Long-Term Zeposia Data Show Lasting Efficacy and Safety in Relapsing Multiple Sclerosis

Bristol Myers Squibb has released new data from the Phase 3 DAYBREAK trial, revealing that Zeposia (ozanimod) effectively reduces the rate of brain volume loss in patients with relapsing forms of multiple sclerosis (RMS). The findings indicate that patients who received continuous Zeposia treatment over a period of up to five years experienced minimal and consistent whole brain volume (WBV) loss, with annualized least squares mean (LSM) percentage changes from the parent trial baseline through Month 60 showing −0.27 for RADIANCE and −0.35 for SUNBEAM.

The DAYBREAK trial encompassed patients from the SUNBEAM and RADIANCE Phase 3 trials, totaling 2,257 participants. The trial showed that transitioning from interferon beta-1a (IFN-β) to Zeposia consistently lessened the rates of WBV loss. Specifically, the annualized LSM percentage change from the RADIANCE baseline to Month 24 and DAYBREAK baseline to Month 24 was −0.48 and −0.19 respectively, with similar results noted in the SUNBEAM trial. Furthermore, reductions in thalamic volume loss were also observed, demonstrating Zeposia's efficacy in preserving brain volume.

Another significant outcome from the DAYBREAK trial was the safety profile of Zeposia. The safety analysis included 762 patients who had continuous Zeposia treatment for a median duration of 83.9 months. Over time, the incident rates of treatment-emergent adverse events (TEAEs) declined significantly. For instance, the overall TEAEs incident rate dropped from 896.1 per 1,000 person-years in the Phase 3 trials to 101.7 by Month 60 or later in the DAYBREAK OLE trial. Similar declines were seen in the rates of infections, serious infections, opportunistic infections, as well as cardiac, hepatic, and pulmonary disorders.

Dr. Jeffrey Cohen from the Mellen Center for Multiple Sclerosis at Cleveland Clinic highlighted the importance of early treatment for multiple sclerosis to prevent significant and irreversible brain volume loss. He emphasized that the new analyses reinforce Zeposia's well-established safety and efficacy as an oral therapy, particularly for newly diagnosed patients with relapsing forms of multiple sclerosis.

Alyssa Johnsen, senior vice president and head of clinical development in Immunology, Cardiovascular, and Neuroscience at Bristol Myers Squibb, noted that the ECTRIMS data further corroborates Zeposia's long-term safety and efficacy. She emphasized that these findings contribute to the growing evidence of Zeposia's potential to mitigate disease progression, underscoring Bristol Myers Squibb's commitment to advancing neurological disease treatments.

The DAYBREAK trial was a Phase 3, multi-center, long-term open-label extension study aimed at evaluating the safety and efficacy of Zeposia in RMS patients. It included those diagnosed with RMS from the RADIANCE, SUNBEAM, and RPC01-1001 trials, who continued to receive Zeposia until the trial's conclusion.

The SUNBEAM and RADIANCE trials were pivotal, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 trials assessing the efficacy, safety, and tolerability of Zeposia compared to weekly intramuscular Avonex®. These trials included over 1,300 patients each, spanning numerous sites and countries. The primary endpoint was the annualized relapse rate over the treatment period, with secondary endpoints including MRI assessments of brain lesions and volume changes.

Multiple sclerosis (MS) is a debilitating disease where the immune system attacks the myelin sheath protecting the nerves, leading to disrupted brain-body communication and potentially irreversible nerve damage. Around 2.9 million people globally and 700,000 in Europe are affected by MS, with relapsing forms of MS (RMS) being the most common at diagnosis.

Bristol Myers Squibb remains dedicated to advancing treatments for neurological disorders by leveraging genetics, biomarkers, and predictive sciences to develop therapies aimed at optimizing patient outcomes.