Bringing Innovation to Patients: Merck Presents New Advances at ASCO 2016

PR64480

DARMSTADT, Germany, May 19, 2016 /PRNewswire=KYODO JBN/ --

Not intended for UK- or US-based media   

ASCO Abstract #

Avelumab: 4009, TPS4134, TPS4135, 9036, TPS9105, 3055, TPS3106, 8503, 4514,

4516, 5533, TPS5600, TPS4580, 9508; tepotinib: 4072

・ Abstracts featuring Merck compounds span a broad range of cancers, with an

emphasis on those which are difficult-to-treat and represent significant unmet

patient need     

・Avelumab data in seven different cancers from rapidly accelerating JAVELIN

clinical program to be presented   

Merck, a leading science and technology company, announced that this year's

Annual Meeting of the American Society of Clinical Oncology (ASCO; June 3-7,

2016, Chicago, IL, U.S.) will feature research on Merck compounds across a

broad range of cancers. These reports, which focus on cancers with significant

unmet patient need, will inform and advance scientific knowledge within the

oncology community. This includes data on avelumab*, Merck's high priority,

late-stage investigational immuno-therapy, that is being developed in

collaboration with Pfizer.

     (Logo: http://photos.prnewswire.com/prnh/20151207/293543LOGO )

"We have a clear and focused commitment to accelerate oncology innovation and

transform the way cancer is treated, both by leveraging our internal expertise

and capabilities, and through our collaborations," said Luciano Rossetti,

Executive Vice President, Head of Global Research & Development at the

biopharma business of Merck. "Avelumab is an example of this strategy coming to

life, as it was originally discovered by Merck and is being co-developed with

Pfizer. More broadly, we will be presenting data across multiple tumor types at

ASCO as we continue to advance our oncology and immuno-oncology pipeline."

Collaborating to bring innovation to cancer patients   

Merck and Pfizer are presenting avelumab data at this year's congress that

reflect the significant progress this alliance is making. This includes results

from the pivotal, Phase II metastatic Merkel cell carcinoma trial which, taken

together with data from other challenging tumors being evaluated in the JAVELIN

clinical development program, supports efficacy and a favorable safety profile

for avelumab. Avelumab, an investigational, fully human, anti-programmed

death-ligand 1 (PD-L1) monoclonal antibody, has a dual mechanism of action that

is believed to enable the immune system to find and attack cancer cells.

Avelumab's clinical program, one of the largest immuno-oncology development

programs, now includes approximately 2,200 patients across more than 15 tumor

types. Together, the two companies have initiated 30 ongoing monotherapy or

combination therapy programs with avelumab, including nine pivotal studies.

Innovation: treatment and beyond

Erbitux(R) (cetuximab) and precision medicine remain a strategic priority for

Merck. As a cornerstone of treatment in RAS wild-type mCRC and SCCHN, Merck is

committed to exploring Erbitux as an 'anchor' treatment in combination with

immuno-therapies in these indications. Erbitux also continues to captivate the

interest of leading researchers and the medical community with more than 30

abstracts at ASCO, the majority from investigator-led studies.

Merck aims to improve patients' experiences along their treatment journey by

helping patients and physicians to make faster treatment decisions. Merck is

the first pharmaceutical company to collaborate with multiple diagnostic

companies to co-develop and commercialize innovative liquid biopsy RAS

biomarker tests to determine which patients with mCRC would benefit from

treatment with Erbitux. At ASCO, Merck's partner Sysmex Inostics will be

presenting new data demonstrating the value of the co-developed and

commercialized liquid biopsy test, which received CE mark approval earlier this

year.

Truly innovative pipeline

Following Merck's strategic reassessment of its portfolio, there is significant

potential with later-stage priority programs and Merck's truly innovative early

pipeline. Six out of seven of the current pipeline products in Phases I-III

were discovered in Merck's labs.

Data will be presented on another of these Merck-discovered compounds,

tepotinib**, an investigational, highly selective, small molecule inhibitor of

the c-Met receptor tyrosine kinase. The ASCO presentation will report on

tepotinib's clinical activity and tolerability in Asian patients with advanced

hepatocellular carcinoma, a cancer in which there is a considerable need for

new treatment options.

