Genentech presents new Ocrevus, fenebrutinib data at ECTRIMS congress

Genentech, a member of Roche (RHHBY), presented new data for Ocrevus and the investigational Bruton’s tyrosine kinase inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain. New data show that treatment with Ocrevus provides significant benefit in preventing disability progression across diverse groups of people with multiple sclerosis, including children with relapsing-remitting multiple sclerosis, women with MS who are pregnant or breastfeeding, and adults with advanced primary progressive multiple sclerosis. From Genentech’s MS pipeline, Phase II data for fenebrutinib showing near-complete suppression of disease activity at 96 weeks will be presented ahead of upcoming pivotal study readouts. Final data from the Phase III OCARINA II study show that Ocrevus subcutaneous injection maintains a consistent benefit-risk profile for up to two years, similar to the well-established Ocrevus intravenous infusion, with continued near-complete suppression of relapses, brain lesion activity and disability progression. The ORATORIO-HAND expanded on the PPMS population studied in the registrational ORATORIO study by including older patients and patients with advanced disability, for whom maintaining upper limb function is even more important for preserving quality of life and independence. Ocrevus shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression in adults with advanced PPMS compared to placebo after a median 2.75 years of treatment in new late-breaking data from the Phase IIIb ORATORIO-HAND study. An even greater reduction of 55% in the risk of time to onset of 12-week cCDP was observed in patients with MRI lesion activity at baseline. In a large PPMS population that included patients with more advanced disease, Ocrevus was superior to placebo in delaying overall disability progression and worsening of upper limb function. The safety profile of Ocrevus was consistent with previous studies, and no new safety signals were reported. Ocrevus is the first and only approved treatment for PPMS, and these data demonstrate that the benefit extends to patients with more advanced disease. Two-year data from the Phase II FENopta open-label extension study will be presented, showing that patients with relapsing multiple sclerosis treated with fenebrutinib maintained near-complete suppression of disease activity at 96 weeks. Patients enrolled in the OLE had a low annualized relapse rate of 0.06, and during this time, there was no disability progression, as measured by the EDSS. At two years, MRI scans detected zero new T1 gadolinium-enhancing lesions, which are markers of active inflammation. Neurofilament light chain, a marker of nerve cell damage, was decreased to healthy donor range in the first year and maintained in the second year of fenebrutinb treatment. Three Phase III clinical trials for fenebrutinib are ongoing, including the FENhance I and II studies in RMS and the FENtrepid study in PPMS. Initial data from the FENtrepid study are expected at the end of this year.