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EMD Serono to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis
- Company to present 54 abstracts across its MS portfolio - MAVENCLAD® (cladribine) tablets, Rebif® (interferon beta-1a) and investigational evobrutinib
- New data and real-world evidence further characterize the efficacy and safety profiles of MAVENCLAD®
- New MAVENCLAD® and Rebif® safety data to be shared regarding risk of respiratory viral infections
ROCKLAND, Mass, Sept. 3, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. The Company will present 54 abstracts at the meeting, taking place virtually from September 11-13, 2020, including new efficacy and real-world safety data on MAVENCLAD® (cladribine) tablets and new safety data for Rebif® (interferon beta-1a).
In addition, data will be presented on the efficacy profile of evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase inhibitor (BTKi), through 108 weeks of treatment in the Phase II open-label extension (OLE) in adult patients with relapsing multiple sclerosis (RMS). Preclinical data will also be presented providing insights into evobrutinib's potential impact on progression in MS.
"The broad range of research revealed through these data demonstrate our strategic approach to advancing the MS treatment landscape through new medicines and patient-focused research initiatives," said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "Much of our data provide insights on how MAVENCLAD® and Rebif® affect the risk of respiratory viral infections and COVID-19 outcomes in MS patients. These insights will help support clinicians as they make treatment decisions for their patients living with MS."
Key MAVENCLAD® (cladribine) tablets data include:
- Efficacy results from the Phase IV MAGNIFY-MS study and its impact on a reduction in mean combined unique active (CUA) lesion count in the first six months of MAVENCLAD® treatment for highly active RMS
- New data evaluating cumulative relapse incidence over five years in patients enrolled in the MAVENCLAD® CLARITY and CLARITY Extension trials
- Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD®, with eight to 14 years of follow up, will be available as part of the late-breaker sessions from September 25, 2020
- Results from a post hoc analysis from the CLARITY Extension and the impact of MAVENCLAD® on the prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS)
- Results from the MAGNIFY and CLARIFY studies regarding clinical outcomes in patients with COVID-19 infection during these Phase IV studies of MAVENCLAD® for the treatment of MS will be available as part of the late-breaker sessions from September 25, 2020
- Updated post-approval safety data of MAVENCLAD® in the treatment of MS, including respiratory viral infections and findings that the safety profile was consistent with that from the clinical development program
Key Rebif® (interferon beta-1a) data include:
- Post-approval results on the safety of Rebif® in the treatment of MS, showing no new safety signals
Key evobrutinib data include:
- Efficacy results of the Phase II OLE in patients treated with evobrutinib 75 mg BID (twice a day) as measured by annualized relapse rate from Week 48 to Week 108
- Safety results from the ≥60 week Phase II OLE
- Preclinical data demonstrating evobrutinib's potential to reduce CNS compartmentalized inflammation thought to drive the progression of disability seen in MS
Additional EMD Serono activities at MSVirtual2020:
- Live presentation "Exploring the role of real-world data in multiple sclerosis" chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry (September 12, 2020, 14:30–15:30 EDT; recording available after the event)
- Two product theatres on demand throughout the congress starting from September 11, 2020, 11:45 EDT
- "Multiple sclerosis patient management: update from the UK" by Dr. Wallace Brownlee, MS Specialist Neurologist, National Hospital for Neurology and Neurosurgery, and MS researcher at Queen Square MS Centre, University College London Institute of Neurology
- "Real-world multiple sclerosis management: what can we learn from MSBase?" by Dr. Suzanne Hodgkinson, Associate Professor, University of New South Wales, and a senior consultant neurologist at Liverpool Hospital, New South Wales, Australia
Following the conclusion of MSVirtual2020, EMD Serono will be hosting "Mastering the Neuroscience of Unconscious Bias," the inaugural virtual event for the company`s I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is a US-based initiative started by the Neurology & Immunology franchise, which aims to explore solutions together with healthcare providers to improve equity within the healthcare ecosystem.
