Merck Healthcare

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

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.

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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.

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