Subcutaneous Ocrevus Similar to IV Treatment for Patients with PPMS or RMS

Subcutaneous injection of Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) was comparable to the intravenous (IV) infusion formulation of Ocrevus in treating patients with primary progressive multiple sclerosis (PPMS) or relapsing multiple sclerosis (RMS), according to results from the OCARINA II clinical trial (NCT05232825). Subcutaneous Ocrevus was coformulated with the drug delivery technology, Enhanze (rHuPH20; Halozyme Therapeutics, Inc., San Diego, CA) and was administered in a 10-minute injection.

OCARINA II is an ongoing, phase 2, multicenter, randomized study evaluating the safety, pharmacokinetics, and radiologic and clinical effects of subcutaneous Ocrevus compared to IV Ocrevus in 234 participants aged 18 to 65 y with PPMS or RMS. The primary endpoint of this study, serum concentration up to 12 weeks determined by a pharmacokinetic model, was met, showing non-inferiority for subcutaneous Ocrevus vs the IV formulation. Secondary endpoints studied include maximum serum concentration of subcutaneous Ocrelizumab, lesion status according to MRI, incidence of adverse events, percent of participants with adverse events, and proportion of participants achieving a CD19+ B cell level of 5 cells/μL or less, indicating a reduction in autoimmune response. By week 12, all secondary endpoints have also been met, with subcutaneous Ocrevus treatment providing similar control of lesion activity as confirmed by MRI comparable to that of IV Ocrevus, with a consistent safety profile.

"We are delighted that these positive Phase 3 data for OCREVUS administered subcutaneously with ENHANZE opens up the potential for people living with multiple sclerosis to receive their treatment in just 10 minutes, twice a year," said Helen Torley, MB, ChB, MRCP, President and Chief Executive Officer of Halozyme.

Subcutaneous Ocrevus is formulated with Enhanze for injection 2 times per year. Roche, the parent company of Genentech, will seek approval for subcutaneous Ocrevus based these results and forthcoming data from OCARINA II, according to the company’s statement.