Patients with newly diagnosed glioblastoma and methylated MGMT gene promoter status did not live significantly longer when treated with cilengitide plus chemoradiotherapy
Darmstadt, Germany, 1-3-2013 — /europawire.eu/ — Merck Serono, a division of Merck, Darmstadt, Germany, announced today that the Phase III CENTRICa
trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). CENTRIC includes patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status. The trial was planned and is being conducted in partnership with the European Organisation for Research and Treatment of Cancer (EORTC). Detailed trial results will be submitted for presentation at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting and publication in a peer-reviewed journal.
Patient safety in CENTRIC was monitored frequently by an independent data
monitoring committee and no new or unexpected safety concerns were noted. In prior clinical studies, the most frequently reported adverse events the investigators considered to be attributed to cilengitide included nausea and fatigue.
CENTRIC is a randomized, controlled, multicenter, open-label Phase III trial. The trial evaluated the efficacy and safety of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients from 23 countries worldwide with newly diagnosed glioblastoma and methylated MGMT gene promoter status. Patients whose tumors have an unmethylated MGMT gene promoter status are currently being evaluated in the Phase II, randomized, open-label, multicenter COREb trial.
“These results illustrate how challenging this disease remains, and that thorough
clinical investigations like in this study are crucial before adopting new treatment strategies,” said the lead investigator and president of the EORTC Professor Roger Stupp, Head of Neuro-Oncology, Department of Neurosurgery, University of Lausanne Medical Center, Lausanne, Switzerland and newly appointed director of the Zurich University Cancer Center. “Nevertheless, the unique collaboration between academia and industry was key in establishing molecular tumor characterization towards personalized medicine. And it allows for investigation of mechanisms of disease, and identifying novel targets and combinations for the future. We remain committed to addressing the needs of patients suffering from this rare disease and will continue to investigate other treatment options.”
Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck
Serono, commented: “The results of CENTRIC are disappointing, especially for people who are fighting this devastating and difficult to treat cancer. Over the coming months, we intend to analyze the data sets and ensure appropriate public disclosure of key information that will serve future scientific research related to targeted therapies in oncology. For a complete picture, we will also evaluate the results of the currently ongoing Phase II CORE trial, which included only patients with an unmethylated MGMT gene promoter status. We remain committed to advancing our pipeline and developing new treatment options in oncology for patients with high medical need.”
a. CENTRIC: CilENgitide in combination with Temozolomide and Radiotherapy In newly diagnosed glioblastoma Phase III randomized Clinical trial
b. CORE: Cilengitide in patients with newly diagnOsed glioblastoma multifoRme and unmethylated MGMT genE promoter
About Cilengitide
Cilengitide is the first in a new class of investigational targeted anticancer therapies – the integrin inhibitors – to have reached Phase III clinical development. Cilengitide is thought to target certain integrins overexpressed or aberrantly expressed in many cancers that are involved in tumor cell growth and the formation of new tumor-related blood vessels in the tumor microenvironment.
Cilengitide is currently being investigated in glioblastoma – a very aggressive type of brain tumor – in a Phase III trial (CENTRIC) and in a Phase II trial (CORE). An additional Phase I/II trial is ongoing in nonsmall cell lung cancer (NSCLC). Further trials are being conducted by the U.S. National Cancer Institute (NCI). In the United States and Canada, cilengitide is being developed by EMD Serono, a subsidiary of Merck.
• The CENTRIC trial is a multicenter, randomized, controlled, open-label Phase III trial in patients with newly diagnosed glioblastoma and methylated MGMT gene promoter (M+) status. The study assessed the efficacy and safety of adding cilengitide to chemoradiotherapy (CRT; temozolomide [TMZ] and radiotherapy followed by TMZ), versus CRT alone. CENTRIC was planned and conducted in close partnership with the European Organisation for Research and Treatment of Cancer (EORTC).
• The CORE trial is a multicenter, randomized, controlled, open-label Phase II trial in patients with newly diagnosed glioblastoma and unmethylated MGMT gene promoter (M–) status. The study is assessing the safety and tolerability of two cilengitide dosing schedules added to CRT, versus that of CRT alone.
About MGMT Testing
The methylation status of methylguanine-DNA methyltransferase (MGMT) gene promoter is an important molecular factor in glioblastoma tumors. MGMT is thought to contribute to cellular DNA repair. Methylation of the gene promoter in the tumor tissue silences the expression of MGMT and has been found to be a
prognostic and potentially predictive marker for benefit from temozolomide treatment in patients with newly diagnosed glioblastoma.
Merck Serono is committed to the philosophy of personalized cancer care. The clinical trial program for cilengitide includes a companion diagnostic biomarker test, PredictMDx for Glioblastoma, produced by MDx Health, which identified the methylation status of the MGMT gene in patients. Patients whose tumors
had methylated MGMT gene promoter status were included in the CENTRIC trial. Patients with unmethylated MGMT gene promoter status are currently being evaluated in the Phase II open-label multicenter CORE trial.
About EORTC
The aims of the European Organisation for Research and Treatment of Cancer (EORTC; www.eortc.org ) are to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems, aiming at increasing survival but also patient quality of life. Extensive and comprehensive research in this wide field is beyond the means of individual European hospitals, and can best be accomplished through the multidisciplinary multinational efforts of basic
scientists and clinicians.
Over the past few years, numerous innovative agents have been discovered as a result of tremendous developments in the understanding of the molecular basis of cancer. Further clinical progress in cancer treatment will be accomplished mainly through the conduct of translational research projects, efficient drug
development and the execution of large, prospective, randomized, multicenter cancer clinical trials. The EORTC promotes multidisciplinary cancer research in Europe and is linked to other leading biomedical research organizations around the world.
The aim of the EORTC is to facilitate the passage of experimental discoveries into state-of-the-art treatments by keeping to a minimum the time lapse between the discovery of new anti-cancer agents and the implementation of their therapeutic benefit for patients with cancer.
The ultimate goal of the EORTC is to improve the standards of cancer treatment and care, and personalized therapy. Innovative drugs and new regimens are being evaluated, and strategies of available drug treatments, surgery and radiotherapy being optimized and combined.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology and rheumatology.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of €10.3 billion in 2011, a history that began in 1668, and a future shaped by approx. 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
For more information, please visit www.merckserono.com or www.merckgroup.com.
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- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
- Editor's pick archive....
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP