Shaping Cancer Care Today and Tomorrow: Merck to Present New Data from Rapidly Evolving Pipeline at ASCO 2017


Shaping Cancer Care Today and Tomorrow: Merck to Present New Data from Rapidly Evolving Pipeline at ASCO 2017


DARMSTADT, Germany, May 18 /PRNewswire=KYODO JBN/ -

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

ASCO Abstract #

M7824 (anti-PD-L1/TGF-beta trap): 3006; Avelumab: 9086, 9530, 9557, 4528, 3059,

5037, e21070, e21065, e20581; Tepotinib: 4087, 8547, e15676, 20541; M3814

(DNA-PK): 2556, e14048; M7583 (BTKi): e14101

- ASCO data highlights Merck's strong and rapidly accelerating pipeline in

oncology, spanning immuno-oncology to DNA damage response  

- New avelumab data in metastatic Merkel cell carcinoma and previously treated

metastatic urothelial carcinoma, following recent U.S. FDA accelerated


- Oral presentation on new immuno-oncology approach anti-PD-L1/TGF-beta trap

(M7824); potential first-in-class bifunctional immunotherapy  

Merck, a leading science and technology company, today announced that new

research from its growing broad oncology portfolio, from immuno-oncology (IO)

to DNA damage response (DDR) approaches, will be presented across a broad range

of hard-to-treat cancers at this year's American Society of Clinical Oncology

annual meeting (ASCO; June 2-6, Chicago). Over 40 abstracts showcase the impact

of Merck's commitment to shaping cancer care today and tomorrow, including data

for avelumab*, which is being developed in collaboration with Pfizer,

Erbitux(R) (cetuximab), and pipeline updates on the anti-PD-L1/TGF-beta trap

M7824, the DNA-PK inhibitor M3814, the BTK inhibitor M7583, and the c-Met

inhibitor tepotinib**.

"We are focused on delivering innovation that matters to patients, as shown in

our ASCO data that spans across IO and DDR approaches to tackle some of the

hardest-to-treat cancers," said Luciano Rossetti, Executive Vice President,

Head of Global Research & Development at the biopharma business of Merck.

"Merck was among the first to leverage the potential of the PD1/PDL1 pathway

for patients, and we continue to build on that progress with our ASCO presence

and the two recent FDA accelerated approvals for avelumab."

Multiple avelumab presentations at ASCO include data in first-line metastatic

Merkel cell carcinoma (mMCC) and previously treated metastatic urothelial

carcinoma (UC), as well as results from the Phase Ib trial from the avelumab

combination trial with axitinib in renal cell carcinoma (RCC). Recently, the

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

avelumab for the treatment of mMCC and pretreated patients with locally

advanced or metastatic UC. Avelumab is currently being evaluated as both

monotherapy and combination therapy in an extensive clinical development

program. Beyond mMCC, locally advanced or metastatic UC and RCC, further

avelumab abstracts in non-small cell lung cancer and metastatic

castrate-resistant prostate cancer, locally advanced squamous cell carcinoma of

the head and neck, relapsed or refractory diffuse large B-cell lymphoma will be


In addition to avelumab data, Merck will also feature new research at ASCO on

its investigational bifunctional immunotherapy anti-PD-L1/TGF-beta trap (M7824),

which is thought to simultaneously block both PD-L1 and TGF-beta. An oral

presentation will showcase dose escalation Phase I clinical data exploring the

potential of M7824 in advanced solid tumors.

Pipeline updates at ASCO also include early clinical results for both

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

tyrosine kinase, M7583, an oral, highly selective, covalent inhibitor of

Bruton's tyrosine kinase (BTK), and the first clinical data for M3814, an

investigational DNA-dependent protein kinase (DNA-PK) inhibitor. Merck is

investing significant resources in the promising area of DDR to be a leader in

this field. Merck has recently in-licensed two promising clinical-stage

programs from Vertex.

This highly focused approach to research and development channels Merck's

scientific expertise in areas of high unmet need, a legacy started with

Erbitux. Multiple presentations at ASCO reinforce Erbitux as a standard-of-care

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

metastatic colorectal cancer (mCRC), providing valuable information about

biomarkers, disease response, and the importance of tumor location in mCRC, to

best target treatment to the right patients.

