The study found that whilst the higher doses were well tolerated, they failed to have any greater impact than the previously approved 600mg dose measured by way of a composite disability endpoint. Credit: shutterstock / Halfpoint
Roche’s Phase III trial examining higher doses of intravenous (IV) Ocrevus (ocrelizumab) as a means of slowing disability progression in patients living with relapsing multiple sclerosis (MS) has not met its primary endpoint.
Results from the company’s ongoing multi-centre, randomised, double-blind Musette trial (NCT04544436) found that Ocrevus failed to show additional benefit in slowing disability progression but did show low rates or progression consistent with rates observed in previous pivotal studies of IV-delivered Ocrevus.
The study found that whilst the higher doses were well tolerated, they failed to have any greater impact than the previously approved 600mg dose measured by way of a composite disability endpoint over at least 120 weeks of treatment.
The trial saw 864 patients with relapsing MS, selected from 122 international sites, dosed with varying doses of IV-delivered Ocrevus alongside an antihistamine and inflammatory drug methylprednisolone. Patients were split into two arms, with one receiving the currently approved dose of five 600mg infusions of Ocrevus and the other receiving either 1,200mg or 1,800mg, depending on body weight.
Its primary endpoint was the time to first onset of 12-week composite confirmed disability progression (cCDP), defined as any increase on several disability status scales such as the Expanded Disability Status Scale (EDSS).
Despite missing its primary endpoint, the company insists that the therapy showed clinically meaningful results with the lowest annualised relapse rate (ARR) observed during the double-blind period of a Phase III study in relapsing MS.
Roche’s chief medical officer Levi Garraway said: “Ocrevus is the first and only B-cell therapy approved for relapsing MS and primary progressive MS and after more than ten years of treatment, the majority of people with relapsing MS remain free from disease progression.
“These findings reaffirm that the current Ocrevus IV 600mg is optimally dosed to significantly slow disability progression. Moreover, in several predefined analyses on disease activity, Ocrevus showed clinically meaningful results on relapses with relapse occurring approximately once every 16 years, a first for an anti-CD20 RMS medicine.’’
Research by GlobalData estimates that Ocrevus brought in more than $7.5bn last year, with that figure estimated to continue growing to more than $8bn by the end of 2025. Roche reports that Ocrevus was its best-selling drug in 2024, and following approval by the US Food and Drug Association of a subcutaneous version of the therapy in September 2024, Roche believes sales will continue to grow.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in trials examining MS, Tiziana Life Sciences has begun dosing subjects in its placebo-controlled Phase II trial of foralumab. Meanwhile for Roche, its discontinued Alzheimer’s disease drug has shown signs that it could prevent the onset of the disease.
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