Tuesday, October 4, 2016

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



          - 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(R) (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  
                                                                        (CDT)              

    Erbitux

    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
    cetuximab-based
    first-line therapy -
    Analysis of the
    KRAS-wildtype exon 2                      
    (KRAS-wt) subgroup of
    the German                                                 
    non-interventional                                         
    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
    platinum-based
    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
                                                     (CDT)

    Avelumab

    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-na?ve                                                                    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                                      
    chemotherapy                                           
   
    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
    platinum-based         
    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
                                                                          (CDT)    
    Tepotinib

    Tepotinib plus             Y-L Wu    1257P      October 8      Poster Display    Hall E
    gefitinib in patients                                     13:00-14:00   Session
    with
    c-Met-positive/EGFR-mut                       
    ant NSCLC: recommended
    phase II dose (RP2D),                                      
    tolerability, and                                          
    efficacy                                    
   
    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                                         
    inhibitor-resistant,                                       
    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                          

 
          For further information and press materials please visit:http://www.emdgroup.com/emd/media/media_center_oncology.html

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