Below is the full list of EMD Serono abstracts accepted for presentation at ACTRIMS-ECTRIMS 2020:
MAVENCLAD® (cladribine) tablets Presentations | |||
Title | Authors | Presentation ID | Presentation Details |
Reduced Grey Matter | Battaglini M, Alexandri N, De | P0231 | Session: ePoster Date: September 11- Time: Available from Presenter: Marco |
Reduction in CUA MRI | De Stefano N, | P0382 | Session: ePoster Date: September 11- Time: Available from Presenter: Nicola De |
Durable Efficacy of | Giovannoni G, | P0202 | Session: ePoster Date: September 11- Time: Available from Presenter: Gavin |
Disability Improvement | Sormani M P, | P0201
| Session: ePoster Date: September 11- Time: Available from Presenter: Maria Pia |
Updated Post-Approval | Giovannoni G, | P0415 | Session: ePoster Date: September 11- Time: Available from Presenter: Gavin |
Clinical Outcomes in | Karan R, Roy S, | LB1151 | Session: Latebreaker Date: September 25- Time: Available from Presenter: Radmila |
Treatment Satisfaction | Brochet B, | P1066 | Session: ePoster Date: September 11- Time: Available from Presenter: Bruno |
Initial Findings From a | Sabidó, M, Batech | P0470 | Session: ePoster Date: September 11- Time: Available from Presenter: Meritxell |
Characteristics of | Zeng F, Harty G, | P0846 | Session: ePoster Date: September 11- Time: Available from Presenter: Feng Zeng |
Characterization of | Zeng F, Harty G, | P0847 | Session: ePoster Date: September 11- Time: Available from Presenter: Feng Zeng |
CLASSIC-MS: Long- | Giovannoni G, Leist | LB1229 | Session: Latebreaker Date: September 25- Time: Available from Presenter: Thomas |
Age-related Efficacy of | Freedman M, Pardo | P0284 | Session: ePoster Date: September 11- Time: Available from Presenter: Mark |
Cladribine Tablets in | Miravelle A, Katz J, | P0310 | Session: ePoster Date: September 11- Time: Available from Presenter: Augusto |
Treatment-emergent | Oh J, Walker B, | P0411 | Session: ePoster Date: September 11- Time: Available from Presenter: Jiwon Oh |
Identification and | Cisternas MG, | P0967 | Session: ePoster Date: September 11- Time: Available from Presenter: Amy |
Real-world Patient-level | Kozma CM, Roberts | P1052 | Session: ePoster Date: September 11- Time: Available from Presenter: Chris |
Value-added Benefits of | Morgan K, Vernon | P1069 | Session: ePoster Date: September 11- Time: Available from Presenter: Kate Morgan |
Demonstrating the | Morgan K, Joseph | P1015 | Session: ePoster Date: September 11- Time: Available from Presenter: Kate |
Low Discontinuation | Oh J, Giacomini P, | P0880 | Session: ePoster Date: September 11- Time: Available from Presenter: Jiwon Oh |
Cladribine Tablets | Piasecka- | P0040 | Session: ePoster Date: September 11- Time: Available from Presenter: K. |
MS Disease-modifying | Ziemssen T, | 566 | Session: ePoster Date: September 11- Time: Available from Presenter: Tjalf |
Switching disease
| Saiz A, Aguera E, | P0401 | Session: ePoster Date: September 11- Time: Available from Presenter: Luis Brieva |
CLADQoL (CLADribine | Penner IK, Pul R, | P0849 | Session: ePoster Date: September 11- Time: Available from Presenter: Iris- |
Effects of Cladribine on | Eixarch H, Calvo- | P0330 | Session: ePoster Date: September 11- Time: Available from Presenter: Herena |
Real-world Experience
| Butzkueven H, | P0907 | Session: ePoster Date: September 11- Time: Available from Presenter: Helmut |
2-
| Aybar F, Marcora S, | P0270 | Session: ePoster Date: September 11- Time: Available from Presenter: Jorge |
Cladribine to Halt
| Lieberman D, | P0196 | Session: ePoster Date: September 11- Time: Available from Presenter: David |
