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New ocrelizumab data at ECTRIMS advance clinical understanding of underlying progression in multiple sclerosis

Roche Products Limited
Posted on: 27 Oct 17

New ocrelizumab data at ECTRIMS advance clinical understanding of underlying progression in multiple sclerosis

  • Data show ocrelizumab, compared to the comparative control group, significantly reduced disability Progression Independent of Relapse Activity (PIRA) in adults with relapsing forms of multiple sclerosis (RMS)[1]
  • Data demonstrate first method to automatically detect and characterise Slowly Evolving Lesions (SELs) as a potential measure of underlying disease activity in the brain using MRI[2]
  • New results from FLOODLIGHT study suggest smartphone-based disease progression monitoring can augment in-clinic tests, such as hand/arm function and walking behaviour[3]

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new ocrelizumab data are being presented at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting in Paris, France. The data presented showcase clinical advances around underlying disease activity and disability progression in relapsing and progressive forms of multiple sclerosis (MS), through the exploration of newly emerging endpoints and precision monitoring.

Ocrelizumab significantly reduced the proportion of adults with RMS who experienced PIRA in a post-hoc analysis compared to the comparative control groups.1 This effect was particularly seen in those who were potentially at higher risk of progressive disease course based on their baseline Expanded Disability Status Scale (EDSS).1 Specifically, in this analysis, ocrelizumab treatment reduced the risk of PIRA by 25 percent (25.4% vs 19.5%; p=0.008) and 23 percent (19.2% vs 14.8%; p=0.039) more than the comparative control groups, as confirmed at 12 and 24 weeks, respectively..1

PIRA is a newly emerging MS endpoint intended to measure an increase in disability, which is related to underlying disease activity in RMS. These data were generated through a post-hoc analysis of more than 1,600 adults randomly assigned to treatment in OPERA I and OPERA II, and assessed for PIRA, as measured by composite confirmed disability progression (cCDP). cCDP is a measure of the risk of a person’s physical disability getting worse and is based on three measures of physical disability – confirmed disability progression, walking speed and upper extremity function.

 “These new analyses of data from the large controlled studies with ocrelizumab help advance our understanding of how, in relapsing MS, the disease may progress independent of relapses. These insights have implications for daily decisions made together with patients,” said Ludwig Kappos, M.D., Chair of the Department of Neurology, University Hospital, Basel, Switzerland. “Even without experiencing relapses, people with RMS may still have underlying disease activity, which can cause irreversible decline in their mobility and day-to-day quality of life. Recognising and understanding this process supports early indication of more efficacious treatment.”

A platform presentation, also highlighting underlying disease activity, showed that a new algorithm using conventional MRI can be used as a possible biomarker to automatically detect Slowly Evolving Lesions (SELs), as a potential measure of chronic disease activity outside of acute lesions in the brain.2 SELs were shown to evolve independently of acute lesions leading to enhanced focal brain tissue loss, as measured by T1 black hole evolution. Further research is needed, but this algorithm for automatic detection of SELs using conventional brain MRI may provide a marker of chronic disease activity in MS lesions.

 “This new ability to detect both acute and underlying disease activity with conventional MRI may advance the way we monitor for MS progression and how we think about overall patient management,” said Stephen Hauser, M.D., 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. “While we’ve seen SELs can occur across MS subtypes, this finding may be particularly promising for people with PPMS whose worsening of disability may be related to the presence of SELs. This study also highlights the importance of continued research in MS, not only for development of new treatments such as ocrelizumab, but for the insights that are gained about the fundamental cause of this debilitating disease.”

The benefit-risk profile for ocrelizumab was further characterised by the pooled OPERA I, OPERA II and ORATORIO Phase III open-label extension safety data which showed the safety profile in the ocrelizumab treated population was generally consistent with that seen during the controlled treatment period in the RMS and PPMS populations.

New data from the FLOODLIGHT clinical trial programme, which is designed to assess sensor-based outcomes from a series of active neurological tests and passive monitoring through the use of a smartphone, are also being presented. The tool enables a continuous stream of precise, real-world MS disease progression data to be collected and analysed using dedicated algorithms and machine learning.3

Data at ECTRIMS – ACTRIMS demonstrate strong patient adherence to the FLOODLIGHT technology.3 Hand/arm function measured with a smartphone-based pinching test may detect subclinical impairment in those who have normal Nine-Hole Peg Test (9-HPT) performances. Turning speed measured with a smartphone-based U-Turn Test was shown to correlate with the Timed 25-Foot Walk (T25-FW) (p<0.001), and may detect subclinical activity compared to normal in-clinic performances. The data support FLOODLIGHT as a potential complement to in-clinic testing to provide a more complete and consistent picture of a patient’s disease progression.

Ocrelizumab has been licensed for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland. It is currently under review by the European Medicines Agency for licensing in Europe.

