Genentech Shares Promising Results from Phase III OCARINA II Study of Ocrevus for Elapsing, Primary Progressive Multiple Sclerosis

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Genentech announced promising one-year results from the Phase III OCARINA II study, which evaluated Ocrevus (ocrelizumab) in the treatment of patients with both relapsing and primary progressive multiple sclerosis (RMS or PPMS). According to the results, a twice-yearly injection of Ocrevus produced near-complete suppression of clinical relapses and major reductions in brain lesions. Additionally, 97.2% of patients did not experience any relapses during the study period.

Additional findings showed a considerable reduction in T1 gadolinium-enhancing and T2 lesions. In terms of safety, the profile of Ocrevus profile remained consistent with its intravenous (IV) formulation. Common adverse events included injection reactions such as erythema, pain, swelling, and pruritus. The data were presented as an abstract at the American Academy of Neurology’s 76th annual meeting and submitted for approval to both the EMA and FDA, with decisions expected at some point this year.¹

“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,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Genetech, in a press release. “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.”

In October, Genentech released data that showcased life for MS patients after 10 years of treatment with Ocrevus, which showed that 77% of those studied were free of disability progression. Further, 92% of the group were able to continue walking without aid. Specifically, 38% of PPMS patients were found to have no progression of disability after 48 weeks and 80% were still able to walk after a decade of treatment.²

“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,” said Stephen Hauser, MD, chair, scientific steering committee, OPERA studies, director, Weill Institute for Neurosciences at the University of California, San Francisco, in a press release. “These results signify that people with both RMS and PPMS have more years to spend their days living independently without the need for walking aids or wheelchairs.”

According to a study published in the National Library of Medicine, 10% of people living with MS have the primary progressive form, while around 5% have the progressive-relapsing form. Additional findings of the study suggest the following:

• There is a higher number of men effected by PPMS, with most people with this form tending to be older when symptoms begin.
• Individuals with PPMS are more commonly disabled than those with RMS.³

“Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, DO, lead author, Johns Hopkins University School of Medicine, in the press release. “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. Genentech’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. Genetech. April 16, 2024. Accessed April 17, 2024. https://www.gene.com/media/press-releases/15022/2024-04-16/genentechs-subcutaneous-ocrevus-one-year

2. New Data for Genentech’s Ocrevus Show That After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided. BusinessWire. October 12, 2023. Accessed April 17, 2024. https://www.businesswire.com/news/home/20231011545332/en/New-Data-for-Genentech%E2%80%99s-Ocrevus-Show-That-After-10-Years-of-Treatment-77-of-People-With-Relapsing-Multiple-Sclerosis-Were-Free-From-Disability-Progression-and-92-Continue-to-Walk-Unaided

3. Meeting the Needs of People with Primary Progressive Multiple Sclerosis, Their Families, and the Health-Care Community. NLM. Accessed April 17, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3882958/#:~:text=The%20percentage%20of%20people%20with,group%20than%20those%20with%20RRMS.