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31.08.2017 – 00:11

Merck KGaA

Merck: Driving Innovation in Cancer Care at ESMO 2017 With New Data in Hard-to-Treat Cancers

Darmstadt, GermanyDarmstadt, Germany (ots/PRNewswire)

Not intended for U.K. or U.S. based media

ESMO 2017 abstract #

Erbitux®: 576P, 593P, 1068P, 1579P; avelumab: 1227P, 913P, 1377TiP, 882P, 856P; M6620 (ATR inhibitor): 242PD; M2698 (dual p70S6K/Akt inhibitor): 370PD, 393P; tepotinib (c-Met kinase inhibitor): 701P

- Data to showcase Merck's strong and diverse pipeline ranging from 
  immuno-oncology to DNA damage response 
- Avelumab data validate potential in hard-to-treat cancers and 
  highlight progress of the JAVELIN clinical development program 
- First  stand-alone  data  in  mTNBC  for  ATR inhibitor  (M6620)  
  from  Merck's  comprehensive portfolio in DNA damage response    

Merck, a leading science and technology company, today announced it will present data for a number of tumor types across its rapidly evolving pipeline. A total of 23 abstracts, representing five therapeutic agents, will highlight the company's expanding scientific expertise at this year's European Society for Medical Oncology congress (ESMO 2017; September 8-12, Madrid, Spain).

Data to be presented include continued reinforcement of the role of established brand Erbitux® (cetuximab) as a standard of care therapy, with quality of life (QoL) data in colorectal cancer (CRC) and real-world data in both CRC and squamous cell carcinoma of the head and neck (SCCHN); updated efficacy and safety data for avelumab in metastatic Merkel cell carcinoma (mMCC) and urothelial carcinoma (UC) among other cancers; and new data and updates from Merck's rapidly evolving pipeline, including first stand-alone data in metastatic triple negative breast cancer (mTNBC) from potential first-in-class ataxia telangiectasia and Rad3-related protein (ATR) inhibitor M6620* (also known as VX-970).

"The Merck Oncology Franchise has had a momentous year, particularly with the positive regulatory milestones achieved for avelumab. The story continues to evolve at ESMO 2017 from our legacy with Erbitux to our diverse and robust pipeline which has potential novel molecules that could become new standards of care," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. "The data reinforce Merck's commitment to pursuing approaches that will bring important benefits to patients and transform the way cancer is treated."

Merck's innovative approach and strategic collaborations in oncology are exemplified through the ongoing partnership with Pfizer, and the significant progress of avelumab. Granted two accelerated approvals** by the U.S. Food and Drug Administration (FDA) this year, more recently the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of avelumab as monotherapy for the treatment of adult patients with mMCC. ESMO 2017 includes new data for avelumab in the treatment of mMCC, a rare and aggressive skin cancer, and 12-month follow-up data in pre-treated patients with locally advanced or metastatic UC. The progress of the broader JAVELIN clinical development program will also be highlighted, with updated data in hard-to-treat tumors such as metastatic adrenocortical carcinoma (mACC).

The addition of the recently acquired Vertex DNA damage response (DDR) portfolio to its own in-house DDR platform has positioned Merck as one of the key players in the DDR field. The company's broad DDR portfolio includes inhibitors for enzymes of major DDR pathways, such as ATR, DNA-PK and ATM. At ESMO 2017, first data will be presented for ATR inhibitor M6620 in metastatic triple-negative breast cancer (mTNBC). M6620 is currently being investigated in several ongoing Phase I trials across a variety of tumor types.

Other pipeline updates will include data on the potential first-in-class dual p70S6K/Atk inhibitor M2698*; and tepotinib***, a highly selective c-Met kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC).

Product related information contained herein is subject to local product approval and can therefore vary from country to country. For information relevant to your country, please check in with local regulatory authorities.

*M6620, M2698 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.

***Tepotinib is the proposed International Non-proprietary Name (INN) for the c-Met kinase inhibitor (also known as MSC2156119J).

Notes to editors

Accepted Merck-supported key abstracts at ESMO 2017 are listed below. In addition, a number of abstracts with data from investigator-sponsored studies have been accepted, including abstracts related to Erbitux (not listed).

