Merck Data at ESMO 2018 Congress Highlight Multiple Therapeutics with Potential to Transform Cancer Care

PR75627

DARMSTADT, Germany, Oct. 9, 2018 /PRNewswire=KYODO JBN/--

     

    Not intended for distribution in the USA, Canada or UK

    ESMO Abstract #

    Avelumab: LBA6_PR, 659P, 1290P, 1291P, 1282P, 877P; M7824 (TGF

beta-trap/anti-PD-L1) :1048O, 1463P, 1931P, 757P, 643P, 642P, 661P; tepotinib

(MET kinase inhibitor): 1377O, 621PD, 698P; M6620: 1437P; M3814: 1845P; M7583:

1014PD; abituzumab: 487P; Erbitux(R) (cetuximab): 124P, 484P, 509P, 493P, 521P,

510P, 481P, 486P, 1057P, 1108P, 1068P, 1064P, 1293P

    

    - First presentation of Phase III data for avelumab (plus axitinib) in

previously  untreated, advanced kidney cancer

    - New and updated data for bifunctional immunotherapy M7824

    - Results from Phase II trials for tepotinib, including in EGFR

TKI-resistant NSCLC

    - Additional pipeline data feature abstracts for a further four innovative

agents across

      multiple tumor types with a significant patient need

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

data from a variety of high-priority clinical development programs will be

presented at the ESMO 2018 Congress (European Society for Medical Oncology

Annual Meeting), October 19-23, 2018, Munich, Germany.

    In the year that Merck celebrates its 350-year anniversary, abstracts at

the congress represent a company record with eight therapeutic agents across 14

tumor types, reinforcing Merck's position at the forefront of clinical

development in oncology.

    "Our data at this year's European Society for Medical Oncology Congress

expand our understanding of avelumab in renal cell carcinoma and other tumors,

and demonstrate the headway we are making with our pipeline, including

bifunctional immunotherapy M7824 and tepotinib," said Luciano Rossetti, Global

Head of Research & Development for the Biopharma business of Merck. "We look

forward to many more years of real and significant progress towards our vision

of transforming the management and treatment of cancer."

    Data from the Phase III study JAVELIN Renal 101, evaluating avelumab* in

combination with axitinib, compared with sunitinib as initial therapy for

patients with advanced renal cell carcinoma (RCC), will be presented for the

first time during the Presidential Symposium at ESMO on Sunday, October 21,

2018 at 5:20 PM - 5:35 PM CEST. Avelumab is being jointly developed and

commercialized with Pfizer. The results represent the first positive Phase III

immunotherapy trial in combination with a tyrosine kinase inhibitor (TKI) in

any tumor type, supporting Merck's interest in the potential use of avelumab in

combination with currently approved therapies and novel agents. These results

will be submitted for publication in a peer-reviewed journal. Other updates

include new avelumab data in Merkel cell carcinoma (MCC) and advanced gastric

or gastroesophageal junction (GEJ) cancer.

    New data for M7824 will be presented from expansion cohorts of two ongoing

Phase I clinical trials, including the first tumor-specific data for squamous

cell carcinoma of the head and neck (SCCHN), biliary tract cancer, esophageal

squamous cell carcinoma and esophageal adenocarcinoma. In addition, updated

data for M7824 in patients with gastric cancer and non-small cell lung cancer

(NSCLC) will be shared. M7824, discovered in-house

at Merck, is an investigational bifunctional immunotherapy designed to combine

a transforming growth factor beta (TGF-beta) trap by 'fusing' it with the

anti-programmed death ligand-1 (PD-L1) mechanism. To date more than 650

patients with various types of solid tumors have been treated across the

program with M7824 and the safety profile is consistent with that observed with

other PD-1/PD-L1 inhibitors and previously described skin lesions

(keratoacanthomas, SCC, hyperkeratosis) associated with TGF-beta-inhibiting

therapies.

    Data for tepotinib** include results from three Phase II trials in

epidermal growth factor receptor (EGFR) TKI-resistant NSCLC and advanced

hepatocellular carcinoma, providing further evidence of this precision

medicine's potential clinical activity in a range of tumors. Tepotinib,

discovered in-house at Merck, is an investigational, oral MET inhibitor that is

designed to selectively inhibit the oncogenic MET receptor signalling caused by

MET (gene) alterations or MET protein overexpression.

