Merck: Driving Innovation in Cancer Care at ESMO 2017 With New Data in Hard-to-Treat Cancers

PR69847

DARMSTADT, Germany, August 31, 2017 /PRNewswire=KYODO JBN/ --

- Not intended for U.K. or U.S. based media

ESMO 2017 abstract #

Erbitux®: 576P, 593P, 1068P, 1579P; avelumab: 1227P, 913P, 1377TiP, 882P, 856P;

M6620 (ATR inhibitor): 242PD; M2698 (dual p70S6K/Akt inhibitor): 370PD, 393P;

tepotinib (c-Met kinase inhibitor): 701P

Data to showcase Merck's strong and diverse pipeline ranging from

immuno-oncology to DNA damage response

Avelumab data validate potential in hard-to-treat cancers and highlight

progress of the JAVELIN clinical development program

First stand-alone data in mTNBC for ATR inhibitor (M6620) from Merck's

comprehensive portfolio in DNA damage response  

Merck, a leading science and technology company, today announced it will

present data for a number of tumor types across its rapidly evolving pipeline.

A total of 23 abstracts, representing five therapeutic agents, will highlight

the company's expanding scientific expertise at this year's European Society

for Medical Oncology congress (ESMO 2017; September 8-12, Madrid, Spain).

Data to be presented include continued reinforcement of the role of established

brand Erbitux® (cetuximab) as a standard of care therapy, with quality of life

(QoL) data in colorectal cancer (CRC) and real-world data in both CRC and

squamous cell carcinoma of the head and neck (SCCHN); updated efficacy and

safety data for avelumab in metastatic Merkel cell carcinoma (mMCC) and

urothelial carcinoma (UC) among other cancers; and new data and updates from

Merck's rapidly evolving pipeline, including first stand-alone data in

metastatic triple negative breast cancer (mTNBC) from potential first-in-class

ataxia telangiectasia and Rad3-related protein (ATR) inhibitor M6620* (also

known as VX-970).

"The Merck Oncology Franchise has had a momentous year, particularly with the

positive regulatory milestones achieved for avelumab. The story continues to

evolve at ESMO 2017 from our legacy with Erbitux to our diverse and robust

pipeline which has potential novel molecules that could become new standards of

care," said Luciano Rossetti, Executive Vice President, Global Head of Research

& Development at the biopharma business of Merck. "The data reinforce Merck's

commitment to pursuing approaches that will bring important benefits to

patients and transform the way cancer is treated."

Merck's innovative approach and strategic collaborations in oncology are

exemplified through the ongoing partnership with Pfizer, and the significant

progress of avelumab. Granted two accelerated approvals** by the U.S. Food and

Drug Administration (FDA) this year, more recently the Committee for Medicinal

Products for Human Use (CHMP) of the European Medicines Agency (EMA) has

adopted a positive opinion recommending the approval of avelumab as monotherapy

for the treatment of adult patients with mMCC. ESMO 2017 includes new data for

avelumab in the treatment of mMCC, a rare and aggressive skin cancer, and

12-month follow-up data in pre-treated patients with locally advanced or

metastatic UC. The progress of the broader JAVELIN clinical development program

will also be highlighted, with updated data in hard-to-treat tumors such as

metastatic adrenocortical carcinoma (mACC).

The addition of the recently acquired Vertex DNA damage response (DDR)

portfolio to its own in-house DDR platform has positioned Merck as one of the

key players in the DDR field. The company's broad DDR portfolio includes

inhibitors for enzymes of major DDR pathways, such as ATR, DNA-PK and ATM. At

ESMO 2017, first data will be presented for ATR inhibitor M6620 in metastatic

triple-negative breast cancer (mTNBC). M6620 is currently being investigated in

several ongoing Phase I trials across a variety of tumor types.

Other pipeline updates will include data on the potential first-in-class dual

p70S6K/Atk inhibitor M2698*; and tepotinib***, a highly selective c-Met kinase

inhibitor, in patients with advanced hepatocellular carcinoma (HCC).

Product related information contained herein is subject to local product

approval and can therefore vary from country to country. For information

relevant to your country, please check in with local regulatory authorities.

*M6620, M2698 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.

***Tepotinib is the proposed International Non-proprietary Name (INN) for the

c-Met kinase inhibitor (also known as MSC2156119J).

