Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017
SergVladimirov 21 окт. | 16:58
DARMSTADT, Germany, October 18, 2017/PRNewswire/ --
Not intended for US/UK based media
Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017
• Important safety and immune cell analyses further characterize the selective immune reconstitution approach of Mavenclad
• Continued innovation with Rebif includes analysis of NEDA and use of MAGNIMS criteria in predicting clinical outcomes out to 15 years
• Pre-clinical data for investigational evobrutinib highlight potential role in patients with relapsing MS
• A total of 40 abstracts will be presented by lead investigators
Merck, a leading science and technology company, today announced that data for approved and investigational multiple sclerosis (MS) treatments, MAVENCLAD®(Cladribine Tablets) and Rebif® (interferon beta-1a) and evobrutinib will be presented at MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting, 25-28 October 2017 in Paris, France. Efficacy data will be presented from the CLARITY, CLARITY Extension and ORACLE-MS trials which highlight that MAVENCLAD® delivers and sustains 4 years of disease control with a maximum of 20 days of oral treatment in the first 2 years. Additional safety analysis assessing malignancy and infection risk will be presented along with data for MAVENCLAD® which further detail how the treatment is thought to selectively target the adaptive immune system.
Data presentations for Rebif® will focus on long-term disease activity assessed by the MAGNIMS (Magnetic Resonance Imaging in MS) score. Real-world evidence presentations will evaluate relapse rates in patients newly initiating on Rebif®, and an assessment of treatment adherence rates for patients treated with Rebif® compared with dimethyl fumarate.
Furthermore, key preclinical data will be presented for Merck's investigational evobrutinib (M2951), a Bruton's tyrosine kinase (BTK) inhibitor, which is thought to be important in the development and functioning of various immune cells including B lymphocytes, specifically in patients with MS.
"The breadth of data being presented at this year's congress underpin Merck's commitment to deepening the understanding of how our portfolio of products, whether approved or investigational, target MS, and reinforce our dedication to provide differentiated treatment options to physicians and people living with MS," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck.
In addition to data presentations, two Merck-sponsored symposia will take place during the meeting:
• Balancing benefits and risks of DMDs in MS, Thursday, October 26, 18:00-19:00, Hall A
• Potential solutions to treatment burden in MS, Friday, October 27, 08:00-09:00, Hall A
On Wednesday, October 25, from 9:30-11:30am CEST, Merck will be hosting a press event briefing with members of the leadership team and lead investigators. A link to view this event will be available for media offsite, please contact ectrimspressevent@merckgroup.com for further information. Additionally, at 19:30pm CEST, Merck will be hosting a session highlighting data from a report which will be published during MSParis 17 entitled, Addressing the Socio-economic impact of Multiple Sclerosis on Women in Europe.
On Thursday, October 26, Merck will also be hosting the annual Grant for Multiple Sclerosis Innovation (GMSI) Award Event at the Palais des Congres, Havane Theatre. The award, first launched at ECTRIMS in 2012, supports the advancement of science and medical research in the field of MS, and provides a grant of up to €1,000,000 per year to one or more selected research projects.
On Friday, October 27, MS in the 21st Century (Merck sponsored initiative involving a joint Steering Group of international healthcare professionals and MS patient advocates) will host their first educational workshop titled 'Two monologues do not make a dialogue - Overcoming communications barriers between healthcare professionals and patient', to encourage better communication between healthcare professionals and people with MS. As part of this workshop, two new communication tools will also be launched: 'my/MS Priorities' and 'my/MS Commitments', both of which are designed to be used jointly with people with MS and their healthcare team to improve the quality and efficiency of clinical consultations and disease management.
For up-to-date information and activities during ECTRIMS 2017, follow Merck on Twitter (@MerckHealthcare or #AddressMS) or visit booth 08.
The following MAVENCLAD® and Rebif® global abstracts have been accepted for presentation at MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting:
https://www.prnewswire.com/news-releases/merck-to-present-new-data-on-ms-portfolio-rebif-mavenclad-and-evobrutinib-at-ectrims-2017-300538735.html
About MAVENCLAD®
MAVENCLAD® (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis[*] (RMS). MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS).
MAVENCLAD® is currently under clinical investigation and not yet approved for the treatment for any use in the United States or Canada. In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
The clinical development program for MAVENCLAD® includes:
• The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD® as a monotherapy in patients with RRMS.
• The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of MAVENCLAD® over an extended administration for four years.
• The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD®as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
• The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding MAVENCLAD® treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
• PREMIERE (Prospective Observational Long-term Safety Registry of Multiple
Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of MAVENCLAD®. This includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.
EU Indication
MAVENCLAD® (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.