    Additional pipeline abstracts feature updated data from Merck's

comprehensive DNA damage response (DDR) portfolio. These include results from a

Phase I trial investigating M6620 (formerly VX-970) in combination with

gemcitabine in patients with advanced NSCLC, and combined data from two Phase I

trials of DNA-dependent protein kinase inhibitor, M3814. Results will also be

shared from a Phase I/II trial of M7583, a Bruton's TKI, in patients with

B-cell malignancies, as well as a retrospective analysis of the Phase I/II

Poseidon study investigating abituzumab in patients with metastatic colorectal

cancer (mCRC).

    Data to be presented at the congress for Erbitux(R) will add to the growing

body of real-world evidence supporting the therapy's role as a standard of care

in RAS wild-type mCRC and first-line recurrent or metastatic SCCHN (R/M SCCHN),

and for patients with locally advanced SCCHN (LA SCCHN) who may not be able to

tolerate cisplatin-based regimens in full.

    *Avelumab is under clinical investigation for the treatment of RCC, MCC,

CRC, gastric and GEJ cancer, and has not been demonstrated to be safe and

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

approved for RCC, CRC, gastric or GEJ cancer by any health authority worldwide.

    **Tepotinib is the recommended International Nonproprietary Name (INN) for

the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical

investigation and not approved for any use anywhere in the world.

    Tepotinib, M7824, M3814, M7583, M6620 and abituzumab 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

    Key Merck-supported abstracts slated for presentation are listed below. In

addition, a number of investigator-sponsored studies have been accepted (not

listed).

   Title                   Lead Author   Abstract #   Presentation       

Location

                                                      Date / Time

                                                       (CEST)

    Avelumab

    Late-Breaking Abstracts

    JAVELIN Renal 101:      R Motzer      LBA6_PR     Sun, Oct 21,       Hall

A2 -

    a randomized,                                     4:30 - 6:10 PM     Room 18

    phase 3 study of                                  (5:20 - 5:35 PM

    avelumab +                                        lecture time)

    axitinib vs                                       

    sunitinib as

    first-line

    treatment of

    advanced renal

    cell carcinoma                         

    (aRCC)      

    Poster Sessions

    Avelumab                T Doi         659P        Sun, Oct 21        Hall

A3 -

    (anti-PD-L1) in                                   12:45 - 1:45 PM    Poster

Area

    Japanese patients                                                    

Networking Hub

    with advanced

    gastric or

    gastroesophageal

    junction cancer

    (GC/GEJC): updated

    results from the               

    phase 1b JAVELIN                                       

    Solid Tumor JPN                               

    trial                  

    Avelumab in             P Nathan      1290P       Sun, Oct 21,       Hall

A3 -

    European patients                                 12:45 - 1:45 PM    Poster

Area

    (pts) with                                                           

Networking Hub

    metastatic Merkel

    cell carcinoma

    (mMCC): experience                        

    from an ad hoc                                         

    expanded access                          

    program (EAP)

    Cost-effectiveness      M Bharmal     1291P       Sun, Oct 21,       Hall

A3 -

    (CE) of avelumab                                  12:45 - 1:45 PM    Poster

Area

    vs standard care                                                     

Networking Hub

    (SC) for the

    treatment of

    patients (pts)            

    with metastatic                                            

    Merkel cell                                 

    carcinoma (mMCC)   

    Responder analysis      SP D'Angelo   1282P       Sun, Oct 21,       Hall

A3 -

    based on                                          12:45 - 1:45 PM    Poster

Area

    patient-reported                                                     

Networking Hub

    outcomes (PROs)

    and clinical

    endpoints (CEPs)

    in patients (pts)

    with metastatic

    Merkel cell                                      

    carcinoma (mMCC)                                         

    treated with                                

    avelumab           

    First-line (1L) or      UN                        Mon, Oct 22,       Hall

A3 -

    second-line (2L)        Vaishampayan  877P        12:45 - 1:45 PM    Poster

Area

    avelumab                                                             

Networking Hub

    monotherapy in

    patients (pts)

    with advanced

    renal cell

    carcinoma (aRCC)

    enrolled in the  

    phase 1b JAVELIN  

    Solid Tumor trial  

    

