Phase III trials of Ocrevus show efficacy and safety in multiple sclerosis.

Ocrevus data from all clinical trials consistently show a favorable benefit-risk profile over eight years. Genentech and research partners will also present four late-breaking abstracts to share the latest data regarding COVID-19 and vaccine response in patients treated with Ocrevus.

Long-term Ocrevus treatment continues to demonstrate sustained reduction in disability progression and suppression of disease activity in people with RMS. Earlier intervention with Ocrevus resulted in a 35% reduction in the risk of patients with RMS needing a walking aid over 7.5 years compared with patients who switched from interferon beta-1a to Ocrevus after the 96-week double-blind period (5.2% vs. 7.0%, respectively; 95% CI: 0.65 [0.44–0.97]; p=0.034). The risk was measured by the length of time until a person reached a score on the Expanded Disability Status Scale of 6 or greater (EDSS at least 6) that was sustained for at least 48 weeks in a post-hoc analysis. Data also showed that switching from interferon beta-1a to Ocrevus at the start of the OLE period was associated with a rapid and robust reduction in annualized relapse rate (ARR) that was maintained through the 5.5-year OLE period. ARR was 0.2 pre-switch, 0.1 after one year of Ocrevus treatment and 0.03 after 5.5 years of Ocrevus treatment in the OLE. Ocrevus continuers maintained a low ARR of 0.03 after 7.5 years of Ocrevus treatment.

After eight years, outcomes continue to favor early and ongoing treatment with Ocrevus to slow disability progression in people with PPMS. Earlier intervention with Ocrevus resulted in a 29% reduction in 48-week confirmed disability progression (CDP) in patients with PPMS over eight years compared with patients who switched to Ocrevus from placebo after the double-blind period of at least 120 weeks (95% CI: 0.71 [0.57–0.87]; p=0.001). A 24% (95% CI: 0.76 [0.62–0.92]; p=0.005) reduced risk of recurrent 48-week CDP (re-baselining EDSS after onset of CDP event) was seen in patients who were continuously treated with Ocrevus compared with those who switched from placebo. Many people with PPMS eventually transition into a wheelchair; therefore, maintaining the ability to use their hands and arms is important for these patients. Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was also reduced in patients who were continuously treated with Ocrevus compared with those who switched from placebo (95% CI: 0.66 [0.50–0.86] respectively; p=0.002).

New safety data as of November 2020 will be presented, representing 5,688 patients with RMS and PPMS and 21,675 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. These findings further demonstrate the consistently favorable benefit-risk profile of Ocrevus over eight years.

These data are being presented virtually at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).