Roche's (RHHBY) Genentech Announces New Data from OCREVUS Phase 3 in MS

September 14, 2016 6:22 AM EDT
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Genentech, a member of the Roche group (OTC: RHHBY), announced new analyses from the three OCREVUS (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), from September 14-17 in London, England.

OCREVUS increased disease control in patients with RMS and PPMS in separate post-hoc analyses. In these analyses, two composite endpoints measured disease control using a combination of clinical and MRI outcomes: No Evidence of Disease Activity (NEDA) in patients with RMS and No Evidence of Progression (NEP) in patients with PPMS. These composite endpoints are emerging as new treatment targets.

A NEDA analysis of pooled data from the Phase III OPERA I and OPERA II studies compared no evidence of disease activity during different time periods over two years of study. 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. The data showed that OCREVUS significantly increased the proportion of RMS patients achieving NEDA by 75 percent compared with interferon beta-1a over 96 weeks (0-96 weeks, p<0.0001). Additionally, compared with interferon beta-1a, OCREVUS treatment significantly increased the relative proportion of patients achieving NEDA by 33 percent in weeks 0-24 and by 72 percent in weeks 24-96 (both p<0.0001). A majority of patients achieved NEDA in the first 24 weeks of OCREVUS treatment (60.8 percent) and this proportion increased during weeks 24-96 of the study (72.2 percent).

“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS,” said Professor Gavin Giovannoni, Scientific Steering Committee Member of the OPERA I and II studies and Chair of Neurology at Barts and The London School of Medicine and Dentistry. “These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

New post-hoc analyses of the ORATORIO study in PPMS patients measured NEP, which includes three measures of physical disability (confirmed disability progression, walking speed and upper extremity function) and reflects no evidence of worsening of a person’s physical disability. Patients who achieved NEP had no evidence of confirmed disability progression sustained for at least 12 weeks and less than 20 percent worsening of performance on the timed 25-foot walk and 9-hole peg test. OCREVUS treatment significantly increased the proportion of PPMS patients with NEP by 47 percent at week 120 compared with placebo (p=0.0006).

“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said Xavier Montalban, M.D., Ph.D., Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “OCREVUS significantly impacted three key disability measurements, which further highlight its clinical significance in people with primary progressive MS.”

In addition, new patient-reported outcomes data from the ORATORIO study highlighting the unmet need of people with PPMS, including the effect OCREVUS had on fatigue measures, will be presented.

Leading investigators will present the following oral and poster presentations:

Abstract Title

Abstract Number (type),Presentation Date, Time

An exploratory analysis of 12- and 24-week composite confirmed disability progression in patients with primary progressive multiple sclerosis in the ORATORIO trial P746 (poster), Thursday, September 15, 3:45 – 5:00 p.m. BST
Infusion-related reactions with ocrelizumab in relapsing multiple sclerosis and primary progressive multiple sclerosis P720 (poster), Thursday, September 15, 3:45 – 5:00 p.m. BST
Evaluation of no evidence of progression using composite disability outcome measures, in patients with primary progressive multiple sclerosis in the ORATORIO trial 167 (oral), Friday, September 16, 9:51 – 10:03 a.m. BST
Effect of ocrelizumab on magnetic resonance imaging markers of neurodegeneration in patients with relapsing multiple sclerosis: analysis of the Phase III, double-blind, double-dummy, interferon beta-1a-controlled OPERA I and OPERA II studies P1011 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Patient-reported outcomes in the Phase III double-blind, placebo-controlled ORATORIO study of ocrelizumab in primary progressive multiple sclerosis P1279 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Infections and serious infections with ocrelizumab in relapsing multiple sclerosis and primary progressive multiple sclerosis P1248 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Design of two phase III open-label trials evaluating ocrelizumab in patients with relapsing-remitting multiple sclerosis and suboptimal response to disease-modifying treatment P1180 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Baseline assessment of fatigue and health-related quality of life in patients with primary progressive multiple sclerosis in the ORATORIO study P1278 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Exploration and verification of a patient-powered research network to provide patient insights in multiple sclerosis P889 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
NEDA epoch analysis of patients with relapsing multiple sclerosis treated with ocrelizumab: Results from OPERA I and OPERA II, Phase III studies P1593 (poster), Friday, September 16, 3:30 – 5:00 p.m. BST
Real-world treatment observation in multiple sclerosis: development of an online platform to measure patients’ treatment awareness and experiences, access barriers and decision-making ePoster will be displayed on terminals during the congress

Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2016 news and updates by using the hashtag #ECTRIMS2016.

As previously announced, the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for OCREVUS for the treatment of RMS and PPMS, and granted the application Priority Review Designation with a targeted action date of December 28, 2016.

OCREVUS™ is the proprietary name submitted to the FDA for the investigational medicine ocrelizumab.



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