Roche provides update on phase III Ocrevus (ocrelizumab) high dose study in people with relapsing multiple sclerosis

Roche announced that the Phase III MUSETTE trial comparing a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion to the currently approved Ocrevus IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability endpoint over a period of at least 120 weeks of treatment. The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg. In addition, in several predefined analyses on disease activity, Ocrevus IV 600 mg showed clinically meaningful results with the lowest annualised relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS. The high dose was well tolerated with an overall comparable safety profile to Ocrevus  IV 600 mg and no new safety signals observed. The MUSETTE data further support the efficacy and safety profile of the currently approved Ocrevus V 600 mg dose for RMS.

MUSETTE (NCT04544436) is a Phase III randomised, double-blind, controlled, parallel-group, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of a high dose of Ocrevus intravenous (IV) infusion (1,200 mg for patients <75 kg or 1,800 mg for patients ≥75 kg) in adult patients with relapsing multiple sclerosis (RMS) compared with the currently approved Ocrevus  IV 600 mg dose. Patients received treatment with Ocrevus  high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks.

The primary endpoint was the time to first onset of 12-week composite confirmed disability progression (cCDP), defined as any of the following events sustained for 12 weeks: an increase of ≥1.0 point from the baseline Expanded Disability Status Scale (EDSS) score if the baseline EDSS score was ≤5.5 or an increase of ≥0.5 points if the baseline EDSS score was >5.5; a ≥20% increase in time to perform the timed  7.5 m or  25-foot walk (T25FW); a ≥20% increase in time to perform the nine-hole peg test (9HPT). Full data from MUSETTE will be presented at an upcoming medical meeting.

“OCREVUS is the first and only B-cell therapy approved for RMS and PPMS and after more than ten years of treatment, the majority of people with RMS remain free from disease progression,” said Dr.. Levi Garraway,, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings reaffirm that the current OCREVUS IV 600 mg is optimally dosed to significantly slow disability progression. Moreover, in several predefined analyses on disease activity, OCREVUS showed clinically meaningful results on relapses with a relapse occurring approximately once every 16 years, a first for an anti-CD20 RMS medicine.’’