Clinical Trials Arena

Genentech announces positive 10-year Ocrevus data in MS

A decade-long continuous Ocrevus treatment allowed MS patients to walk unassisted, with many reporting no disability progression.

Genentech, owned by Roche, has announced new clinical and real-world data for Ocrevus (ocrelizumab) for the treatment of patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

The results show that after 10 years of continuous Ocrevus treatment, 77% of patients with RMS had no disability progression and 92% of them continued to walk unassisted. In PPMS patients, 36% had no disability progression based on 48-week confirmed disability progression (CDP) events and 80% of those patients were still able to walk unassisted.

The data has been collected from Phase III Ocrevus open-label extension (OLE) trials. The long-term data has emphasised the importance of early treatment, as patients who were treated earlier in their diagnosis reported better treatment outcomes.

A 10-year safety profile has been curated based on data from 6,155 patients with a combined 28,269 patient-years of exposure to Ocrevus across 12 clinical trials, supporting the long-term safety of the drug.

Safety data from 3,253 cumulative pregnancies in women with MS who received treatment with Ocrevus do not suggest an increased risk of adverse pregnancy or infant outcomes.

Director of the Weill Institute for Neurosciences at the University of California Stephen Hauser said: “Ocrevus is the first B-cell therapy approved for RMS and PPMS and it’s remarkable to see that after 10 years of treatment, a great majority of RMS patients remain free from disease progression.”

Ocrevus was approved for use in MS in 2017, and was Roche’s top-selling pharmaceutical in 2022, according to the annual 2022 report, making $6.7bn. According to GlobalData, Ocrevus sales are expected to rise to $7.4bn by 2029. GlobalData is the parent company of Clinical Trials Arena.

In July of this year, Roche announced that the Phase III OCARINA II trial investigating the efficacy of subcutaneous Ocrevus met all of its primary and secondary endpoints. The approval of subcutaneous Ocrevus would introduce flexibility to MS patients who spend time receiving intravenous Ocrevus.