Predicting Long-term | Sharmin S, Bovis F, | P0131 | Session: ePoster Date: September 11- Time: Available from Presenter: S Sharmin |
A Clinical Data | Forsberg L, | P0276 | Session: ePoster Date: September 11- Time: Available from Presenter: L Forsberg |
Impact of Cladribine | Raji A, Winkler G | P0586 | Session: ePoster Date: September 11- Time: Available from Presenter: A Raji |
Early Real-World Safety, | Bain J, Jones A, | P0319 | Session: ePoster Date: September 11- Time: Available from Presenter: J Bain |
Switching From | O'Neill DTD, | P0399 | Session: ePoster Date: September 11- Time: Available from Presenter: D O'Neill |
The Effect of Cladribine | Verma ND, Al- | P0406 | Session: ePoster Date: September 11- Time: Available from Presenter: Suzanne |
Rebif® (interferon beta-1a) Presentations | |||
A Systematic Review | Lopez-Leon S, Sabidó M, Turkson, | P0278 | Session: ePoster Date: September 11- Time: Available from Presenter: Meritxell |
Post-approval Safety of | Freedman M S, | P0370 | Session: ePoster Date: September 11- Time: Available from Presenter: Mark |
Effect of Neutralizing | Freedman MS, | P0323 | Session: ePoster Date: September 11- Time: Available from Presenter: Mark |
Baseline Serum | Kuhle J, Leppert D, | P0032 | Session: ePoster Date: September 11- Time: Available from Presenter: Sanjeev |
Effect of age on | Sabidó M, Allignol A | P0320 | Session: ePoster Date: September 11- Time: Available from Presenter: Patrick |
Comparing Infection- | Bove R, Kozma C, | P0451 | Session: ePoster Date: September 11- Time: Available from Presenter: Riley Bove |
Assessment of the | Hemelin F, Marie | P1095 | Session: ePoster Date: September 11- Time: Available from Presenter: Fanny |
Impact of Interferon- | Tokic M, Thiel S, | P1126 | Session: ePoster Date: September 11- Time: Available from Presenter: M Tokic |
Evobrutinib Presentations | |||
Clinical Relapse Rates | Montalban X, | P0197 | Session: ePoster Date: September 11- Time: Available from Presenter: Fernando |
Safety of the Bruton's | Montalban, X | P0235 | Session: ePoster Date: September 11- Time: Available from Presenter: Fernando |
Effect Of Evobrutinib, | Montalban X, Shaw
| P0070 | Session: ePoster Date: September 11- Time: Available from Presenter: Jamie |
Evobrutinib, a Highly | Torke S, Pretzsch | P0334 | Session: ePoster Date: September 11- Time: Available from Presenter: Sebastian |
Expression of Bruton's | Kebir H, Ceja G, | P0962 | Session: ePoster Date: September 11- Time: Available from Presenter: Kebir |
T-bet+ B-cell | Rijvers L, Melief MJ, | P0403 | Session: ePoster Date: September 11- Time: Available from Presenter: Liza |
The Bruton's Tyrosine | Kim S, Boschert U | P0404 | Session: ePoster Date: September 11- Time: Available from Presenter: Pavan |
The Validity and | Kamudoni P, | P1062 | Session: ePoster Date: September 11- Time: Available from Presenter: Paul |
The Interpretation and | Kamudoni P, Johns | P1061 | Session: ePoster Date: September 11- Time: Available from Presenter: Paul |
General MS Franchise | |||
Identifying Gaps in | Schmierer K, | P1100 | Session: ePoster Date: September 11- Time: Available from Presenter: Klaus |
An Investigation Into | Langdon D,
| P1006 | Session: ePoster Date: September 11- Time: Available from Presenter: Dawn |
Characterization of Age- | Zuroff LR, Li R, | P0952 | Session: ePoster Date: September 11- Time: Available from Presenter: LR Zuroff |
Treatment and Care | Freeman L, Lucas | P0176 | Session: ePoster Date: September 11- Time: Available from Presenter: Terrie |
About MAVENCLAD®
MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.