 

Notes to Editors:

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 ocrelizumab (600 mg administered by intravenous infusion every six months) compared with the comparative control groups (44 mcg administered by subcutaneous injection three times per week) in 1,656 adults with relapsing forms of MS.[4] In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RMS) and secondary progressive MS (SPMS) with relapses. A similar proportion of patients in the ocrelizumab group experienced serious adverse events and serious infections compared with patients in the comparative control groups.4

About the ORATORIO study in primary progressive MS

ORATORIO is a Phase III, randomised, double-blind, global multi-centre study evaluating the efficacy and safety of ocrelizumab (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 adults with primary progressive MS (PPMS).[5] The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either ocrelizumab or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study.5 A similar proportion of patients in the ocrelizumab group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.5

 

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease for which there is currently no cure, it affects an estimated 2.3 million people around the world, of whom approximately 100,000 live in the UK.[6],[7] MS occurs when the immune system mistakenly attacks the insulation and support around  nerve  cells  (myelin)  in  the  central  nervous  system  (CNS), causing  inflammation  and consequent damage.[8] This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability.[9],[10] MS is typically diagnosed in young adults between the ages of 20-40 years old, when they may be building their careers or planning to have a family, making the disease the leading cause of non-traumatic disability in younger adults.[11]

Relapsing-remitting MS (RMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery.[12] Approximately 85 percent of people with MS are initially diagnosed with RMS.12 The majority of people who are diagnosed with RMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time.[13] Relapsing forms of MS (RMS) include people with RMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease in which disability increases from the outset.[14] Approximately 15 percent of people with MS are diagnosed with the primary progressive form of the disease.14 Currently, there are no licensed treatments for PPMS in the UK.[15]

People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.[16] An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses.[17] Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and worsening disability.15

 

About ocrelizumab

Ocrelizumab is a humanised monoclonal antibody designed to target immune cells with CD20 antigens present on the surface of the cell, including B-cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.4 This nerve cell damage can lead to disability in people with multiple sclerosis (MS).4 Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain immune cells, including B and T-cells but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.4

Ocrelizumab is administered by intravenous infusion every six months.[18] The initial dose is given as two 300 mg infusions given two weeks apart subsequent doses are given as single 600 mg infusions.[19],18

 

About Roche in neuroscience

Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

 

About Roche Products Limited

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology and infectious diseases. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life, safety and survival of patients. Twenty-eight medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. Roche in the UK employs over 2,000 people in pharmaceuticals and diagnostics.

For more information: www.roche.co.uk.

 

For Further information:

Ginnie Tuck

Tel. +44 (0)1707 362949 / 01707 367807

ginnie.tuck@roche.com

 

Roche UK Media Relations Tel. +44 (0)1707 367807

Out of hours: +44 (0)1707 366000                 

welwyn.pr_pharma_uk@roche.com

 

References

[1] Kappos, et al. Ocrelizumab reduces disability progression independent of relapse activity in patients with relapsing multiple sclerosis. In:  7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting; 25-28 October 2017; Paris, France

[2] Elliott, C et al. Detection and characterisation of slowly evolving lesions in multiple sclerosis using conventional

brain MRI. In:  7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting; 25-28 October 2017; Paris, France

[3] P. Mulero, et al. Interim analysis from FLOODLIGHT: a prospective pilot study to evaluate the feasibility of conducting remote patient monitoring with the use of digital technology in patients with multiple sclerosis. In:  7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting; 25-28 October 2017; Paris, France

[4] Hauser SL, et al. (2017). Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med, 376: 221-234.

[5] Montalban, X, et al. (2017). Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med, 376: 209-220

[6] MS Trust. Introduction to MS. Available at: https://www.mstrust.org.uk/understanding-ms/what- ms/introduction-ms. Last accessed: October 2017

[7] National Multiple Sclerosis Society. Who Gets MS? Available at: https://www.nationalmssociety.org/What-is- MS/Who-Gets-MS. Last accessed: October 2017

[8] Multiple Sclerosis Trust. Nerve damage caused by MS. Available at: https://www.mstrust.org.uk/a-z/nerve- damage-caused-ms. Last accessed: October 2017

[9] Ziemssen T. (2005). Modulating processes within the central nervous system is central to therapeutic control of multiple sclerosis. J Neurol, 252(Suppl 5), v38-v45

[10] National Multiple Sclerosis Society. MS symptoms. Available at: http://www.nationalmssociety.org/Symptoms- Diagnosis/MS-Symptoms. Last accessed: October 2017

[11] MS International Federation. What is MS? Available at: https://www.msif.org/about-ms/what-is-ms/. Last accessed: October 2017

[12] Multiple Sclerosis Society. Relapsing Remitting (RRMS). Available at: https://www.mssociety.org.uk/what-is- ms/types-of-ms/relapsing-remitting-rrms. Last accessed: October 2017

[13] Multiple Sclerosis Society. Secondary Progressive MS (SPMS). Available at: https://www.mssociety.org.uk/what- is-ms/types-of-ms/secondary-progressive-spms. Last accessed: October 2017

[14] Multiple Sclerosis Trust. Types of MS. Available at: https://www.mstrust.org.uk/a-z/types-ms. Last accessed: October 2017

[15] Multiple Sclerosis Trust. Disease Modifying Drugs. Available at: https://www.mstrust.org.uk/understanding- ms/ms-symptoms-and-treatments/disease-modifying-drugs-ms-decisions/disease-modifying. Last accessed: October 2017

[16] Erbayat A, et al. (2013). Reliability of classifying multiple sclerosis disease activity using magnetic resonance imaging in a multiple sclerosis clinic. JAMA Neurol, 70(3):338-44

[17] MS Brain Health. Time Matters in Multiple Sclerosis. Available at http://msbrainhealth.org/perch/resources/time- matters-in-ms-report-may16.pdf. Last accessed: October 2017

[18] Multiple Sclerosis Trust. Ocrelizumab (Ocrevus). Available at: https://www.mstrust.org.uk/a-z/ocrelizumab- ocrevus#taking. Last accessed: October 2017

[19] F. Hoffmann-La Roche. A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis. ClinicalTrials.gov NCT01194570. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01194570. Last accessed: October 2017

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Last updated on: 27/10/2017

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