Five Years data in relapsing and primary progressive multiple sclerosis with Ocrevus. Genentech/Roche

Genentech, a member of the Roche Group announced that new Ocrevus (ocrelizumab) data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 10-12 in Berlin, Germany. Five-year data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO show Ocrevus efficacy is maintained on key measures of disease activity and that people treated earlier with Ocrevus had superior disability progression outcomes compared with RMS patients who switched from interferon beta-1 alpha or PPMS patients who switched from placebo.

In the open-label extension of the Phase III OPERA I and OPERA II trials, people with RMS who had continuous Ocrevus treatment over five years had better outcomes in brain atrophy and confirmed disability progression (CDP) than patients who switched to Ocrevus after the first two years of interferon beta-1 alpha treatment. People with RMS who initiated Ocrevus two years earlier maintained lower whole brain, white matter and cortical grey matter tissue loss after five years of continuous treatment. People with RMS who initiated Ocrevus treatment two years earlier achieved significant and sustained reductions in 24-week CDP compared to those who switched from interferon beta-1alpha (16.1 percent vs. 21.3 percent progression after Year 5, respectively, p=0.014).

Additionally, people with RMS who switched to Ocrevus from interferon beta-1 alpha after the controlled trial period had a rapid suppression of disease activity, measured with annualized relapse rate and MRI measures of T1-gadolinium enhancing (T1-Gd+) lesions and new/enlarging T2 (N/E T2) lesions. Switching to Ocrevus reduced the annualized relapse rate from 0.2 pre-switch to 0.07 after three years of Ocrevus treatment. People also experienced near-complete suppression of T1-gadolinium enhancing (T1-Gd+) lesions from 0.49 lesions/scan on interferon beta-1? treatment to 0.004 lesions/scan after three years of Ocrevus treatment. Similarly, the number of new or enlarging T2 (N/E T2) lesions were suppressed from 2.58 to 0.038 lesions/scan.

PPMS patients who were treated with Ocrevus three to five years earlier had less disability progression in the open-label extension study of the Phase III ORATORIO trial. Disability progression was significantly reduced by 9.6 percent in people who were continuously treated with Ocrevus compared with those who switched from placebo as measured by 24-week CDP (p=0.023). Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was significantly reduced by 13.4 percent in people who were continuously treated with Ocrevus compared with those who switched from placebo (p=0.001).

Furthermore, data from the open-label Phase IIIb CHORDS study evaluating Ocrevus in people with relapsing-remitting MS (RRMS) who had a suboptimal response to at least six months of treatment with another disease-modifying therapy will be presented. An interim analysis shows 59 percent of people who switched to Ocrevus had no relapse, no T1-Gd+ lesion MRI, no N/E T2 lesion MRI activity and no 24-week CDP at 48 weeks.

Ongoing safety data presented at ECTRIMS representing 3,811 RMS and PPMS patients and 10,919 patient years of exposure to Ocrevus across all Ocrevus clinical trials, remain consistent with the medicine�s favorable benefit-risk profile.A post-hoc analysis of the ORATORIO study demonstrating Ocrevus treatment increased the proportion of patients with PPMS who achieved no evidence of progression or active disease (NEPAD), a comprehensive measure of MS, compared to placebo were published August 29, 2018 in Annals of Neurology.

See- "Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial"-Jerry S. Wolinsky MD Xavier Montalban MD, PhD Stephen L. Hauser MD Gavin Giovannoni MBBCh, PhD, FCP et al, First published: 29 August 2018 https://doi.org/10.1002/ana.25313.