Notes to editors

Accepted Merck-supported key abstracts at ESMO 2017 are listed below. In

addition, a number of abstracts with data from investigator-sponsored studies

have been accepted, including abstracts related to Erbitux (not listed).

   

                                                 Presentation

                                                 Date / Time

    Title              Lead Author   Abstract #  (CEST)          Location

    Avelumab

    Poster sessions

    JAVELIN Lung 100:

    updated design of

    a phase 3 trial of

    avelumab vs

    platinum doublet

    chemotherapy as

    first-line (1L)

    treatment for

    metastatic or                                

    recurrent PD-L1+

    non-small-cell                                

    lung cancer                                  September 9

    (NSCLC)            Reck M.       1377TiP     13:15 - 14:15   Hall 8

    

    JAVELIN MERKEL

    200: Avelumab

    treatment in

    chemotherapy-naïve                           

    patients with

    metastatic Merkel

    cell carcinoma                               September 10

    (mMCC).            D'Angelo S.P. 1227P       13:15-14:15     Hall 8

    

    Avelumab in

    patients with

    metastatic

    adrenocortical                               

    carcinoma (mACC):

    results from the

    JAVELIN Solid      Le Tourneau               September 10

    Tumor trial        C.            913P        13:15-14:15     Hall 8

    

    Potential impact

    of

    avelumab+axitinib

    (A+Ax) on tumor

    size (TS) compared

    with historical

    data of sunitinib                            

    (S) as evaluated

    by a modeling and

    simulation (MS)                              September 10

    approach           Zheng J.      882P        13:15-14:15     Hall 8

    

    Avelumab treatment

    of metastatic

    urothelial

    carcinoma (mUC) in

    the phase 1b

    JAVELIN Solid

    Tumor study:

    updated analysis

    with greater than

    or equal to6

    months of

    follow-up in all                              September 10

    patients            Apolo A.B.    856P        13:15-14:15     Hall 8

                                                 Presentation

                                                 date/time

    Title              Lead author   Abstract #  (CEST)          Location

    M6620 (VX-970)

    Poster session

    Initial results of

    a phase 1 dose

    expansion cohort

    of M6620 (VX-970),

    a first-in-class

    ATR inhibitor, in

    combination with

    cisplatin (Cis) in

    patients (pts)                                               

    with metastatic                                      

    triple-negative

    breast cancer

    (mTNBC)                                       September 10   Sevilla

    (NCT02157792)      Telli M.L.     242PD       09:15 - 10:45  auditorium

                      

                                                 Presentation

                                                 date/time

    Title              Lead author   Abstract #  (CEST)          Location

    M2698

    Poster session

                                                  

    Phase I dose

    escalation study

    of M2698, a                                  

    p70S6K/AKT

    inhibitor, in

    patients with      Tsimberidou               September 9     Alicante

    advanced cancer    A.M.          370PD       16:30-18:00     auditorium

    Pharmacodynamic

    (PD) biomarkers

    for the p70S6K/Akt

    inhibitor, M2698:

    translation from                             

    animal to human

    and its relevance

    for dosing                                   September 11

    rationale          Xiong W.      393P        13:15-14:15     Hall 8

    

                                                 Presentation

                                                 date/time

    Title              Lead author   Abstract #  (CEST)          Location

    Erbitux(R):

    Poster session

    Biomarker testing

    practices in the

    SECURE

    (proSpective

    obsErvational

    clinical practiCe

    stUdy in the

    first-line                                  

    management of

    metastatic

    colorectal cancer                           

    [mCRC] with                                     

    eRbitux in

    combination with

    chemothErapy)      Aravantinos             September 9

    study              G.            576P      13:15-14:15     Hall 8

    Quality of life

    (QoL) analyses in

    patients with RAS

    wild-type (wt)

    metastatic

    colorectal cancer

    (mCRC) treated

    with first-line                             

    FOLFOX-4 plus or

    minus cetuximab in

    the phase 3 TAILOR                          September 9

    trial              Liu T.        593P       13:15-14:15    Hall 8

    ENCORE: a phase 4

    observational

    study of cetuximab

    and platinum-based

    therapy (PBT) for

    the first-line

    treatment of

    patients with

    recurrent/metastat                          

    ic squamous cell

    carcinoma of the

    head and neck (R/M Le Tourneau              September 10

    SCCHN)             C.            1068P      13:15-14:15    Hall 8

    A survey of

    patient acceptance                          

    of skin toxicities

    from

    cetuximab-based                             September 10

    therapy            Tischer B.    1579P      13:15-14:15    Hall 8

    

