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Merck Serono to Release New Pipeline Data at ASCO 2014 from Early-Stage Investigational Compounds in Difficult-to-Treat Cancers

Geschrieben am 29-05-2014

Darmstadt, Germany (ots/PRNewswire) -

ASCO abstract #: Anti-PD-L1: 3064; c-Met: 2521, TPS4151, TPS8121;
tecemotide: TPS3658, TPS7608; TH-302: 8534, 2029; further pipeline:
3551, TPS9107, 5030, 2050, e13552


- Robust pipeline reflects commitment to innovation in oncology and
immuno-oncology
- Data from nine Merck Serono pipeline products across oncology and
immuno-oncology to be presented, including anti-PD-L1, c-Met inhibitor and TH-302


Merck Serono, the biopharmaceutical division of Merck, today
announced that new data from nine investigational compounds from the
company's oncology and immuno-oncology pipeline will be included at
the 50th Annual Meeting of the American Society of Clinical Oncology
(ASCO) held in Chicago, Illinois, U.S., from May 30 to June 3, 2014.
These data represent Merck's commitment to research and development
in oncology and immuno-oncology, and to improving patient outcomes
through internally developed compounds, as well as those acquired and
in development with the company's strategic partners.

"We are excited to present the most recent data from our oncology
development candidates, including Phase I data on our promising
anti-PD-L1 monoclonal antibody - a key milestone which highlights the
potential of our immuno-oncology pipeline," said Belen Garijo,
President and CEO of Merck Serono. "Through the spectrum of our
efforts, from discovery through development, we keep the patients at
the center of our activities, with the goal of transforming
innovative research into differentiated medicines that are tailored
to their needs."

Merck Serono's oncology and immuno-oncology pipeline includes more
than 22 programs in early- and late-stage development, targeting a
variety of difficult-to-treat cancers. Notable data presented at this
year's ASCO include preliminary data from the investigational
anti-PD-L1 monoclonal antibody (MSB0010718C) and the investigational
c-Met inhibitor (MSC2156119J), both in advanced solid malignancies,
and TH-302, an investigational hypoxia-activated prodrug, in multiple
myeloma and glioblastoma.

Abstracts are currently available on the ASCO website
[http://abstracts.asco.org ].

Notes to Editors

Abstracts related to Merck Serono's oncology and immuno-oncology
pipeline include:


Anti-PD-L1

Title: Phase I open-label, multiple ascending dose trial of MSB0010718C, an anti-PD-L1
monoclonal antibody, in advanced solid malignancies.
Lead author: CR Heery
Abstract #: 3064
Presentation date/time (CDT): Jun 1, 08:00-11:45
Session: General Poster Session: Developmental Therapeutics - Immunotherapy
Room/Details: S Hall A2 (Poster Board: 131)

c-Met inhibitor

Title: Results of the first-in-human phase I trial assessing MSC2156119J (EMD 1214063),
an oral selective c-Met inhibitor, in patients (pts) with advanced solid tumors.
Lead author: GS Falchook
Abstract #: 2521
Presentation date/time (CDT): Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45
Session: Poster Highlights Session: Developmental Therapeutics: Clinical Pharmacology
and Experimental Therapeutics
Room/Details: Time 1: E354b Time 2: E Arie Crown Theater (Poster Board: 35)

Title: A multicenter, randomized, phase Ib/II trial of the oral c-Met inhibitor
MSC2156119J as monotherapy versus sorafenib in Asian patients with MET-positive (MET+)
advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function.
Lead author: S Qin
AbstractAb#: TPS4151
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: Gastrointestinal (Noncolorectal) Cancer
Room/Details: S Hall A2 (Poster Board: 234B)

Title: Phase I/II multicenter, randomized, open-label trial of the c-Met inhibitor
MSC2156119J and gefitinib versus chemotherapy as second-line treatment in patients
with MET-positive (MET+), locally advanced, or metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor mutation (EGFRm+) and progression on gefitinib.
Lead author: Y-L Wu
Abstract #: TPS8121
Presentation date/time (CDT): May 31, 13:15-17:00
Session: General Poster Session: Lung Cancer - Non-small Cell Metastatic
Room/Details: S Hall A2 (Poster Board: 300B)

Tecemotide

Title: A randomized, double-blind, placebo-controlled, multicenter, binational, phase
II trial of immunotherapy with L-BLP25 (tecemotide) in patients with colorectal
carcinoma following R0/R1 hepatic metastasectomy. (Investigator-sponsored trial).
Lead author: S Kasper
Abstract #: TPS3658
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: Gastrointestinal (Colorectal) Cancer
Room/Details: S Hall A2 (Poster Board: 116A)

