Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

Roche’s subcutaneous version of its multiple sclerosis (MS) med Ocrevus triumphed in a key late-stage study, likely setting up a new opportunity for the blockbuster drug.  

The study, called OCARINA II, evaluated the drug as a twice-yearly, 10-minute subcutaneous injection in patients with relapsing MS (RMS) or primary progressive MS (PPMS). Investigators measured the subcutaneous version against the drug's original intravenous infusion formulation over a 24-week period, enrolling 236 patients in total.

When looking at levels of the drug in the blood, the subcutaneous injection closely matched IV Ocrevus. Peak concentrations for the subcutaneous form reached 132 micrograms per milliliter of blood, compared with 137 for the IV form, Roche said.

Ocrevus is a humanized monoclonal antibody that targets CD20-positive B cells, an immune cell that can cause damage to nerve cells and lead to disability in MS patients. The drug works by binding to CD20 surface cell proteins that are expressed on certain B cells.

In its IV formulation, Ocrevus is administered every six months in a four-hour-long infusion, or a shorter two-hour-long infusion which is approved for those who haven’t experienced prior serious infusion reactions. The initial dose is two 300-mg infusions two weeks apart, followed by single 600-mg infusions every six months.

In OCARINA II, both administration forms demonstrated “rapid, sustained and near-complete” B-cell depletion, Roche said.

After 14 days, 97% of patients who received the subcutaneous formulation had five or fewer B cells per microliter of blood, compared with 98% for the IV version. Both levels were sustained over 24 weeks.

The two forms also showed a "near-complete" suppression of MRI lesion activity by 24 weeks, Roche said. Lesion activity can provide a view into patients' disease burden and active inflammation.

About half of the patients in the study had reached 24 weeks of treatment at the time of the analysis. 

Roche will submit the OCARINA II data to health authorities across the globe “in the coming months,” the company said. Roche presented the results at the joint ECTRIMS/ACTRIMS meeting after touting positive top-line results in July.

A subcutaneous injection could open the door to wider usage in treatment centers that don’t have IV infrastructure or that have IV capacity limitations.

The subcutaneous drug utilizes Halozyme's Enhanze drug delivery platform after Roche licensed the tech for $25 million—plus up to $165 million in milestones—back in 2018.

Ocrevus is a major moneymaker for Roche after its original 2017 approval. It generated blockbuster sales in its first full year on the market and last year brought in nearly $7 billion.