Because cladribine is cytotoxic, special handling and disposal instructions should be followed.
MAVENCLAD has been approved in 79 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
- Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy; evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis for patients with prior or increased risk of malignancy.
- MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm.
CONTRAINDICATIONS
- Current malignancy.
- Pregnancy, and women and men of reproductive potential who do not plan to use effective contraception during MAVENCLAD dosing and for 6 m after the last dose in each treatment course.
- Human immunodeficiency virus (HIV).
- Active chronic infections (e.g., hepatitis or tuberculosis).
- History of hypersensitivity to cladribine.
- Breastfeeding while taking MAVENCLAD and for 10 days after the last dose.
DOSING CONSIDERATIONS: After the completion of 2 treatment courses, do not administer additional MAVENCLAD during the next 2 years. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after completion of 2 treatment courses has not been studied.
ADDITIONAL WARNINGS AND PRECAUTIONS
- Lymphopenia: In clinical studies, 87% of MAVENCLAD-treated patients experienced lymphopenia. Concomitant use of MAVENCLAD with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects. Monitor lymphocyte counts before and during treatment, periodically thereafter, and when clinically indicated.
- Infections: Infections occurred in 49% of MAVENCLAD-treated patients compared to 44% of patients treated with placebo in clinical studies. The most frequent serious infections included herpes zoster and pyelonephritis. Single fatal cases of tuberculosis and fulminant hepatitis B were reported in the clinical program. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting MAVENCLAD. Screen patients for latent infections; consider delaying treatment until infection is fully controlled. Vaccinate patients antibody-negative to varicella zoster virus prior to treatment. Monitor for infections. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. In patients treated with parenteral cladribine for oncologic indications, cases of progressive multifocal leukoencephalopathy (PML) have been reported. No case of PML has been reported in clinical studies of cladribine in patients with MS.
- Hematologic Toxicity: Mild to moderate decreases in neutrophil counts, hemoglobin levels, and platelet counts were observed. Severe decreases in neutrophil counts were observed in 3.6% of MAVENCLAD-treated patients, compared to 2.8% of placebo patients. Obtain complete blood count (CBC) with differential including lymphocyte count before and during treatment, periodically thereafter, and when clinically indicated.
- Risk of Graft-versus-Host Disease With Blood Transfusions: Irradiation of cellular blood components is recommended.
- Liver Injury: Obtain liver function tests prior to treatment. Discontinue MAVENCLAD if significant injury is suspected.
- Hypersensitivity: In clinical studies, 11% of MAVENCLAD-treated patients had hypersensitivity reactions, compared to 7% of placebo patients. Serious hypersensitivity reactions occurred in 0.5% of MAVENCLAD-treated patients, compared to 0.1% of placebo patients. If a hypersensitivity reaction is suspected, discontinue treatment. Do not use MAVENCLAD in patients with a history of hypersensitivity to cladribine.
- Cardiac Failure: In clinical studies, one MAVENCLAD-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Cases of cardiac failure have also been reported with parenteral cladribine used for treatment indications other than multiple sclerosis.
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Avoid concomitant use of certain antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Please see the full Prescribing Information, including boxed WARNING for additional information.
About Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.
IMPORTANT SAFETY INFORMATION:
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.
Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.
Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury. Monitor liver function tests and patients for signs and symptoms of hepatic injury. Consider discontinuing Rebif if hepatic injury occurs.
Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.
In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.
Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.
Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.
The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.
Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal studies. Data from a large human population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent.
Please see the full Prescribing Information for additional information: https://www.emdserono.com/us-en/pi/rebif-pi.pdf
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
EMD Serono, Inc. and Multiple Sclerosis
For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.
About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com.
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