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EMD Serono: Phase III Trial of Cilengitide Did Not Meet Primary Endpoint in Patients With Newly Diagnosed Glioblastoma



  EMD Serono: Phase III Trial of Cilengitide Did Not Meet Primary Endpoint in
  Patients With Newly Diagnosed Glioblastoma

  * Patients with newly diagnosed glioblastoma and methylated MGMT gene
    promoter status did not live significantly longer when treated with
    cilengitide plus chemoradiotherapy

Business Wire

ROCKLAND, Mass. -- February 25, 2013

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced
today that the Phase III CENTRIC^a 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
O^6-methylguanine-DNA methyltransferase (MGMT) gene promoter status. The trial
was planned and is being conducted in partnership with the European
Organization 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 CORE^b 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, a division of Merck KGaA, Darmstadt, Germany 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 over-expressed
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 non-small 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 EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader
in the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people's lives. The company
has strong market positions in neurodegenerative diseases, endocrinology and
in reproductive health. In addition, EMD Serono is growing its expertise and
presence in the area of oncology, with more than 15 projects currently in
development. With a clear focus on the patient and a leadership presence in
the biopharmaceutical industry, EMD Serono’s US footprint continues to grow,
with approximately 1,000 employees around the country and fully integrated
commercial, clinical and research operations in the company’s home state of
Massachusetts.

For more information, please visit www.emdserono.com.

About Merck KGaA

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.

###

Contact:

For EMD Serono
Erin-Marie Beals
Phone 781-681-2850
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