New data for Roche’s OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis

• 85% of treatment-naïve, early-stage relapsing-remitting multiple sclerosis (RRMS) patients achieved no evidence of disease activity (NEDA) in open-label Phase IIIb ENSEMBLE study
• OCREVUS significantly slowed loss of brain tissue within T2 MRI lesions in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of Phase III ORATORIO study
• OCREVUS-treated patients show highest adherence and persistence rates compared with other disease-modifying therapies (DMTs) in two-year U.S. claims analysis
  
  

Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS) as well as demonstrating high persistence and strong adherence to twice-yearly (six-monthly) dosing. These data are being presented virtually at the 73rd American Academy of Neurology (AAN) Annual Meeting from 17–22 April 2021. OCREVUS is the number one prescribed MS medication in the U.S. for patients starting a new treatment, and more than 200,000 people have now been treated with OCREVUS globally.

“All patients regardless of their form of MS experience disease progression from the start. Therefore, we are encouraged by these new analyses showing that early treatment with OCREVUS may significantly control disease progression in both relapsing-remitting MS and in primary progressive MS. Controlling progression can enable people with MS to maintain mobility and limit their disability,” said Levi Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product Development. “In addition, our data show that more people with MS are staying on OCREVUS, the only twice-yearly treatment for MS, compared with other therapies, which may translate to improved outcomes.”

Interim analysis Phase IIIb ENSEMBLE: No evidence of disease progression in early-stage RRMS
OCREVUS treatment provided consistent benefit over one year in patients who were recently diagnosed with RRMS and had not received prior disease modifying treatment (DMT) in an interim analysis of open-label Phase IIIb study ENSEMBLE. After 48 weeks, 85% of OCREVUS-treated patients achieved no evidence of disease activity (NEDA; no relapses, worsening of disability or new or enlarging brain lesions with pre-specified MRI re-baselining at 8 weeks). The average annualised relapse rate across all patients was very low (0.005) and their mean change in Expanded Disability Status Scale score (EDSS) from baseline significantly improved from 1.71 to 1.55 (p=0.002). Additionally, neurofilament light chain (NfL), a marker of nerve cell damage, was reduced to nearly healthy control levels with OCREVUS treatment (10.5 pg/mL at baseline to 4.55 pg/mL at 48 weeks with OCREVUS vs. 4.12 pg/mL in healthy controls). The safety profile of OCREVUS in this trial was consistent with its overall favourable safety profile.