Through Merck's Translational Innovation Platforms in oncology and

immuno-oncology, the company is developing differentiated therapeutic drugs

targeting distinct cancer hallmarks and multiple immune-system-mediated

mechanisms. These include, among others, DNA repair, antibody drug conjugates,

oncogenes, tumor antigens, T-cell therapies, and targeted cytokines and

chemokines.

*Avelumab is the proposed nonproprietary name for the anti-PD-L1 mAb (also

known as MSB0010718C).

**Tepotinib is the proposed nonproprietary name for the c-Met kinase inhibitor

(also known as MSC2156119J).

Avelumab and tepotinib are under clinical investigation and have not been

proven to be safe and effective. There is no guarantee any product will be

approved in the sought-after indication by any health authority worldwide.

Notes to Editors   

Accepted Merck-supported abstracts are listed below. In addition, a number of

investigator-sponsored studies have been accepted, including several related to

Erbitux and avelumab (not listed).

Avelumab   

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or

gastroesophageal junction cancer from the JAVELIN Solid Tumor Phase Ib trial:

analysis of safety, clinical activity

Lead Author: C Chung

Abstract #: 4009

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer

Room/Details: Hall A (Poster Board: 1)

Title: Maintenance therapy with avelumab (MSB0010718C; anti-PD-L1) vs

continuation of first-line chemotherapy in patients with unresectable, locally

advanced or metastatic gastric cancer: the Phase III JAVELIN Gastric 100 trial

Lead Author: M Moehler

Abstract #: TPS4134

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer

Room/Details: Hall A (Poster Board: 124b)

Title: Avelumab (MSB0010718C; anti-PD-L1) + best supportive care (BSC) vs BSC ±

chemotherapy as third-line treatment for patients with unresectable, recurrent,

or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial

Lead Author: Y-J Bang

Abstract #: TPS4135

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer

Room/Details: Hall A (Poster Board: 125a)

Title: Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for

patients with advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial:

safety, clinical activity, and PD-L1 expression

Lead Author: C Verschraegen

Abstract #: 9036

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Lung Cancer-Non-Small Cell Metastatic

Room/Details: Hall A (Poster Board: 359)

Title: Avelumab (MSB0010718C; anti-PD-L1) vs platinum-based doublet as

first-line treatment for metastatic or recurrent PD-L1-positive non-smallcell

lung cancer: the Phase III JAVELIN Lung 100 trial

Lead Author: M Reck

Abstract #: TPS9105

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Lung Cancer-Non-Small Cell Metastatic

Room/Details: Hall A (Poster Board: 425a)

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer:

safety data from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor

trial

Lead Author: K Kelly

Abstract #: 3055

Presentation Date/Time (CDT): June 5 08:00-11:30

Session: Poster Session: Developmental Therapeutics-Immunotherapy

Room/Details: Hall A (Poster Board: 377)

Title: Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer

immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN

Medley study

Lead Author: A Ribas

Abstract #: TPS3106

Presentation Date/Time (CDT): June 5 08:00-11:30

Session: Poster Session: Developmental Therapeutics-Immunotherapy

Room/Details: Hall A (Poster Board: 422b)

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced

unresectable mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety,

clinical activity, and PD-L1 expression

Lead Author: R Hassan

Abstract #: 8503

Presentation Date/Time (CDT): June 5 08:00-11:05

Session: Oral Abstract Session: Lung Cancer-Non-Small Cell Local-Regional/Small

Cell/Other Thoracic Cancers

Room/Details: Arie Crown Theater

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic

urothelial carcinoma from the JAVELIN Solid Tumor Phase Ib trial: analysis of

safety, clinical activity, and PD-L1 expression

Lead Author: A Apolo

Abstract #: 4514

Presentation Date/Time (CDT): June 6 13:00-16:30

Session: Poster Session: Genitourinary (Nonprostate) Cancer

Room/Details: Hall A (Poster Board: A137)

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced

adrenocortical carcinoma from the JAVELIN Solid Tumor Phase Ib trial: safety

and clinical activity

Lead Author: C Le Tourneau

Abstract #: 4516

Presentation Date/Time (CDT): June 6 13:00-16:30

Session: Poster Session: Genitourinary (Nonprostate) Cancer

Room/Details: Hall A (Poster Board: 138)

