Investigational SC Formulation of Ocrelizumab Noninferior to IV Infusion in MS Trial

Positive data were announced from a phase 3 trial evaluating an investigational subcutaneous (SC) formulation of ocrelizumab in patients with multiple sclerosis.

Ocrelizumab, a CD20-directed cytolytic antibody, is currently marketed under the brand name Ocrevus^® as a solution for IV infusion. The global, multicenter, randomized, open-label, parallel group OCARINA II study (ClinicalTrials.gov Identifier: NCT05232825) compared the efficacy and safety of a 10-minute SC injection of ocrelizumab to IV infusion of ocrelizumab in 236 adults with relapsing MS or primary progressive MS. 

The primary endpoint of the study was noninferiority in serum area under the curve (AUC) from day 1 to 12 weeks after SC injection compared with IV infusion. Secondary endpoints included maximum serum concentration of ocrelizumab, the total number of active, gadolinium-enhancing T1 lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12 and 24 weeks.

Findings showed that SC injection of ocrelizumab was noninferior to ocrelizumab administered by IV infusion for AUC over 12 weeks. Additionally, the 2 formulations were found to be similar with regard to controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. Adverse events were observed to be consistent across both groups.

“These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development. “This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’

This article originally appeared on MPR