Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from the Phase III OCARINA II study (S31.006) of Ocrevus (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) 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 (AAN) Annual Meeting taking place April 13-18 in Denver and has been recognized as an abstract of distinction by the AAN scientific committee.

“With a full year of data demonstrating near-complete suppression of relapse activity and minimal progression of lesion development, this 10-minute subcutaneous Ocrevus injection shows results that are consistent with the long-established benefits of intravenous Ocrevus,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “We look forward to continuing ongoing conversations with regulatory bodies worldwide to potentially bring an additional treatment option to more people living with MS, in a shorter injection time.”

Updated, longer-term results showed that Ocrevus SC injection (920 mg; n=236; both treatment arms [OCR SC/SC and OCR IV/SC]) resulted in near-complete suppression of relapse activity (97.2% had no relapse during the treatment phase) and MRI up to 48 weeks with an ARR of 0.04, and most patients having no T1 gadolinium-enhancing (T1 Gd+) 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 (n=52) patients reported a high level of satisfaction (92.3% were satisfied or very satisfied) and convenience (90.1% felt it was convenient or very convenient) with Ocrevus SC injection.

“Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine. “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous Ocrevus as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals.”