Ocrevus twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions.- Genentech/Roche

Study results demonstrate the effect of Ocrevus (ocrelizumab) as an investigational twice-yearly, 10-minute subcutaneous injection on pharmacokinetic, biomarker, and MRI measures in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). The data will be presented in a poster at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).

“We are pleased to share that Ocrevus 10-minute subcutaneous injection suppressed brain lesions as effectively as the intravenous infusion,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Having this additional treatment option may improve the treatment experience for both patients and physicians, and we hope the twice-a-year dosing will offer the same high adherence and persistence.”

Ocrevus subcutaneous injection was non-inferior to Ocrevus IV infusion as measured by Ocrevus levels in the blood of patients (area under the serum concentration time curve) from day 1 to 12 weeks (3500 day µg/mL for subcutaneous injection vs. 2750 day µg/mL for IV infusion). Peak Ocrevus blood (serum) concentrations were similar for subcutaneous injection (132 µg/mL) and IV infusion (137 µg/mL). Ocrevus subcutaneous injection provided rapid, sustained and near-complete B-cell depletion that was similar to Ocrevus IV infusion (97% and 98% of patients respectively had B cell levels of 5 cells/µL or less when first measured at 14 days), which was sustained over 24 weeks. At the time of analysis, approximately half the patients in the study had reached 24 weeks of treatment.

Both Ocrevus subcutaneous injection and Ocrevus IV infusion resulted in rapid and near-complete suppression of MRI lesion activity by 24 weeks, with most patients having no T1 gadolinium-enhancing (T1 Gd+) lesions, which are markers of active inflammation, and no new/enlarging T2 lesions, which represent the amount of disease burden or lesion load at 24 weeks.

The safety profile of Ocrevus subcutaneous injection was consistent with the well-established safety profile of Ocrevus IV infusion . No new safety signals were identified for Ocrevus subcutaneous injection. The most common adverse events in the Ocrevus subcutaneous injection group were injection reactions (48% of all exposed patients), all of which were either mild or moderate. The most common AEs in the Ocrevus IV infusion group were infusion-related reactions (17%). A total of 4 and 7 serious AEs were experienced by 3 (2.5%) and 4 (3.4%) patients in the Ocrevus subcutaneous and IV infusion groups, respectively.