Genentech reports data from OCARINA II study of Ocrevus

Genentech, a member of Roche, announced data from the Phase III OCARINA II study of Ocrevus, an investigational twice-yearly, 10-minute subcutaneous, or SC, injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis which reinforce the potential benefits of this investigational formulation. Treatment with Ocrevus SC led to rapid and sustained B-cell depletion in the blood. The data will be presented as an oral presentation at the 76th American Academy of Neurology, or AAN, annual meeting taking place April 13-18 in Denver and has been recognized as an abstract of distinction by the AAN scientific committee. Updated, longer-term results showed that Ocrevus SC injection resulted in near-complete suppression of relapse activity and MRI up to 48 weeks with an ARR of 0.04, and most patients having no T1 gadolinium-enhancing lesions and no new/enlarging T2 lesions. These lesion types are markers of active inflammation and burden of disease, respectively. Additionally, in exploratory patient reported outcome measures patients reported a high level of satisfaction and convenience with Ocrevus SC injection. Additional data continued to show that the safety profile of Ocrevus SC injection was consistent with the well-established safety profile of Ocrevus IV infusion. No new safety signals were identified for Ocrevus SC. The most common adverse events in the Ocrevus SC group were injection reactions, including erythema, pain, swelling and pruritus, all of which were either mild or moderate and none of which led to treatment withdrawal. A total of seven serious AEs were experienced by three and four patients in the Ocrevus SC injection and IV infusion groups, respectively. The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations. Data from the Phase III OCARINA II trial were submitted to health authorities around the world following the first presentation of these results during ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency, or EMA, and FDA have accepted Genentech’s submissions, with a target decision date of mid-2024 for the EMA and September 2024 for the FDA.