Roche has announced that new data on Ocrevus (ocrelizumab) in people with relapsing and primary progressive forms of multiple sclerosis (MS) will be presented during the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting in Paris, France, 25 to 28 October. Eighteen abstracts, including two platform presentations, have been accepted and will be shared during the congress. The data will explore new and existing measures of disease progression, show the effect of Ocrevus on visual outcomes and reinforce its favourable benefit-risk profile.

Research into two newly emerging MS endpoints will be presented, which may help clinicians more closely monitor underlying signs of disease activity that often lead to disability. These data include a post-hoc analysis of the OPERA I and OPERA II studies that shows the impact of Ocrevus in people with relapsing MS (RMS) who experience Progression Independent of Relapse Activity (PIRA), a composite measure examining underlying disease activity independent of any influence of acute relapses. Additionally, in a platform presentation, researchers for the first time will share a new method using conventional brain MRI to automatically detect and characterise Slowly Evolving Lesions (SELs), which may represent a biomarker of chronic disease activity in the brain, versus the acute disease activity in MS lesions.

“The data presented at ECTRIMS – ACTRIMS demonstrate the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase III clinical trials,” said Sandra Horning, M.D., Roche’s chief medical officer and head of Global Product Development. “With our studies of two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease.”
 
In line with this goal, Roche will also present new data from its FLOODLIGHT clinical trial programme investigating sensor-based outcomes from a series of active neurological tests and passive monitoring made possible by the use of a smartphone. The technology enables a continuous stream of precise, real-world MS disease progression data to be collected and analysed using dedicated algorithms and machine learning.

Among other notable data from Roche at ECTRIMS – ACTRIMS are results from the extended controlled period of the Phase III ORATORIO study in primary progressive MS (PPMS), which will show the impact of Ocrevus on sustained reduction in confirmed disability progression. Data from open-label extension periods will also show a safety profile consistent with that seen in controlled treatment periods.

Ocrevus has been approved for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland. Marketing applications for Ocrevus are currently under review in over 50 countries across the world.