Important EU Safety Information
Contraindications:
MAVENCLAD® is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance
Not intended for US/UK based media
Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017
• Important safety and immune cell analyses further characterize the selective immune reconstitution approach of Mavenclad
• Continued innovation with Rebif includes analysis of NEDA and use of MAGNIMS criteria in predicting clinical outcomes out to 15 years
• Pre-clinical data for investigational evobrutinib highlight potential role in patients with relapsing MS
• A total of 40 abstracts will be presented by lead investigators
Merck, a leading science and technology company, today announced that data for approved and investigational multiple sclerosis (MS) treatments, MAVENCLAD®(Cladribine Tablets) and Rebif® (interferon beta-1a) and evobrutinib will be presented at MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting, 25-28 October 2017 in Paris, France. Efficacy data will be presented from the CLARITY, CLARITY Extension and ORACLE-MS trials which highlight that MAVENCLAD® delivers and sustains 4 years of disease control with a maximum of 20 days of oral treatment in the first 2 years. Additional safety analysis assessing malignancy and infection risk will be presented along with data for MAVENCLAD® which further detail how the treatment is thought to selectively target the adaptive immune system.
Data presentations for Rebif® will focus on long-term disease activity assessed by the MAGNIMS (Magnetic Resonance Imaging in MS) score. Real-world evidence presentations will evaluate relapse rates in patients newly initiating on Rebif®, and an assessment of treatment adherence rates for patients treated with Rebif® compared with dimethyl fumarate.
Furthermore, key preclinical data will be presented for Merck's investigational evobrutinib (M2951), a Bruton's tyrosine kinase (BTK) inhibitor, which is thought to be important in the development and functioning of various immune cells including B lymphocytes, specifically in patients with MS.
"The breadth of data being presented at this year's congress underpin Merck's commitment to deepening the understanding of how our portfolio of products, whether approved or investigational, target MS, and reinforce our dedication to provide differentiated treatment options to physicians and people living with MS," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck.
In addition to data presentations, two Merck-sponsored symposia will take place during the meeting:
• Balancing benefits and risks of DMDs in MS, Thursday, October 26, 18:00-19:00, Hall A
• Potential solutions to treatment burden in MS, Friday, October 27, 08:00-09:00, Hall A
On Wednesday, October 25, from 9:30-11:30am CEST, Merck will be hosting a press event briefing with members of the leadership team and lead investigators. A link to view this event will be available for media offsite, please contact ectrimspressevent@merckgroup.com for further information. Additionally, at 19:30pm CEST, Merck will be hosting a session highlighting data from a report which will be published during MSParis 17 entitled, Addressing the Socio-economic impact of Multiple Sclerosis on Women in Europe.
On Thursday, October 26, Merck will also be hosting the annual Grant for Multiple Sclerosis Innovation (GMSI) Award Event at the Palais des Congres, Havane Theatre. The award, first launched at ECTRIMS in 2012, supports the advancement of science and medical research in the field of MS, and provides a grant of up to €1,000,000 per year to one or more selected research projects.
On Friday, October 27, MS in the 21st Century (Merck sponsored initiative involving a joint Steering Group of international healthcare professionals and MS patient advocates) will host their first educational workshop titled 'Two monologues do not make a dialogue - Overcoming communications barriers between healthcare professionals and patient', to encourage better communication between healthcare professionals and people with MS. As part of this workshop, two new communication tools will also be launched: 'my/MS Priorities' and 'my/MS Commitments', both of which are designed to be used jointly with people with MS and their healthcare team to improve the quality and efficiency of clinical consultations and disease management.
For up-to-date information and activities during ECTRIMS 2017, follow Merck on Twitter (@MerckHealthcare or #AddressMS) or visit booth 08.
The following MAVENCLAD® and Rebif® global abstracts have been accepted for presentation at MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting:
https://www.prnewswire.com/news-releases/merck-to-present-new-data-on-ms-portfolio-rebif-mavenclad-and-evobrutinib-at-ectrims-2017-300538735.html
About MAVENCLAD®
MAVENCLAD® (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis[*] (RMS). MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS).
MAVENCLAD® is currently under clinical investigation and not yet approved for the treatment for any use in the United States or Canada. In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
The clinical development program for MAVENCLAD® includes:
• The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD® as a monotherapy in patients with RRMS.
• The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of MAVENCLAD® over an extended administration for four years.
• The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD®as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
• The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding MAVENCLAD® treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
• PREMIERE (Prospective Observational Long-term Safety Registry of Multiple
Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of MAVENCLAD®. This includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.
EU Indication
MAVENCLAD® (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.
Important EU Safety Information
Contraindications:
MAVENCLAD® is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance
