High-Dose Ocrevus Falls Short of Primary Endpoint in Relapsing Multiple Sclerosis Trial
In the Phase III MUSETTE study, a higher dose of intravenous Ocrevus (ocrelizumab) did not provide additional benefit in slowing disability progression compared to the currently approved 600mg dose.
Roche has announced results from the Phase III MUSETTE clinical trial of high-dose Ocrevus (ocrelizumab) intravenous (IV) infusion in patients with relapsing multiple sclerosis (RMS). The study did not meet its primary endpoint as high-dose Ocrevus failed to show additional benefit in slowing disability progression compared to the currently approved 600mg dose over a period of at least 120 weeks of treatment.1
In a press release, Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development said: “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. 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."
According to the analysis of the trial, rates of disability progression were low and consistent with rates observed in previous pivotal studies of Ocrevus IV 600mg. Findings from the MUSETTE trial reaffirm that Ocrevus at 600mg is the optimal dose in slowing disease progression.
In April 2024, Roche announced data from the Phase III OCARINA II study of subcutaneous (SC) Ocrevus as an investigational, twice-yearly, 10-minute injection. The company saw positive results from this study, as the injection demonstrated near-complete suppression of clinical relapses and brain lesions in patients with RMS or primary progressive multiple sclerosis.2
In a press release from the time, Garraway said: “With a full year of data demonstrating near-complete suppression of relapse activity and minimal progression of lesion development, this 10-minute subcutaneous Ocrevus injection shows results that are consistent with the long-established benefits of intravenous Ocrevus. We look forward to continuing ongoing conversations with regulatory bodies worldwide to potentially bring an additional treatment option to more people living with MS, in a shorter injection time.”
Longer-term results of the OCARINA II trial showed that SC injection of Ocrevus was consistent with outcomes from the IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks. Additionally, data from exploratory patient reported outcomes showed 92.3% of patients were satisfied or very satisfied with the SC injection and 90.1% felt it was convenient or very convenient.
In the press release, Scott Newsome, DO, lead author, Johns Hopkins University School of Medicine added: "Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS. Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous Ocrevus as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals.”
References
1. Roche provides update on Phase III OCREVUS high dose study in people with relapsing multiple sclerosis. News release. Roche. April 1, 2025. Accessed April 7, 2025. https://www.roche.com/media/releases/med-cor-2025-04-02
2. Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS. News release. Roche. April 16, 2024. Accessed April 7, 2025. https://www.roche.com/media/releases/med-cor-2024-04-17
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