Date / Time
Title              Lead Author   Abstract #  (CEST)          
Poster sessions

JAVELIN Lung 100:
updated design of
a phase 3 trial of
avelumab vs
platinum doublet
chemotherapy as
first-line (1L)
treatment for
metastatic or
recurrent PD-L1+
lung cancer                                  September 9
(NSCLC)            Reck M.       1377TiP     13:15 - 14:15   Hall

200: Avelumab
treatment in
patients with
metastatic Merkel
cell carcinoma                               September 10
(mMCC).            D'Angelo S.P. 1227P       13:15-14:15     Hall

Avelumab in
patients with
carcinoma (mACC):
results from the
JAVELIN Solid      Le Tourneau               September 10
Tumor trial        C.            913P        13:15-14:15     Hall

Potential impact
(A+Ax) on tumor
size (TS) compared
with historical
data of sunitinib                           
(S) as evaluated
by a modeling and
simulation (MS)                              September 10
approach           Zheng J.      882P        13:15-14:15     Hall

Avelumab treatment
of metastatic
carcinoma (mUC) in
the phase 1b
Tumor study:
updated analysis
with greater than
or equal to6
months of
follow-up in all                              September 10
patients            Apolo A.B.    856P        13:15-14:15     
Hall 8

Title              Lead author   Abstract #  (CEST)          
M6620 (VX-970)
Poster session

Initial results of
a phase 1 dose
expansion cohort
of M6620 (VX-970),
a first-in-class
ATR inhibitor, in
combination with
cisplatin (Cis) in
patients (pts)                                              
with metastatic
breast cancer
(mTNBC)                                       September 10   
(NCT02157792)      Telli M.L.     242PD       09:15 - 10:45  

Title              Lead author   Abstract #  (CEST)          
Poster session

Phase I dose
escalation study
of M2698, a
inhibitor, in
patients with      Tsimberidou               September 9     
advanced cancer    A.M.          370PD       16:30-18:00     

(PD) biomarkers
for the p70S6K/Akt
inhibitor, M2698:
translation from
animal to human
and its relevance
for dosing                                   September 11
rationale          Xiong W.      393P        13:15-14:15     Hall

Title              Lead author   Abstract #  (CEST)          
Poster session

Biomarker testing
practices in the
clinical practiCe
stUdy in the
management of
colorectal cancer                          
[mCRC] with
eRbitux in
combination with
chemothErapy)      Aravantinos             September 9
study              G.            576P      13:15-14:15     Hall 8

Quality of life
(QoL) analyses in
patients with RAS
wild-type (wt)
colorectal cancer
(mCRC) treated
with first-line                            

FOLFOX-4 plus or
minus cetuximab in
the phase 3 TAILOR                          September 9
trial              Liu T.        593P       13:15-14:15    Hall 8

ENCORE: a phase 4
study of cetuximab
and platinum-based
therapy (PBT) for
the first-line
treatment of
patients with
ic squamous cell
carcinoma of the
head and neck (R/M Le Tourneau              September 10
SCCHN)             C.            1068P      13:15-14:15    Hall 8

A survey of
patient acceptance                         
of skin toxicities
cetuximab-based                             September 10
therapy            Tischer B.    1579P      13:15-14:15    Hall 8 

Title             Lead author  Abstract #  (CEST)          
Poster session

Final data from a
phase Ib trial of                         
tepotinib in Asian
patients with
hepatocellular                             September 9
carcinoma (HCC)   Qin S.       701P        13:15-14:15     Hall 8 

Title              Lead author  Abstract #  (CEST)         
trap pathways
Poster session
Analysis of
death-ligand 1
growth factor
(TGF)-beta gene
signatures (GES)                         
immune cells (IC)
in hepatocellular
carcinoma (HCC):
rationale for
targeting PD-L1-                          September 11
and TGF-beta        Zhang Y.    1645P     13:15-14:15       Hall 

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 in the US

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. 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. Avelumab is not approved for any indication in any market outside the U.S.

Important Safety Information

The warnings and precautions for avelumab (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 for mMCC and patients with locally advanced or metastatic UC 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 M6620

Also known as VX-970, M6620 is an investigational small-molecule inhibitor of ataxia telangiectasia and Rad3-related protein (ATR). ATR is a key sensor for DNA damage, activating the DNA damage checkpoint and leading to cell cycle arrest. It is thought that inhibition of ATR can enhance the efficacy of DNA-damaging agents, and could potentially also be efficacious as monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes. M6620 complements our strong DDR portfolio and is currently being investigated in Phase I and II trials.

About M2698

A potential first-in-class, investigational small-molecule that is designed to inhibit both p70S6K and Akt. Both targets are part of the phosphoinositide 3-kinase (PI3K) pathway, which is often dysregulated in solid tumors.

About tepotinib

Tepotinib 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 being investigated in two Phase II studies in non-small cell lung cancer and hepatocellular carcinoma.

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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 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.

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