Merck KGaA, Darmstadt, Germany to Present New Research Focused on Hard-to-Treat Cancers at ESMO 2016

Sep 28, 2016, 02:30 ET from Merck KGaA, Darmstadt, Germany

DARMSTADT, Germany, September 28, 2016 /PRNewswire/ --

Not intended for UK-based media

ESMO Abstract #
Avelumab: 777PD, 7775PD, 1154P, 842TiP, 844TiP; Erbitux: 527P, 491P, 967P, 994P; Tepotinib: 1257P, 1287TiP, 1292TiP

  • Merck KGaA, Darmstadt, Germany, to feature new research from marketed and pipeline compounds  
  • Preliminary results from combination study with avelumab in renal cell carcinoma, and updates on Phase II tepotinib program in
    non-small cell lung cancer, to be presented  
  • Merck KGaA, Darmstadt, Germany, to announce 2016 Grant for Oncology Innovation winners coinciding with ESMO 

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that new research from their marketed and pipeline compounds will be presented at this year's European Society for Medical Oncology (ESMO; October 7-11, 2016, Copenhagen, Denmark) annual meeting. Presentations will focus on hard-to-treat cancers, and include: study results for Erbitux® (cetuximab) in metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN); preliminary study results in bladder cancer and renal cell carcinoma (RCC) for avelumab, which is being developed in collaboration with Pfizer; and updates on the Phase II program for tepotinib* in non-small cell lung cancer (NSCLC).

"The data being presented at ESMO reflect our commitment to making a meaningful difference in patients' lives, in particular those who are affected by hard-to-treat cancers," said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. "We continue to focus on researching the full potential of Erbitux, as well as our ongoing pipeline development programs for avelumab and other early-stage oncology and immune-oncology compounds."

At ESMO, avelumab will be featured in four posters that add to the growing body of evidence of the potential of this investigational compound. These will include data updates in bladder cancer that confirm avelumab's potential in this hard-to-treat cancer; and preliminary results from a combination study with axitinib in RCC that support the rationale to evaluate the combination in a Phase III pivotal study. Tepotinib, a highly selective c-Met kinase inhibitor, will also be highlighted in three posters, with updates on the ongoing study program in c-Met-positive metastatic NSCLC.

Several studies, which will be presented at ESMO, once again reaffirm Erbitux as a standard-of-care therapy for mCRC patients with RAS wild-type tumors and patients with SCCHN.

Merck KGaA, Darmstadt, Germany, believes that to truly deliver the promise of innovation for patients, it is vital to support and encourage research from other endeavors. This is demonstrated through Merck KGaA, Darmstadt, Germany's Grant for Oncology Innovation (GOI) initiative, which awards researchers for their pioneering independent work in pushing the boundaries of creativity and science in order to deliver transformative innovation. The award ceremony will once again coincide with ESMO and takes place on Sunday, October 9, 2016.

*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 KGaA, Darmstadt, Germany-supported abstracts are listed below. In addition, a number of investigator-sponsored studies have been accepted, including several related to Erbitux (not listed).

    Title                    Lead       Abstract  Presentation   Session           Room/
                             Author     #         date/time                        Details  


    Impact of tumor           S Qin     527P      October 8      Poster Display    Hall E
    epidermal growth factor                       13:00-14:00    Session
    receptor (EGFR) status
    on the outcomes of
    first-line FOLFOX-4
    plus or minus cetuximab
    in patients (pts) with
    RAS-wild-type (wt)                        
    metastatic colorectal
    cancer (mCRC) in the                                       
    randomized phase 3                                         
    TAILOR trial                                      

    Impact of surgical       U Neumann  491P      October 8      Poster Display    Hall E
    resection of liver                            13:00-14:00    Session
    metastases on outcome
    of patients with
    metastatic colorectal
    carcinoma (mCRC)
    treated with a
    first-line therapy -
    Analysis of the
    KRAS-wildtype exon 2                      
    (KRAS-wt) subgroup of
    the German                                                 
    study ERBITAG                                 

    Observational study of   J Guigay   967P      October 9     Poster Display     Hall E
    the dose intensity                            13:00-14:00   Session
    relative to cetuximab
    in the first-line
    treatment of recurrent
    and/or metastatic
    squamous cell carcinoma                   
    of the head and neck:
    data on the maintenance                                    
    and bi-weekly use                                          
    (DIRECT study)                                 

    Cetuximab in             M Hecht    994P      October 9     Poster Display     Hall E
    combination with                              13:00-14:00   Session
    chemotherapy or
    radiotherapy in
    recurent and/or
    metastatic SCCHN in a                         
    non-selected patient
    cohort (interim                                            
    analysis of the phase                                      
    IV SOCCER trial)                            

    Title                    Lead       Abstract  Presentation   Session           Room/
                             Author     #         date/time                        Details


    Avelumab (MSB0010718C;   M Patel    777PD     October 9      Poster            Athens
    anti-PD-L1) in patients                       16:30-17:30    Discussion     
    with metastatic                                              Session
    urothelial carcinoma                                         Genitourinary
    progressed after                                             tumors, non-
    platinum-based therapy                                       prostate
    or platinum ineligible                

    Phase 1b dose-finding                                        Poster            Athens
    study of avelumab        J Larkin  775PD      October 9      Discussion
    (anti-PD-L1) + axitinib                       16:30-17:30    Session
    in treatment-naïve                                           Genitourinary
    patients with advanced                                       tumors, non-
    renal cell carcinoma                                         prostate 

    Evaluation of real       J Becker  1154P      October 9      Poster Display    Hall E
    world treatment                               13:00-14:00    Session
    outcomes in patients             
    with metastatic Merkel
    cell carcinoma (MCC)                                       
    following second line                                      

    A multicenter,           T Powles  842TiP     October 9      Poster Display    Hall E
    international,                                13:00-14:00    Session
    randomized, open-label
    phase 3 trial of
    avelumab + best
    supportive care (BSC)
    vs BSC alone as
    maintenance therapy
    after first-line
    chemotherapy in
    patients with advanced                                     
    urothelial cancer                                 
    (JAVELIN Bladder 100)                            

    Phase 3 study of         R Motzer  844TiP     October 9      Poster Display    Hall E
    avelumab in combination                       13:00-14:00    Session
    with axitinib versus       
    sunitinib as first-line
    treatment for patients                                     
    with advanced renal                               
    cell carcinoma (aRCC)                                  

    Title                    Lead      Abstract   Presentation   Session           Room/
                             Author    #          date/time                        Details

    Tepotinib plus           Y-L Wu    1257P      October 8      Poster Display    Hall E
    gefitinib in patients                         13:00-14:00    Session
    ant NSCLC: recommended
    phase II dose (RP2D),                                      
    tolerability, and                                          

    Design of a phase II     Y-L Wu    1287TiP    October 8      Poster Display    Hall E
    trial comparing                               13:00-14:00    Session
    tepotinib + gefitinib                         
    with cisplatin +
    pemetrexed in EGFR                                         
    c-Met+ NSCLC                              

    A phase II trial        P Paik     1292TiP    October 8      Poster Display    Hall E
    investigating the                             13:00-14:00    Session
    highly selective c-Met
    inhibitor tepotinib in
    stage IIIB/IV lung                     
    adenocarcinoma with MET
    exon 14 alterations                                        
    after failure of at                                        
    least one prior therapy                          

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About Avelumab  

Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. 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 is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

About Erbitux 

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.

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 colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany 

Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, generated sales of € 12.85 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, 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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Contact: Heike Schmiedt +49-6151-72-7498

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