Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from the OCREVUS™ (ocrelizumab) clinical trial programmes will be presented during the 69th American Academy of Neurology (AAN) Annual Meeting in Boston, Massachusetts. The presentations will highlight new efficacy and safety analyses from the OCREVUS Phase II and Phase III trials, as well as from the open-label extensions. Data from these four studies further support OCREVUS as a potential treatment option for patients with relapsing or primary progressive forms of multiple sclerosis (MS).
Within the first eight weeks of treatment, OCREVUS reduced the relapse rate by 55 percent compared with Rebif® (interferon beta-1a) (p=0.0045), in a pooled exploratory analysis of the Phase III OPERA I and OPERA II studies in RMS. In a separate Phase II study in relapsing-remitting MS (RRMS) patients, OCREVUS demonstrated rapid and near-complete suppression of brain MRI activity at eight weeks, including new active areas of damage (T1 gadolinium-enhancing lesions) and new or newly enlarging areas of damage (hyperintense T2 lesions), compared with placebo.
Additional analyses of the Phase III OPERA I and II studies demonstrated the efficacy of OCREVUS in people with early RMS (recently diagnosed and without previous treatment). OCREVUS suppressed more than 90 percent of active MRI lesions over two years compared with interferon beta-1a (p<0.0001) in these patients. In the same early RMS patients, OCREVUS also increased the proportion who achieved No Evidence of Disease Activity (NEDA) by 76 percent compared with interferon beta-1a over two years (p<0.0001). NEDA is achieved when a patient has no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions and no new or enlarging MRI lesions. These data were consistent with NEDA results observed in the overall OCREVUS-treated population.
"The rapid effect seen with OCREVUS in clinical trials provides insight into how this newly FDA-approved therapy could change the way MS is treated," said Stephen Hauser, MD, Chair of the Scientific Steering Committee of the OPERA studies, Director of the Weill Institute for Neurosciences and Chair of the Department of Neurology at the University of California, San Francisco. "Following the FDA approval of OCREVUS for relapsing or primary progressive forms of MS, it is encouraging to see the medicine's favourable benefit-risk profile continue to play out in the data."
In an analysis of pooled data from the Phase III RMS open-label extension (OLE) studies, patients who switched from interferon beta-1a to OCREVUS experienced reductions in relapse rates (unadjusted annualised relapse rate of 0.102 after switching) and MRI brain lesions (0.01 mean number of active lesions (T1 gadolinium-enhancing) and 0.37 new or enlarging T2 lesions after switching). Furthermore, patients who were treated with OCREVUS from the start of the studies showed a sustained benefit after three years.
In the ORATORIO study, PPMS patients with confirmed disability progression (CDP) had a greater increase in fatigue (p=0.0003), underlining the importance of preventing disease progression in people with PPMS. Furthermore, patients treated with OCREVUS who didn’t experience disability progression reported a significant reduction in fatigue compared to those taking placebo (p=0.0337).
Additionally, in open-label extension studies of over 2,200 patients with RMS and PPMS, OCREVUS safety was consistent with the controlled treatment periods.
The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.
OCREVUS is approved for use in the U.S. The OCREVUS Marketing Authorisation Application (MAA) has been validated by the European Medicines Agency (EMA) and is currently under review.
About the OPERA I and OPERA II studies in relapsing forms of MS
OPERA I and OPERA II are Phase III, randomised, double-blind, double-dummy, global multi-centre studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, ...
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