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

Thursday, May 18, 2017 Cancer News
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DARMSTADT, Germany, May 17, 2017 /PRNewswire/ --

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

ASCO

Abstract #

M7824 (anti-PD-L1/TGF- 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 approvals
  • Oral presentation on new immuno-oncology approach anti-PD-L1/TGF- 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 (cetuximab), and pipeline updates on the anti-PD-L1/TGF- 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 showcased.

In addition to avelumab data, Merck will also feature new research at ASCO on its investigational bifunctional immunotherapy anti-PD-L1/TGF- trap (M7824), which is thought to simultaneously block both PD-L1 and TGF-. 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 listed).


   
                                                   Presentation
                                                     Date / Time
    Title               Lead Author    Abstract #        (CDT)              Location

    M7824 (TGF-ss trap) JL Gulley      3006             June 5             Hall D1           
    Oral Presentation                                  13:15-16:27
    Solid Tumors
    Preliminary
    results from a
    phase 1 trial of
    M7824
    (MSB0011359C), a
    bifunctional
    fusion protein                           
    targeting PD-L1
    and TGF-beta, in
    advanced solid
    tumors               

   
                                                   Presentation
                                                      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
    Carcinoma
    (JAVELIN Renal
    100)
    First-line
    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
    Tumor)
    Exposure-response
    and PD-L1
    expression
    analysis of
    second-line
    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)
    First-line
    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)
    Exploratory
    biomarker analysis
    in patients with
    chemotherapy-refra                      
    ctory metastatic
    Merkel cell
    carcinoma treated
    with avelumab                                        June 4
    Urothelial              AB Apolo        4528       8:00-11:30        Hall A
    Carcinoma 
    Updated efficacy
    and safety of
    avelumab in
    metastatic
    urothelial
    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
    first-line
    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
    Tumor)
    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
   (JAVELIN DLBCL)
    Phase 1b/3 study
    of avelumab-based
    combination
    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
    Tumor)
    Avelumab in                             
    metastatic
    castration-resista
    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
    chemoradiotherapy
    (CRT) vs CRT for
    1st-line treatment
    of locally                                  
    advanced squamous
    cell carcinoma of
    the head and neck
    (LA SCCHN)        
   

    Publications
    Merkel Cell            M Bharmal      e21070              N/A           N/A
  Carcinoma (JAVELIN
    Merkel 200)
    Non-progression
    during avelumab
    treatment is
    associated with
    clinically
    relevant
    improvements in
    health-related
    quality of life in
    patients with
    Merkel cell
    carcinoma
    Merkel Cell            H Kaufman      e21065              N/A           N/A
   Carcinoma (JAVELIN
    Merkel 200)
    Patient
    experiences with
    avelumab vs
    chemotherapy for
    treating Merkel
    cell carcinoma:                 
    results from
    protocol-specified
    qualitative
    research          
   Non-Small Cell        Z Feng        e20581              N/A            N/A
 Lung Cancer
    (JAVELIN Solid
    Tumor)
    Comparative study
    of two PD-L1
    expression assays
    in patients with
    non-small cell
    lung cancer
    (NSCLC)

   
                                                    Presentation
                                                        Date / Time
    Title              Lead Author     Abstract #          (CDT)         Location
    Tepotinib                                             June 3
    Poster Sessions       S Qin             4087         8:00-11:30       Hall A
   Hepatocellular
    Carcinoma
    Phase Ib trial of 
    tepotinib in Asian
    patients with
    advanced
    hepatocellular
    carcinoma (HCC):
    Final data
    including
    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
    EGFR-mutant/c-Met-
    positive NSCLC:
    final data and
    long-term
    responders        

   
    Publications
    Hepatocellular       S Faivre          e15676           N/A            N/A
    Carcinoma
    Final phase Ib
    data for the oral
    c-Met inhibitor
    tepotinib in
    patients with
    previously treated
    advanced
    hepatocellular
    carcinoma         
    Advanced Lung         PK Paik           20541            N/A            N/A
    Adenocarcinoma
    Phase II trial of
    the c-Met
    inhibitor
    tepotinib in
    advanced lung
    adenocarcinoma
    with MET exon 14
    skipping mutations

   
                                                     Presentation
                                                         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 
    Publication
    Solid Tumors          B Van Triest      e14048            N/A           N/A
    A phase Ia/Ib
    trial of the
    DNA-dependent
    protein kinase
    inhibitor
    (DNA-PKi) M3814 in
    combination with
    radiotherapy in
    patients with
    advanced solid
    tumors            

               

                                                      Presentation
                                                           Date / Time
    Title                 Lead Author     Abstract #           (CDT)        Location
    M7583 (BTKi)        
     Publication
    B Cell                  S Rule           e14101            N/A            N/A
    Malignancies
    Phase I/II, first
    in human trial of
    the Bruton's
    tyrosine kinase
    inhibitor (BTKi)
    M7583 in patients
    with B cell
    malignancies      

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

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

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

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. 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 (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 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- 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 tumors.

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 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.

(Logo: http://photos.prnewswire.com/prnh/20151207/293543LOGO )



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