Title: START2: Tecemotide in unresectable stage III NSCLC after first-line concurrent
chemoradiotherapy.
Lead author: S Ramalingam
Abstract #: TPS7608
Presentation date/time (CDT): May 31, 13:15-17:00
Session: General Poster Session: Lung Cancer - Non-small Cell Local-regional/Small
Cell/Other Thoracic Cancers
Room/Details: S Hall A2 (Poster Board: 216A)

TH-302

Title: Preliminary safety and efficacy of TH-302, an investigational hypoxia-targeted
drug, and dexamethasone (dex) in patients (pts) with relapsed/refractory multiple
myeloma (RR MM).
Lead author: J Laubach
Abstract #: 8534
Presentation date/time (CDT):
Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45.
Session: Poster Highlights Session: Lymphoma and Plasma Cell Disorders
Room/ Details: Time 1: S405. Time 2: S406 (Poster Board: 14)

Title: Phase 1/2 study of investigational hypoxia-targeted drug, TH-302, and
bevacizumab (bev) in recurrent glioblastoma (GBM) following bev failure.
(Investigator-sponsored trial).
Lead author: AJ Brenner
Abstract #: 2029
Presentation date/time (CDT): Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45.
Session: Poster Highlights Session: Central Nervous System Tumors
Room/Details: Time: 1 E354b. Time 2: E450 (Poster Board: 20)

Additional Pipeline Projects: Oncology and Immuno-Oncology

Title: Phase 1 study of biweekly (Q2W) anti-EGFR monoclonal antibody (mAb) mixture
Sym004 in patients (pts) with metastatic colorectal cancer (mCRC) resistant to
previous anti-EGFR treatment.
Lead author: G Argiles
Abstract #: 3551
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: GI (Colorectal) Cancer
Room/ Details: S Hall A2 (Poster Board: 14)

Title: Targeted modified IL-2 (NHS-IL2, MSB0010445) combined with stereotactic body
radiation in advanced melanoma patients after progression on ipilimumab: Assessment of
safety, clinical, and biologic activity in a phase 2a study.
Lead author: H Kaufman
Abstract #: TPS9107
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: Melanoma/Skin Cancers
Room/Details: S Hall A2 (Poster Board: 308B)

Title: Primary outcomes of the placebo-controlled phase 2 study PERSEUS (NCT01360840)
investigating two dose regimens of abituzumab (DI17E6, EMD 525797) in the treatment of
chemotherapy-naive patients (pts) with asymptomatic or mildly symptomatic metastatic
castration-resistant prostate cancer (mCRPC).
Lead author: M Hussain
Abstract #: 5030
Presentation date/time (CDT): May 31, 13:15-16:15
Session: Poster Highlights Session: Genitourinary (Prostate) Cancer
Room/Details: E354b (Poster Board: 45)

Title: Radiotherapy (RT), temozolomide (TMZ), procarbazine (PCB), and the integrin
inhibitor cilengitide in patients (pts) with glioblastoma (GBM) without methylation of
the MGMT gene promoter (ExCentric): Results of an Australian phase II clinical trial.
Lead author: M Khasraw
Abstract #: 2050
Presentation date/time (CDT): May 31, 13:15-17:00
Session: General Poster Session: Central Nervous System Tumors.
Room/Details: S Hall A2 (Poster Board: 15)

Title: Absolute bioavailability, mass balance, elimination route, and metabolite
profile of the selective oral MEK1/2 inhibitor pimasertib in cancer patients.
Lead author: G Massimini
Abstract #: e13552
Presentation date/time (CDT): Abstract only


Tecemotide, TH-302 and all early-stage products are currently
under clinical investigation and have not been approved for use in
the U.S., Europe, Canada, or elsewhere. All investigational products
have not yet been proven to be either safe or effective and any
claims of safety and effectiveness can be made only after regulatory
review of the data and approval of the labeled claims.

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 neurology, oncology,
immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
http://www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

Merck is a leading company for innovative and top-quality
high-tech products in the pharmaceutical and chemical sectors. With
its four divisions Merck Serono, Consumer Health, Performance
Materials and Merck Millipore, Merck generated total revenues of EUR
11.1 billion in 2013. Around 38,000 Merck employees work in 66
countries to improve the quality of life for patients, to further the
success of our customers and to help meet global challenges.

Merck is the world's oldest pharmaceutical and chemical company -
since 1668, the company has stood for innovation, business success
and responsible entrepreneurship. Holding an approximately 70%
interest, the founding family remains the majority owner of the
company to this day.

Merck, Darmstadt, Germany is holding the global rights to the
Merck name and brand. The only exceptions are Canada and the United
States, where the company is known as EMD.

ots Originaltext: Merck Serono GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Cornelia Bartels, Phone +49-6151-72-3890


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