long-term safety and efficacy profile of Zeposia, and reinforce its potential when used early in the treatment process for people living with relapsing forms of MS.”
In the DAYBREAK extension study, safety was consistent with prior findings and no new safety signals emerged during the reporting period with long-term use of Zeposia. Treatment with Zeposia demonstrated a low annualized relapse rate (ARR) of 0.103.
At months 36 and 48, 75% and 71% of participants were relapse-free and 3- and 6-month confirmed disability progression was observed in 13.9% and 11.4% of participants in the trial, respectively.
“Our presentations at ECTRIMS 2021 bolster the growing body of evidence underscoring the long-term efficacy and safety of Zeposia to treat relapsing forms of MS and demonstrate our focus on delivering meaningful innovations to help preserve the body and mind of people living with MS,” said Jonathan Sadeh, M.D., MSc., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We are committed to advancing our knowledge of this unpredictable, debilitating disease, with the goal of transforming medicine through science.”
In the DAYBREAK trial, of 2,494 participants exposed to Zeposia for an average of 46.8 months, 2,143 participants (85.9%) had any treatment-emergent adverse event (TEAE), 298 (11.9%) had a serious TEAE and 75 (3.0%) discontinued the study due to a TEAE.
The most common TEAEs were nasopharyngitis (19.6%), headache (15.8%), upper respiratory tract infection (11.1%) and lymphopenia (10.3%).
Data from this long-term observational study of patients treated for up to 62.7 months are consistent with the established safety profile of Zeposia and with sustained control of disease activity and disability progression.
At the ECTRIMS 2021 Congress, Bristol Myers Squibb and collaborators will present multiple abstracts that reinforce the company’s growing body of research in MS and commitment to people living with the disease.
Accepted abstracts are available on the ECTRIMS 2021 Congress website.
Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on MS.
Summary of Presentations:
Bristol Myers Squibb studies featured at the ECTRIMS 2021 Congress include:
- Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: interim analysis of the DAYBREAK open-label extension study
Author: Krzysztof W. Selmaj
Presentation Number: P737
Presentation Topic: Long-term treatment monitoring - Hepatic safety of ozanimod in relapsing multiple sclerosis in the DAYBREAK open-label extension study
Author: Krzysztof W. Selmaj
Presentation Number: P725
Presentation Topic: Long-term treatment monitoring - Pharmacovigilance program for ozanimod, a recently approved treatment for relapsing forms of multiple sclerosis
Author: Sonia Afsari
Presentation Number: P156
Presentation Topic: Epidemiology - Effect of ozanimod on circulating leukocyte subtypes in patients with relapsing multiple sclerosis and comparison with healthy volunteers
Author: Sarah Harris
Presentation Number: P659
Presentation Topic: Immunomodulation/immunosuppression - Relationships between on-treatment changes in glial fibrillary acidic protein levels and clinical outcomes in patients with relapsing multiple sclerosis: post hoc analysis of the Phase 3 ozanimod SUNBEAM trial
Author: Sarah Harris
Presentation Number: P570
Presentation Topic: Fluid biomarkers - Treatment patterns in patients with multiple sclerosis: a single hospital cohort study in Sweden
Author: Anna Castelo-Branco
Presentation Number: P905
Presentation Topic: Others
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).
In total, 2,639 participants completed the parent clinical trials, and this interim analysis (data cutoff February 2021), includes a total of 2,494 participants with mean (range) Zeposia exposure of 46.8 (0.03–62.7) months in the OLE.
The primary objective of the trial is to evaluate safety in the overall population. Bristol Myers Squibb thanks the patients and investigators who are participating in this clinical trial.
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.”
