Ocrevus Nearly Eliminates MS Relapses and Brain Lesions

Genentech, a Roche subsidiary, has unveiled promising results from its Phase III OCARINA II clinical trial for a new subcutaneous version of Ocrevus (ocrelizumab), a medication for treating multiple sclerosis (MS). The study indicated that this new method of administration significantly cut down on the occurrence of relapses and the development of brain lesions in MS patients, whether they had a relapsing form of the disease or primary progressive MS.

During the 48-week observation period, the new subcutaneous Ocrevus demonstrated an almost complete halt in relapse activity, with a remarkable 97.2% of patients remaining relapse-free throughout the trial's treatment phase. Additionally, MRI scans revealed minimal presence of T1 gadolinium-enhancing lesions and no new or growing T2 lesions, which are both markers of disease activity and inflammation.

An exploratory analysis revealed high levels of patient satisfaction, with 92.3% of participants expressing satisfaction or very satisfaction with the subcutaneous treatment. Furthermore, 90.1% found the treatment to be convenient or very convenient. In terms of safety, the subcutaneous version's side effects profile was similar to that of the currently approved intravenous version, with common side effects including mild to moderate injection reactions, redness, pain, and swelling. Importantly, no patients withdrew from the study due to adverse effects.

Genentech's Chief Medical Officer, Levi Garraway, highlighted that the results show the subcutaneous injection of Ocrevus, which takes only 10 minutes, offers outcomes that are on par with the established benefits of the intravenous form. The company is now engaging with global regulatory bodies with the aim of potentially offering this new treatment option to a broader MS patient population in a more time-efficient manner. The FDA has reviewed Genentech’s submission and is expected to make a decision by September 2024.

Ocrevus is a monoclonal antibody that targets the CD20 protein found on B-cells, and while its precise mode of action is not fully understood, it is thought to promote the destruction of the cells it binds to. Initially approved by the FDA in March 2017 for both relapsing and primary progressive MS, Ocrevus received an additional approval in December 2020 for a reduced infusion time, shortening the treatment duration to two hours from the initial 3.5 hours. Currently, it is only available for intravenous administration.

Genentech's subcutaneous formulation is envisioned to be administered biannually and would only require 10 minutes for injection. If approved, this new method could broaden the accessibility of Ocrevus to treatment centers that lack IV infrastructure or are facing IV capacity constraints.