    Title                         Lead Author   Abstract #  Presentation      

Location

                                                            Date / Time

                                                            (CEST

    M7824 (TGF β-trap/anti-PD-L1)

    Proffered Paper Session

    M7824                         BC Cho        1048O       Mon, Oct 22,      

ICM, Room

    (MSB0011359C), a                                        2:45 - 4:15 PM    

14B

    bifunctional                                            (3:00 PM

    fusion protein                                          lecture time)

    targeting PD-L1

    and TGF-β, in

    patients (pts)

    with advanced                             

    SCCHN: results                                   

    from a phase 1                                    

    cohort                         

    Poster Sessions

    Updated results of            L Paz-Ares    1463P       Sat, Oct 20,      

Hall A3 -

    M7824                                                   12:30 - 1:30 PM   

Poster Area

    (MSB0011359C), a                                                          

Networking Hub

    bifunctional

    fusion protein

    targeting TGF-β                                                

    and PD-L1, in                                                            

    second-line (2L)                                         

    NSCLC              

    Assessment of PD1/            T Mrowiec     1931P       Sun, Oct 21,      

Hall A3 -

    PD-L1                                                   12:45 - 1:45 PM   

Poster Area

    colocalization in                                                         

Networking Hub

    hepatocellular

    carcinoma (HCC)

    using brightfield

    double labeling                             

    and quantitative                                  

    digital image                       

    analysis          

    M7824                         C Yoo         757P        Sun, Oct 21,      

Hall A3 -

    (MSB0011359C), a                                        12:45 - 1:45 PM   

Poster Area

    bifunctional                                                              

Networking Hub

    fusion protein

    targeting PD-L1

    and TGF-β, in

    Asian patients

    with pretreated

    biliary tract

    cancer:   

    preliminary                                            

    results from a                          

    phase 1 trial      

    M7824                         B Tan          643P       Sun, Oct 21,      

Hall A3 -

    (MSB0011359C), a                                        12:45 - 1:45 PM   

Poster Area

    bifunctional                                                              

Networking Hub

    fusion protein

    targeting PD-L1

    and TGF-β, in

    patients with

    post-platinum

    esophageal

    adenocarcinoma                                  

    (EAC): preliminary                                       

    results from a                             

    phase 1 cohort      

    Phase 1 study                 CC Lin         642P       Sun, Oct 21,      

Hall A3 -

    results from an                                         12:45 - 1:45 PM   

Poster Area

    esophageal                                                                

Networking Hub

    squamous cell

    carcinoma (ESCC)

    cohort treated

    with M7824

    (MSB0011359C), a

    bifunctional

    fusion protein

    targeting

    transforming                                 

    growth factor β                                      

    (TGF-β) and                            

    PD-L1              

    Updated results               YJ Bang        661P       Sun, Oct 21,      

Hall A3 -

    from a phase 1                                          12:45 - 1:45 PM   

Poster Area

    trial of M7824                                                            

Networking Hub

    (MSB0011359C), a

    bifunctional

    fusion protein

    targeting PD-L1

    and TGF-β, in

    patients with                  

    pretreated                                             

    recurrent or                                            

    refractory gastric                                 

    cancer             

    

    Title                   Lead Author  Abstract #  Presentation      Location

                                                     Date / Time

                                                     (CEST)

    Tepotinib

    Proffered Paper Session

    Phase 2 study of        YL Wu        1377O       Fri, Oct 19,      Hall A2,

    tepotinib +                                      4:00 - 5:30 PM    Room 18

    gefitinib                                        (4:51 PM

    (TEP+GEF) in                                     lecture time)

    MET-positive

    (MET+)/epidermal

    growth factor

    receptor                            

    (EGFR)-mutant (MT)                    

    non-small lung                            

    cancer (NSCLC)    

