Bristol Myers Squibb Gets Positive Phase 3 Trial Results for Zeposia

Bristol Myers Squibb Gets Positive Phase 3 Trial Results for Zeposia

By, Admin 4 March 2024

Bristol Myers Squibb announces positive results from phase 3 DAYBREAK open-label extension trial of Zeposia in patients with relapsing forms of MS

Bristol Myers Squibb 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.

DAYBREAK Study for Zeposia

  • 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.

Words from Investigator

“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.”

DAYBREAK Trial Data

  • 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.

Separate Analysis

  • 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.

Words from Leadership

“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.”

Presentation in ACTRIMS Forum 2024

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.

About Trial

  • Bristol Myers Squibb thanks the patients and investigators who have participated in Zeposia clinical trials.
  • 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 Multiple Sclerosis

  • 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

  • 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.

About Company

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

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