Roche Announces Positive Phase III Results for Subcutaneous Ocrelizumab in RMS and PPMS

On July 13, Roche announced that the Phase III OCARINA II study of OCREVUS (Ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) met both the primary and secondary endpoints.

Ocrelizumab is a humanized monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell considered a key factor in causing damage to myelin and neuronal axons. Ocrelizumab is the first and only therapy approved for RMS and PPMS, with more than 300,000 patients worldwide having received treatment.

This investigational subcutaneous formulation is made by combining Ocrelizumab with Halozyme Therapeutics' Enhanze drug delivery technology. Ocrelizumab, administered subcutaneously twice a year with each injection taking 10 minutes, is expected to further improve the patient treatment experience and expand its use in multiple sclerosis centers with limited or no intravenous infusion infrastructure.

OCARINA II is a global, multicenter, randomized Phase III study designed to evaluate the pharmacokinetics, safety, imaging, and clinical outcomes of the Ocrelizumab subcutaneous formulation and intravenous infusion in 236 patients with RMS or PPMS. The primary endpoint is the comparison of the 12-week serum area under the curve (AUC) between subcutaneous injection and intravenous infusion. Secondary endpoints include both maximum serum concentration (Cmax), total number of active gadolinium-enhanced T1 lesions at Week 8 and Week 12, the sum of new or enlarging T2 lesions at Week 12 and Week 24, as well as safety and immunogenicity results.

Through 12 weeks of pharmacokinetic measurements, the efficacy of subcutaneous Ocrelizumab was non-inferior to intravenous infusion. Both methods showed comparability in controlling brain MRI lesion activity within 12 weeks, with consistent safety outcomes. Detailed results of the study will be presented at an upcoming medical conference and submitted to health authorities worldwide.

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