    Poster Discussion

    Phase 2 trial of         BY Ryoo     621PD       Fri, Oct 19,      Hall B3,

    tepotinib vs                                     3:45 - 5:30 PM    Room 21

    sorafenib in Asian                               (4:25 PM

    patients (pts)                                   lecture time)

    with advanced                             

    hepatocellular                             

    carcinoma (HCC)   

    Poster Session

    Phase 2 efficacy         T Decaens   698P        Sun, Oct 21,      Hall A3 -

    and safety data                                  12:45 - 1:45 PM   Poster

Area

    for the MET                                                        

Networking Hub

    inhibitor

    tepotinib in

    patients (pts)

    with                                   

    sorafenib-treated                                   

    advanced                                                 

    hepatocellular                                           

    carcinoma (HCC)    

    

    Title              Lead Author  Abstract #  Presentation     Location

                                                Date / Time

                                                (CEST)          

    M6620

    Poster Session

    Phase I dose       R Plummer    1437P       Sat, Oct 20,     Hall A3 -

    expansion data for                          12:30 - 1:30 PM  Poster Area

    M6620 (formerly                                              Networking Hub

    VX-970), a

    first-in-class ATR

    inhibitor,

    combined with

    gemcitabine (Gem)

    in patients (pts)

    with advanced    

    non-small cell  

    lung cancer                            

    (NSCLC)      

    

    Title              Lead Author     Abstract #  Presentation     Location

                                                   Date / Time

                                                   (CEST)

    M3814

    Poster Session

    Safety, clinical   M Mau-Sørensen  1845P       Sat, Oct 20,     Hall A3 -

    activity and                                   12:30 - 1:30 PM  Poster Area

    pharmacological                                                 Networking

Hub

    biomarker

    evaluation of the

    DNA-dependent

    protein kinase

    (DNAPK) inhibitor                                        

    M3814: results                                            

    from two phase I   

    trials               

    

    Title              Lead Author   Abstract #  Presentation    Location

                                                 Date / Time

                                                 (CEST)

    M7583

    Poster Session

    Phase I/II, first  W Jurczak     1014PD      Sun, Oct 21,    Hall B3 -

    in human trial                               4:30 - 5:45 PM  Room 21

    with M7583, a

    Bruton's tyrosine

    kinase inhibitor

    (BTKi), in

    patients with B                           

    cell malignancies        

    

    Title              Lead Author   Abstract #  Presentation      Location

                                                 Date / Time

                                                 (CEST)

    Abituzumab

    Poster session

    Patient selection   R Laeufle    487P        Sun, Oct 21,      Hall A3 -

    for targeting                                12:45 - 1:45 PM   Poster Area

    integrin with                                                  Networking

Hub

    abituzumab in

    patients with

    metastatic

    colorectal cancer

    (mCRC). A

    retrospective

    analysis of the                                       

    randomized phase                                         

    I/II Poseidon                             

    study             

    

    Title              Lead Author        Abstract #  Presentation       

Location

                                                      Date / Time

                                                      (CEST)   

    Erbitux

    Poster Sessions

    Association of     L Miller-Phillips  124P        Sat, Oct 20,       Hall

A3 -

    microRNA-21                                       12:30 - 1:30 PM    Poster

Area

    (miR-21) with                                                        

Networking Hub

    efficacy of

    cetuximab (cet)

    and bevacizumab

    (bev) in patients

    with metastatic

    colorectal cancer                                     

    (mCRC) within the

    FIRE-3 study (AIO  

    KRK-0306)          

    Retrospective RAS   A Sobrero         484P        Sun, Oct 21,       Hall

A3 -

    analysis of the                                   12:45 - 1:45 PM    Poster

Area

    EPIC trial:                                                          

