Roche plans to present data at a major multiple sclerosis (MS) conference indicating the continued efficacy of its investigational Bruton kinase (BTK) inhibitor fenebrutinib, along with data substantiating a sustained two-year risk-benefit- profile for the subcutaneous version of Ocrevus (ocrelizumab).
The company plans to present results from the open-label extension Phase II FENopta study (NCT05119569), which according to Roche, will show that fenebrutinib leads to a near-complete suppression of disease activity maintained at 96 weeks in patients with relapsing MS (RMS). More specifically, patients had a low annualised relapse rate (ARR) of 0.06 and presented with no disability progression, as measured by the Expanded Disability Status Scale (EDSS).
Fenebrutinib is currently in several Phase III trials; two studies in RMS (NCT04586010) and (NCT04586023), and a third for patients with primary progressive MS (PPMS) (NCT04544449). Primary completion dates for the RMS studies are this year, while the PPMS study is expected to complete in 2026, as per ClinicalTrials.gov.
In a bid to strengthen and expand its MS pipeline, Roche has invested in development of next generation BTK inhibitors like fenebrutinib. GlobalData estimates fenebrutinib sales to reach $542m in 2030.
GlobalData is the parent company of Pharmaceutical Technology.
Expanding the scope for Ocrevus
The abstracts on fenebrutinib and Ocrevus will be presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, which started today (24 September) and will take place till 26 September. Among the abstracts is one on the final data from Roche’s Phase III OCARINA II study (NCT05232825). Results indicate that the subcutaneous (SC) injection of Ocrevus exhibited a comparable benefit-risk profile to the well-established delivery route by an intravenous infusion.
The Ocrevus SC injection was approved by the European Commission in June 2024, and later by the US Food and Drug Administration (FDA) in September 2024 as Ocrevus Zunovo.
Additionally, the company is also presenting from an analysis of over 5,000 women in the Ocrevus pregnancy registry that suggests in-utero exposure to Ocrevus does not increase the risk of adverse pregnancy or infant outcomes, nor have significant impact on meaningful antibody responses to childhood vaccine following exposure during pregnancy or breastfeeding. The approval label for Ocrevus includes a note on how animal data suggests the drug’s use may cause foetal harm, information on the registry and more guidelines for pregnant individuals on Ocrevus.
These findings come at a significant time in the lifecycle of Ocrevus, with its anticipated patent expiration in the European Union and United States in 2028 likely to impact revenue. In 2024, Ocrevus yielded CHF 6.7bn ($8.4bn) in sales for Roche, as per its 2024 financial report. Research by GlobalData predict that Ocrevus will bring in $9.01bn in 2028 before estimates start dropping the following year due to the potential introduction of generics.
