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

PR56887

DARMSTADT, Germany, May 29. 2014 /PRN=KYODO JBN/--

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 Bele;n 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) T

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: S Hall A2 (Poster Board: 131)

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.

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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.

SOURCE: Merck Serono