Networking Hub

    Cetuximab plus

    irinotecan versus

    irinotecan alone

    in patients with

    third- and                            

    further-line                                            

    metastatic                                 

    colorectal cancer

    Factors             DP Modest         509P        Sun, Oct 21,       Hall

A3 -

    influencing                                       12:45 - 1:45 PM    Poster

Area

    conversion to                                                        

Networking Hub

    resectability and

    survival after

    resection of

    metastases in RAS

    WT metastatic

    colorectal cancer                                       

    (mCRC): analysis                                            

    of FIRE-3-                                   

    AIOKRK0306         

    Initial report of   E Oki             493P        Sun, Oct 21,       Hall

A3 -

    a phase I/II study                                12:45 - 1:45 PM    Poster

Area

    of S-1 and                                                           

Networking Hub

    irinotecan (IRIS)

    in combination

    with cetuximab in

    patients with                                           

    wild-type (wt) RAS                                          

    metastatic                             

    colorectal cancer  

    miR-31 as a         Y Gaston-Mathé    521P        Sun, Oct 21,       Hall

A3 -

    prognostic and                                    12:45 - 1:45 PM    Poster

Area

    predictive marker                                                    

Networking Hub

    of disease-free

    survival (DFS) in

    resected stage III

    colon cancer: a                              

    retrospective                                            

    analysis of the   

    PETACC-8 trial     

    Targeted therapies  BC Xing           510P        Sun, Oct 21,       Hall

A3 -

    in conversion                                     12:45 - 1:45 PM    Poster

Area

    therapy in mCRC: A                                                   

Networking Hub

    systematic review  

    and meta-analysis  

    Phase II study of   H Osawa           481P        Sun, Oct 21,       Hall

A3 -

    cetuximab                                         12:45 - 1:45 PM    Poster

Area

    rechallenge in                                                       

Networking Hub

    patients with RAS

    wild-type

    metastatic           

    colorectal cancer:                                

    E-rechallenge            

    trial             

    Prospective         X García-Albéniz  486P        Sun, Oct 21,       Hall

A3 -

    biomarker study in                                12:45 - 1:45 PM    Poster

Area

    advanced RAS                                                         

Networking Hub

    wild-type                    

    colorectal cancer.

    POSIBA trial.      

    (GEMCAD 10-02)     

    Cetuximab +         C Le Tourneau     1057P       Sun, Oct 21,       Hall

A3 -

    platinum-based                                    12:45 - 1:45 PM    Poster

Area

    therapy (PBT) as a                                                   

Networking Hub

    first-line

    treatment for

    patients with

    recurrent/metastat

    ic squamous cell

    carcinoma of the

    head and neck (R/M                                             

    SCCHN): an                                                         

    observational                                       

    study (ENCORE)       

    Can concomitant     J Dunst           1108P        Sun, Oct 21,      Hall

A3 -     

    diseases predict                                   12:45 - 1:45 PM   Poster

Area

    the compliance                                                       

Networking Hub

    with cisplatin

    plus RT in

    patients with

    locally advanced

    squamous cell

    carcinoma of the

    head and neck (LA

    SCCHN)? An

    exploratory                                        

    endpoint analysis                                     

    of the COMPLY                                

    trial              

    Cetuximab in        JC Ham            1068P        Sun, Oct 21,      Hall

A3 -

    combination with                                   12:45 - 1:45 PM   Poster

Area

    methotrexate (MTX)                                                   

Networking Hub

    as first-line

    treatment in

    recurrent or

    metastatic (R/M)

    squamous cell

    carcinoma of the

    head and neck

    (SCCHN), a phase

    Ib - randomized                                     

    phase II study                                         

    versus single                                

    agent MTX          

    Cetuximab in        M Hecht           1064P         Sun, Oct 21,     Hall

A3 -   

    combination with                                    12:45 - 1:45 PM  Poster

Area

    platinum-based                                                       

Networking Hub

    chemotherapy or

    radiotherapy in

    patients with

    recurrent and/or

    metastatic SSCHN

    in clinical

    routine: Updated                                     

    interim results of                                         

    the prospective                              

    SOCCER study       

    Cetuximab in        F Peyrade         1293P          Sun, Oct 21,    Hall

A3 -

    patients with                                        12:45 - 1:45 PM Poster

Area

    unresectable                                                         

Networking Hu

    cutaneous squamous

    cell carcinoma is                                     

    safe and effective                                     

    - A real-life                                

    analysis   

    About Avelumab

    Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody.

Avelumab has been shown in preclinical models to engage both the adaptive and

innate immune functions. By blocking the interaction of PD-L1 with PD-1

receptors, avelumab has been shown to release the suppression of the T

cell-mediated antitumor immune response in preclinical models.[1] -[3] Avelumab

has also been shown to induce NK cell-mediated direct tumor cell lysis via

antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[3]-[5] In

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

and co-commercialize avelumab.