*Avelumab is under clinical investigation for treatment of NSCLC, RCC, DLBCL,

SSCHN and mCRPC and has not been demonstrated to be safe and effective for

these indications. There is no guarantee that avelumab will be approved for

NSCLC, RCC, DLBCL, SSCHN and mCRPC by any health authority worldwide.

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

(also known as MSC2156119J).

Tepotinib, M7824 and M3814 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 key abstracts slated for presentation are listed

below. In addition, a number of investigator-sponsored studies have been

accepted, including multiple abstracts related to Erbitux and avelumab (not




                                              Date / Time

Title               Lead Author    Abstract #        (CDT)              



M7824 (TGF-ss trap) JL Gulley      3006        June 5  Hall D1            

    Oral Presentation                          13:15-16:27

    Solid Tumors


    results from a

    phase 1 trial of


    (MSB0011359C), a


    fusion protein                            

    targeting PD-L1

    and TGF-beta, in

    advanced solid




                                             Date / Time

Title             Lead Author   Abstract #    (CDT)           Location

    Avelumab                                   June 5

Oral Presentation  TK Choueiri     4504      8:00-11:00     Arie Crown Theater

     Renal Cell


    (JAVELIN Renal



    avelumab +

    axitinib therapy

    in patients with                             

    advanced renal

    cell carcinoma:

    results from a                                               

    phase 1b trial     


    Poster Sessions                                     June 3

    Non-Small Cell          JL Gulley       9086      8:00-11:30         Hall A

    Lung Cancer

    (JAVELIN Solid



    and PD-L1


    analysis of


    avelumab in

    patients with                           

    advanced NSCLC:

    Data from the

    JAVELIN Solid

    Tumor trial        

    Merkel Cell                                        June 3

    Carcinoma (JAVELIN     S D'Angelo       9530      13:15-16:45        Hall A

    Merkel 200)


    avelumab treatment

    in patients with

    metastatic Merkel                        

    cell carcinoma:

    preliminary data

    from an ongoing

    study                                               June 3

    Merkel Cell            I Shapiro        9557      13:15-16:45        Hall A

    Carcinoma (JAVELIN

    Merkel 200)


    biomarker analysis

    in patients with


    ctory metastatic

    Merkel cell

    carcinoma treated

    with avelumab                                        June 4

    Urothelial              AB Apolo        4528       8:00-11:30        Hall A


    Updated efficacy

    and safety of

    avelumab in



    carcinoma: pooled                        

    analysis from 2

    cohorts of the

    phase 1b JAVELIN

    Solid Tumor study                                    June 4

    Renal Cell           TK Choueiri     TPS4594       8:00-11:30        Hall A

    Carcinoma (JAVELIN

    Renal 101)

    Avelumab plus

    axitinib vs

    sunitinib as


    treatment of

    advanced renal                               

    cell carcinoma:

    phase 3 study

    (JAVELIN Renal

    101)                                                June 5

    Pan-Tumor              K Kelly          3059       8:00-11:30        Hall A

    (JAVELIN Solid


    Safety profile of

    avelumab in

    patients with                            

    advanced solid

    tumors: a JAVELIN

    pooled analysis of

    phase 1 and 2 data                                    June 5

    Lymphoma (TiP)         R Chen         TPS7575        8:00-11:30      Hall A


    Phase 1b/3 study

    of avelumab-based


    regimens in

    patients (pts)

    with relapsed or                             

    refractory diffuse

    large B-cell

    lymphoma (R/R

    DLBCL)                                                June 5

    Prostate Cancer    F. Fakhrejahani      5037        13:15-16:45      Hall A

    (JAVELIN Solid


    Avelumab in                              



    nt prostate cancer

    (mCRPC)                                               June 5

    Head and Neck          NY Lee        TPS6093        13:15-16:45      Hall A

    Cancer (TiP)

    (JAVELIN Head and

    Neck 100)

    JAVELIN Head and

    Neck 100: a phase

    3 trial of

    avelumab in

    combination with


    (CRT) vs CRT for

    1st-line treatment

    of locally                                   

    advanced squamous

    cell carcinoma of

    the head and neck

    (LA SCCHN)         



