Positive Results from Phase 3 MS Trial of Roche OCREVUS with Halozyme Drug Delivery Tech

 Halozyme Therapeutics, Inc. announced that Roche's Phase 3 OCARINA II trial evaluating OCREVUS® (ocrelizumab) with ENHANZE® as a twice a year 10-minute subcutaneous (SC) injection, met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS (RMS or PPMS). CREVUS subcutaneous injection co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior to OCREVUS given by intravenous infusion (IV) as measured by pharmacokinetics (levels in the blood) at 12 weeks. OCREVUS subcutaneous injection also was comparable to OCREVUS IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks.

The safety profile of OCREVUS subcutaneous injection was consistent with that of OCREVUS IV. The subcutaneous formulation of OCREVUS with ENHANZE® retains the twice-yearly dosing regimen of OCREVUS IV that has shown high persistence and adherence since becoming a standard of care MS treatment, potentially providing an additional delivery option for patients and healthcare professionals. Roche will share detailed results from the OCARINA II trial at an upcoming medical meeting and submit the data for regulatory approval to health authorities globally.

OCARINA II is a global Phase III multicentre, randomised study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous formulation of OCREVUS compared with OCREVUS IV in 236 patients with RMS or PPMS. The primary endpoint is non-inferiority in a serum model-predicted area under the curve (AUC) from day 1 to 12 weeks after subcutaneous injection compared to IV infusion. Secondary endpoints include maximum serum concentration (Cmax) of OCREVUS, 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, as well as safety, immunogenicity and biomarker outcomes. Exploratory endpoints include patient-reported outcomes.

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