                                               Presentation

                                               date/time

    Title             Lead author  Abstract #  (CEST)          Location

    Tepotinib

    Poster session

                                               

    Final data from a

    phase Ib trial of                          

    tepotinib in Asian                         

    patients with

    advanced

    hepatocellular                             September 9

    carcinoma (HCC)   Qin S.       701P        13:15-14:15     Hall 8

                                                Presentation

                                                date/time

    Title              Lead author  Abstract #  (CEST)         Location

    Anti-PD-L1/TGF-β

    trap pathways

    Poster session

    Analysis of

    programmed

    death-ligand 1

    (PD-L1)

    expression,

    transforming

    growth factor

    (TGF)-beta gene

    expression

    signatures (GES)                          

    and

    tumor-infiltrating

    immune cells (IC)

    in hepatocellular                 

    carcinoma (HCC):

    rationale for

    targeting PD-L1-                          September 11

    and TGF-beta        Zhang Y.    1645P     13:15-14:15       Hall 8

About avelumab

Avelumab is a human antibody specific for a protein called PD-L1, or programmed

death ligand-1. Avelumab is designed to potentially engage both the adaptive

and innate immune systems. By binding to PD-L1, avelumab is thought to prevent

tumor cells from using PD-L1 for protection against white blood cells, such as

T-cells, exposing them to anti-tumor responses. Avelumab has been shown to

induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In

November 2014, Merck and Pfizer announced a strategic alliance to co-develop

and co-commercialize avelumab.

**Indications in the US

The U.S. Food and Drug Administration (FDA) granted accelerated approval for

avelumab (BAVENCIO®) for the treatment of (i) metastatic Merkel cell carcinoma

(mMCC) in adults and pediatric patients 12 years and older and (ii) patients

with locally advanced or metastatic urothelial carcinoma (UC) who have disease

progression during or following platinum-containing chemotherapy, or who have

disease progression within 12 months of neoadjuvant or adjuvant treatment with

platinum-containing chemotherapy. These indications are approved under

accelerated approval based on tumor response rate and duration of response.

Continued approval for these indications may be contingent upon verification

and description of clinical benefit in confirmatory trials. Avelumab is not

approved for any indication in any market outside the U.S.

Important Safety Information  

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated

adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies,

nephritis and renal dysfunction and other adverse reactions), infusion-related

reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients

treated with avelumab for mMCC and patients with locally advanced or metastatic

UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related

reaction, peripheral edema, decreased appetite/hypophagia, urinary tract

infection and rash.

About Erbitux® (cetuximab)  

Erbitux® 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. Erbitux also

targets cytotoxic immune effector cells towards EGFR expressing tumor cells

(antibody dependent cell-mediated cytotoxicity, ADCC).

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

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 RAS wild-type metastatic colorectal cancer and

for the treatment of squamous cell carcinoma of the head and neck (SCCHN).

Merck licensed the right to market Erbitux, a registered trademark of ImClone

LLC, outside the U.S. and Canada from ImClone LLC, a wholly-owned subsidiary of

Eli Lilly and Company, in 1998.

About M6620

Also known as VX-970, M6620 is an investigational small-molecule inhibitor of

ataxia telangiectasia and Rad3-related protein (ATR). ATR is a key sensor for

DNA damage, activating the DNA damage checkpoint and leading to cell cycle

arrest. It is thought that inhibition of ATR can enhance the efficacy of

DNA-damaging agents, and could potentially also be efficacious as monotherapy

against tumors with high levels of replication stress induced by overexpression

of oncogenes. M6620 complements our strong DDR portfolio and is currently being

investigated in Phase I and II trials.

About M2698

A potential first-in-class, investigational small-molecule that is designed to

inhibit both p70S6K and Akt. Both targets are part of the phosphoinositide

3-kinase (PI3K) pathway, which is often dysregulated in solid tumors.

About tepotinib

Tepotinib is an investigational small-molecule inhibitor of the c-Met receptor

tyrosine kinase. 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 being investigated in two Phase II studies in

non-small cell lung cancer and hepatocellular carcinoma.

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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 2016, Merck generated sales of € 15.0 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 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.

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SOURCE: Merck KGaA