Roche’s innovative subcutaneous adaptation of its highly-regarded multiple sclerosis (MS) medication, Ocrevus, has achieved a significant breakthrough in a pivotal late-stage study, potentially paving the way for a new chapter in the drug’s success story. The study, aptly named OCARINA II, meticulously examined the drug’s performance when administered as a subcutaneous injection, offering a more convenient alternative for patients battling relapsing MS (RMS) or primary progressive MS (PPMS). Over the course of 24 weeks, 236 patients participated in this critical evaluation, comparing the subcutaneous form to Ocrevus’ original intravenous infusion formulation.
Intriguingly, the subcutaneous injection closely mirrored the IV Ocrevus in terms of drug levels in the bloodstream. Notably, peak concentrations for the subcutaneous version reached an impressive 132 micrograms per milliliter of blood, a slight distinction from the 137 achieved by the IV form, as confirmed by Roche.
Ocrevus stands out as a humanized monoclonal antibody designed to target CD20-positive B cells, a type of immune cell responsible for potentially harmful nerve cell damage leading to disability in MS patients. The drug’s mechanism of action involves binding to CD20 surface cell proteins expressed on specific B cells.
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“We are pleased to share that Ocrevus 10-minute subcutaneous injection suppressed brain lesions as effectively as the intravenous infusion. Having this additional treatment option may improve the treatment experience for both patients and physicians, and we hope the twice-a-year dosing will offer the same high adherence and persistence.”
– Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development
In its IV formulation, Ocrevus necessitates administration every six months, in a protracted four-hour-long infusion process. This involves an initial dosage of two 300-mg infusions administered two weeks apart, followed by single 600-mg infusions at six-month intervals.
Excitingly, both administration methods in OCARINA II exhibited “rapid, sustained, and near-complete” depletion of B cells, according to Roche. Remarkably, after just 14 days, 97% of patients receiving the subcutaneous version had five or fewer B cells per microliter of blood, closely aligned with the 98% observed in the IV iteration. These promising levels persisted over the 24-week duration of the study.
Moreover, both forms showcased a “near-complete” suppression of MRI lesion activity within 24 weeks, an indicator of the disease burden and active inflammation in patients. Notably, approximately half of the study’s participants had reached the 24-week treatment milestone at the time of analysis.
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Anticipating a promising future for this development, Roche has announced its intention to share the OCARINA II data with health authorities worldwide “in the coming weeks.” This announcement follows the company’s presentation of these groundbreaking results at the joint ECTRIMS/ACTRIMS meeting, which came on the heels of positive top-line results unveiled in July.
The introduction of a subcutaneous injection option holds immense potential, as it may facilitate broader usage, particularly in treatment centers lacking intravenous (IV) infrastructure or grappling with IV capacity constraints. The subcutaneous formulation leverages Halozyme’s Enhanze drug delivery platform, a technology Roche acquired for $25 million, with the potential for up to $165 million in milestone payments back in 2018.
Ocrevus has undeniably become a cornerstone of Roche’s financial success since its initial approval in 2017. In its first full year on the market, it achieved blockbuster sales, and in the previous year, it contributed nearly $7 billion to Roche’s revenue, solidifying its status as a major moneymaker for the company.