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory

ovarian cancer from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical

activity

Lead Author: M Disis

Abstract #: 5533

Presentation Date/Time (CDT): June 6 13:00-16:30

Session: Poster Session: Gynecologic Cancer

Room/Details: Hall A (Poster Board: 356)

Title: Avelumab (MSB0010718C; anti-PD-L1) ± pegylated liposomal doxorubicin vs

pegylated liposomal doxorubicin alone in patients with

platinum-resistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200

trial

Lead Author: E Pujade-Lauraine

Abstract #: TPS5600

Presentation Date/Time (CDT): June 6 13:00-16:30

Session: Poster Session: Gynecologic Cancer

Room/Details: Hall A (Poster Board: 421b)

Title: Avelumab (MSB0010718C; anti-PD-L1) in combination with axitinib as

first-line treatment for patients with advanced renal cell carcinoma

Lead Author: J Larkin

Abstract #: TPS4580

Presentation Date/Time (CDT): June 6 13:00-16:30

Session: Poster Session: Genitourinary (Nonprostate) Cancer

Room/Details: Hall A (Poster Board: 199a)

Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel

cell carcinoma previously treated with chemotherapy: results of the Phase II

JAVELIN Merkel 200 trial

Lead Author: H Kaufman

Abstract #: 9508

Presentation Date/Time (CDT): June 6 13:15-16:15

Session: Oral Abstract Session: Melanoma/Skin Cancers

Room/Details: Arie Crown Theater

Tepotinib   

Title: Tolerability and activity of tepotinib in Asian patients with advanced

hepatocellular carcinoma (HCC)

Lead Author: S Qin

Abstract #: 4072

Presentation Date/Time (CDT): June 4 08:00-11:30

Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer

Room/Details: Hall A (Poster Board: 64)

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go tohttp://www.merckgroup.com/subscribe

to register online, change your selection or discontinue this service.

About Avelumab    

Avelumab (also known as MSB0010718C) is an investigational fully human

anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab

is thought to enable the activation of T-cells and the adaptive immune system.

By retaining a native Fc-region, avelumab is thought to potentially engage the

innate immune system and induce antibody-dependent cell-mediated cytotoxicity

(ADCC). In November 2014, Merck and Pfizer announced a strategic alliance to

co-develop and co-commercialize avelumab.

About Erbitux   

Erbitux(R) is a highly active IgG1 monoclonal antibody targeting the epidermal

growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of

Erbitux is distinct from standard non-selective chemotherapy treatments in that

it specifically targets and binds to the EGFR. This binding inhibits the

activation of the receptor and the subsequent signal-transduction pathway,

which results in reducing both the invasion of normal tissues by tumor cells

and the spread of tumors to new sites. It is also believed to inhibit the

ability of tumor cells to repair the damage caused by chemotherapy and

radiotherapy and to inhibit the formation of new blood vessels inside tumors,

which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash

that seems to be correlated with a good response to therapy. In approximately

5% of patients, hypersensitivity reactions may occur during treatment with

Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 90 countries

world-wide for the treatment of colorectal cancer and for the treatment of

squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right

to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned

subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment

to the advancement of oncology treatment and is currently investigating novel

therapies in highly targeted areas.

About Tepotinib   

Tepotinib (also known as MSC2156119J) is an investigational small-molecule

inhibitor of the c-Met receptor tyrosine kinase capable of inhibiting both

hepatocyte growth factor-dependent and -independent c-Met activation in low

nanomolar concentrations. Alterations of the c-Met signaling pathway are found

in various cancer types and correlate with aggressive tumor behavior and poor

clinical prognosis. Tepotinib is currently under evaluation in Phase I/II

trials.

About Merck   

Merck is a leading science and technology company in healthcare, life science

and performance materials. Around 50,000 employees work to further develop

technologies that improve and enhance life - from biopharmaceutical therapies

to treat cancer or multiple sclerosis, cutting-edge systems for scientific

research and production, to liquid crystals for smartphones and LCD

televisions. In 2015, Merck generated sales of Euros 12.85 billion in 66

countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical

company. The founding family remains the majority owner of the publicly listed

corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck

name and brand. The only exceptions are the United States and Canada, where the

company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Your Contact: Gangolf Schrimpf: +49-6151-72-9591

Source: Merck