Roche's Once-Semiannual Subcutaneous Ocrevus Demonstrates Near-Complete Suppression of Relapses in Multiple Sclerosis

Apr 26, 2024 18:13 CST Updated 11:13

Roche

Oncology Drug Research, Development, and Manufacturing

Genentech

Pharmaceutical R&D Manufacturer

▎WuXiEdited by Kant Content Team

Recently, Genentech, a subsidiary of Roche, announced positive data from the Phase 3 clinical study OCARINA II for its key antibody therapy Ocrevus (ocrelizumab) in treating relapsing or primary progressive multiple sclerosis (RMS or PPMS). The results showed,Ocrevus Subcutaneous Formulation, with Just Two Doses per Year, Nearly Completely Suppresses Clinical Relapses and Brain Lesions. The regulatory submission for the Ocrevus subcutaneous formulation is currently under review by European and U.S. regulatory authorities and is expected to gain approval this year.

Updated long-term follow-up results show thatOcrevus Subcutaneous Injection (920 mg; n=236) Nearly Completely Suppressed Relapse Activity (97.2% of Patients Had No Relapses During Treatment). The Annualized Relapse Rate at 48 Weeks, as Measured by Magnetic Resonance Imaging (MRI), was 0.04, with the Majority of Patients Showing No Evidence of...Gd+T1Lesions and no new/enlarging T2 lesions.These lesion types are markers of active inflammation and disease burden, respectively. Additionally, in exploratory patient-reported outcome measures, patients（n=52）Reported high levels of satisfaction (92.3% of patients felt satisfied or very satisfied) and convenience (90.1% of patients found it convenient or very convenient).

Additional data continue to show that the safety of Ocrevus subcutaneous injection is consistent with the established safety of Ocrevus intravenous infusion. No new safety signals were identified. The most common adverse events in the Ocrevus subcutaneous injection group were injection-related reactions (51.5% of all treated patients), including erythema (34.8%), pain (17.2%), swelling (9.4%), and pruritus (5.6%). All these adverse events were mild or moderate and did not lead to treatment discontinuation.

Image Source: 123RF

The press release pointed out that thisA subcutaneous injection formulation administered once every six months, with each administration taking only 10 minutes, has the potential to expand the use of Ocrevus in treatment centers without infusion facilities or with limited infusion capabilities.The European Medicines Agency (EMA) and the U.S. FDA have accepted Genentech's regulatory submissions, with the EMA’s target decision date set for mid-2024 and the FDA’s target decision date set for September 2024.

Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells., a specific type of immune cell considered a key factor in myelin and axonal damage. Globally, more than 300,000 patients have been treated with Ocrevus through intravenous infusion. This formulation has been approved in over 100 countries and regions, including North America, South America, the Middle East, Eastern Europe, Asia, Australia, Switzerland, the UK, and the EU.

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. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240416088195/en

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