    Avelumab is currently being evaluated in the JAVELIN clinical development

program, which involves at least 30 clinical programs, including seven Phase

III trials, and more than 8,600 patients across more than 15 different tumor

types. For a comprehensive list of all avelumab trials, please visit

clinicaltrials.gov.

    Approved Indications in the US

    The US Food and Drug Administration (FDA) granted accelerated approval for

avelumab (BAVENCIO(R)) for the treatment of (i) adults and pediatric patients

12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii)

patients with locally advanced or metastatic urothelial carcinoma (mUC) who

have disease progression during or following platinum-containing chemotherapy,

or 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.

    Important Safety Information from the US FDA Approved Label

    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 BAVENCIO for mMCC and patients with locally advanced or mUC

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

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

infection and rash.

    About M7824

    M7824 is an investigational bifunctional immunotherapy that is designed to

bring together a TGF-beta trap and 'fuse' it with the anti-PD-L1 mechanism.

M7824 is designed to simultaneously block the two immunosuppressive pathways -

targeting both pathways aims to control tumor growth by potentially restoring

and enhancing anti-tumor responses. M7824 is currently in Phase I studies for

solid tumors.

    About Tepotinib

    Tepotinib (MSC2156119J) is an investigational, oral MET inhibitor that is

thought to inhibit oncogenic MET receptor signaling caused by MET (gene)

alterations, including both MET exon 14 skipping mutations and MET

amplifications, or MET protein overexpression. It is a precision medicine and

is designed to have a highly selective mechanism of action.

    About M6620

    M6620 (previously known as VX-970) is an investigational small-molecule

thought to inhibit ataxia telangiectasia and Rad3-related protein (ATR). ATR is

believed to be a key sensor for DNA damage, activating the DNA damage

checkpoint and leading to cell cycle arrest. Inhibition of ATR could

potentially enhance the efficacy of DNA-damaging agents, but is also being

investigated as a monotherapy against tumors with high levels of replication

stress induced by overexpression of oncogenes.

    About M3814

    M3814 is an investigational small-molecule which is thought to inhibit

DNA-dependent protein kinase (DNA-PK). DNA-PK is a key enzyme for

non-homologous end-joining (NHEJ), an important DNA double-strand break (DSB)

repair pathway. Clinical studies investigating combinations of M3814 with other

commonly used DNA-damaging agents such as radiotherapy and chemotherapy are

underway.

    About M7583

    M7583 is an investigational therapy that is thought to be a highly

selective covalent inhibitor of Bruton's tyrosine kinase (BTKi) designed to

minimize off-target effects.

    About Abituzumab

    Abituzumab is an investigational pan-alphanu integrin inhibiting monoclonal

antibody thought to show activity against alphavbeta1, 3, 5, 6 and 8 integrin

heterodimers. Merck entered into a development agreement with the SFJ

Pharmaceuticals Group for abituzumab in metastatic colorectal cancer (mCRC).

This collaboration will allow Merck and SFJ to develop the potential of

abituzumab in a targeted way, focusing on a patient population that may benefit

from the treatment the most.

    About Erbitux(R) (cetuximab)  

    Erbitux(R) is a 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. Based on in

vitro evidence, 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 100 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.

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    About Merck

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

science and performance materials. Almost 53,000 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 2017, Merck generated sales of EUR 15.3 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.

    References

    

    1) Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of

cancer immunotherapy. Cancer Control 2014;21:231-7.

    2) Dahan R et al. FcgammaRs modulate the anti-tumor activity of antibodies

targeting the PD-1/PD-L1 axis. Cancer Cell 2015;28:285-95.

    3) Boyerinas B et al. Antibody-dependent cellular cytotoxicity activity of

a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer

Immunol Res 2015;3:1148-57.

    4) Kohrt HE et al. Combination strategies to enhance antitumor ADCC.

Immunotherapy 2012;4:511-27.

    5) Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and

antibody-dependent cytotoxicity. Expert Opin Biol Ther 2017;17:515-23.

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SOURCE: Merck