Zeposia (ozanimod) oral capsules continue to safely and effectively prevent relapses and disability progression in people with relapsing forms of multiple sclerosis (MS), according to three-year data from a Phase 3 extension clinical trial.
“Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients,” Bruce Cree, MD, PhD, said in a press release. Cree is the trial’s investigator and clinical research director at University of California San Francisco (UCSF) MS Center,
“The DAYBREAK trial provides us with important context regarding the longer-term efficacy and safety profile of Zeposia,” added Cree, who also is a professor of clinical neurology at UCSF Weill Institute for Neurosciences.
The findings will be presented in a poster titled “Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1−3 trials,” (abstract #P0217) at the MSVirtual2020 meeting set for Sept. 11–13.
The MSVirtual2020 is a joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) online conference.
Zeposia is a sphingosine-1-phosphate (S1P) receptor modulator developed by Celgene, a subsidiary of Bristol Myers Squibb. It works by preventing immune cells from leaving the lymph nodes, entering circulation, and reaching the brain and spinal cord, where they can promote further inflammation and nerve cell damage.
It is approved in the U.S. for the treatment of relapsing forms of MS — including relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome — and in the European Union for active RRMS.
Both approvals were based on positive data from the global Phase 3 SUNBEAM (NCT02294058) and RADIANCE part B (NCT02047734) clinical trials. Results showed that Zeposia was superior to Avonex in lowering annualized relapse rates (ARR) — the number of relapses per year — and brain lesions for up to two years in people with RRMS or active SPMS.
The ongoing Phase 3 DAYBREAK extension study (NCT02576717) is evaluating Zeposia’s long-term safety and effectiveness in 2,494 patients who previously completed a Zeposia clinical trial, including SUNBEAM and RADIANCE. All DAYBREAK participants are receiving one daily capsule of Zeposia (0.92 mg, equivalent to ozanimod HCl 1 mg) for up to seven years or until Celgene discontinues the development program.
The trial’s main goal is to assess the therapy’s safety, while secondary goals include changes in ARRs, the number of two types of brain lesions (T1 and T2), and disability — measured with the expanded disability status scale.
At data cut-off date of Dec. 20, 2019, patients had been treated with Zeposia for a mean of 35.4 months (nearly three years) while in DAYBREAK.
Results showed that patients’ adjusted ARR was very low (0.11 relapses per year) and that most of the patients were relapse-free at two (79%) and three (75%) years. There were no significant changes in the number of both types of brain lesions after two years.
In addition, disability progression was observed in 10.8% of patients at three months and in 8.6% at six months, highlighting that most patients did not experience disease worsening.
Long-term Zeposia was generally well-tolerated, with no new safety concerns identified.
More than 80% of participants reported side effects, with the most frequent being common cold (17.9%), headache (14%), upper respiratory tract infection (9.9%), and low counts of infection-fighting immune cells (9.6%).
A small proportion of patients had a serious adverse event (9.5%) or discontinued treatment due to adverse events (2.2%). There were no reports of serious opportunistic infections.
The occurrence of both adverse events and serious adverse events were similar between patients from different parent trials and showed a trend toward reduction over time.
Overall, the findings suggest that long-term treatment with Zeposia is safe and effectively prevents disease progression in people with relapsing forms of MS.
Data from 14 other Bristol Myers Squibb-sponsored and collaborative studies also will be presented at the meeting.
“At MSVirtual2020, we’re excited to share new findings from DAYBREAK as well as a breadth of studies accelerating our understanding of relapsing forms of multiple sclerosis and adding to our growing body of knowledge of Zeposia,” said Mary Beth Harler, MD, head of Immunology and Fibrosis Development at Bristol Myers Squibb.
“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease,” Harler added.
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