    Merkel Cell           M Bharmal      e21070              N/A           N/A

    Carcinoma (JAVELIN

    Merkel 200)


    during avelumab

    treatment is

    associated with



    improvements in


    quality of life in

    patients with

    Merkel cell


    Merkel Cell           H Kaufman      e21065              N/A           N/A

    Carcinoma (JAVELIN

    Merkel 200)


    experiences with

    avelumab vs

    chemotherapy for

    treating Merkel

    cell carcinoma:                  

    results from




    Non-Small Cell        Z Feng        e20581              N/A            N/A

    Lung Cancer

    (JAVELIN Solid


    Comparative study

    of two PD-L1

    expression assays

    in patients with

    non-small cell

    lung cancer




                                                        Date / Time

Title              Lead Author     Abstract #          (CDT)         Location

    Tepotinib                                             June 3

    Poster Sessions     S Qin             4087         8:00-11:30       Hall A



    Phase Ib trial of  

    tepotinib in Asian

    patients with



    carcinoma (HCC):

    Final data


    long-term outcomes                                    June 3

    Non-Small Cell      Y-L Wu             8547        8:00-11:30       Hall A

    Lung Cancer

    Phase Ib study of

    tepotinib in


    positive NSCLC:

    final data and






    Hepatocellular       S Faivre          e15676           N/A            N/A


    Final phase Ib

    data for the oral

    c-Met inhibitor

    tepotinib in

    patients with

    previously treated




    Advanced Lung        PK Paik           20541            N/A            N/A


    Phase II trial of

    the c-Met


    tepotinib in

    advanced lung


    with MET exon 14

    skipping mutations



                                                         Date / Time

    Title              Lead Author      Abstract #       (CDT)         Location

    M3814 (DNA-PK)

    Poster Session                                          June 5

    Solid Tumors       M van Bussel       2556         8:00-11:30       Hall A

    A multicenter

    phase I trial of

    the DNA-dependent                      

    protein kinase

    (DNA-PK) inhibitor

    M3814 in patients

    with solid tumors  


    Solid Tumors       B Van Triest      e14048            N/A           N/A

    A phase Ia/Ib

    trial of the


    protein kinase


    (DNA-PKi) M3814 in

    combination with

    radiotherapy in

    patients with

    advanced solid




                                                           Date / Time

    Title            Lead Author     Abstract #           (CDT)        Location

    M7583 (BTKi)         


    B Cell              S Rule           e14101            N/A            N/A


    Phase I/II, first

    in human trial of

    the Bruton's

    tyrosine kinase

    inhibitor (BTKi)

    M7583 in patients

    with B cell


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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.


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

avelumab (BAVENCIO(R)) 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. 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 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 include fatigue, musculoskeletal pain, diarrhea, nausea,

infusion-related reaction, peripheral edema, decreased appetite/hypophagia,

urinary tract infection and rash.

About Erbitux(R) (cetuximab)  

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. 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 M3814

M3814 is an investigational small-molecule inhibitor of DNA-dependent protein

kinase (DNA-PK). DNA-PK is a key enzyme for non-homologous end-joining (NEHJ),

the most important DNA double strand break repair pathway (DSB), and could

potentially enhance the efficacy of many commonly used DNA-damaging agents such

as radiotherapy and chemotherapy. M3814 complements Merck's extensive DNA

damage response (DDR) portfolio and is currently in Phase I studies.

About M7824

M7824, anti-PD-L1/TGF-beta trap, is an investigational potentially first-in-class

bi-functional immunotherapy designed to simultaneously block two

immuno-inhibitory pathways (PD-L1 and transforming growth factor beta) that are

commonly used by cancer cells to evade the immune system. The aim of this

investigational drug is to control tumor growth by restoring and enhancing

anti-tumor immune responses. M7824 is currently in Phase I studies for solid


About Tepotinib

Tepotinib (also known as MSC2156119J) 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 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 2016, Merck generated sales of EUR 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 KGaA, Darmstadt, Germany holds the global rights to the

"Merck" name and brand except in the United States and Canada, where the

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

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