Merck KGaA

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

Darmstadt, Germany (ots/PRNewswire) - Not intended for UK-based media

- Data to showcase  Merck KGaA, Darmstadt, Germany'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 data in mTNBC for  ATR inhibitor (M6620) from  Merck KGaA, 
  Darmstadt, Germany's  comprehensive portfolio in DNA damage 
  response    

Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany's rapidly evolving pipeline, including first data from potential first-in-class ataxia telangiectasia and Rad3-related protein (ATR) inhibitor M6620* (also known as VX-970).

"The Merck KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany. "The data reinforce Merck KGaA, Darmstadt, Germany's commitment to pursuing approaches that will bring important benefits to patients and transform the way cancer is treated."

Merck KGaA, Darmstadt, Germany'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 KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany-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).




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

September 9
JAVELIN Lung 100:      Reck M.            1377TiP      13:15 - 
14:15         Hall 8
updated design of
a phase 3 trial of
avelumab vs
platinum doublet
chemotherapy as
first-line (1L)
treatment for
metastatic or
recurrent PD-L1+
non-small-cell
lung cancer
(NSCLC)

September 10
JAVELIN MERKEL          D'Angelo S.P.       1227P         
13:15-14:15        Hall 8
200: Avelumab
treatment in
chemotherapy-naïve                          
patients with
metastatic Merkel
cell carcinoma
(mMCC).

September 10
Avelumab in             Le Tourneau C.       913P         
13:15-14:15        Hall 8
patients with
metastatic
adrenocortical                              
carcinoma (mACC):
results from the
JAVELIN Solid     
Tumor trial

September 10
Potential impact        Zheng J.             882P         
13:15-14:15        Hall 8
of
avelumab+axitinib
(A+Ax) on tumor
size (TS) compared
with historical
data of sunitinib                           
(S) as evaluated
by a modeling and
simulation (MS)
approach

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





Presentation

date/time
Title                     Lead author      Abstract #         
(CEST)          Location


September 1          Sevilla
M6620 (VX-970)            Telli M.L.           242PD    09:15 - 
10:45       auditorium
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   
triple-negative
breast cancer
(mTNBC)
(NCT02157792)                           

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

M2698
Poster session

September 9      Alicante
Phase I dose          Tsimberidou A.M.      370PD         
16:30-18:00    auditorium
escalation study
of M2698, a     
p70S6K/AKT
inhibitor, in
patients with
advanced cancer

September 11
Pharmacodynamic               Xiong W.       393P         
13:15-14:15        Hall 8
(PD) biomarkers
for the p70S6K/Akt
inhibitor, M2698:
translation from                           
animal to human
and its relevance
for dosing
rationale          





Presentation
Date /
Time
Title                     Lead Author     Abstract #             
(CEST)       Location
Erbitux(R):
Poster session

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

September 9
Quality of life                 Liu T.          593P       
13:15-14:15          Hall 8
(QoL) analyses in
patients with RAS
wild-type (wt)
metastatic
colorectal cancer
(mCRC) treated
with first-line                            
FOLFOX-4 plus or
minus cetuximab in
the phase 3 TAILOR
trial

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

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



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

Tepotinib
Poster session

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



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



Anti-PD-L1/TGF-? trap pathways
Poster session

September 11
Analysis of                   Zhang Y.        1645P         
13:15-14:15         Hall 8
programmed
death-ligand 1
(PD-L1)
expression,
transforming
growth factor
(TGF)-beta gene
expression
signatures (GES)        
and
tumor-infiltrating
immune cells (IC)
in hepatocellular
carcinoma (HCC):
rationale for
targeting PD-L1-
and TGF-beta                  

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 KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany 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 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 2016, Merck KGaA, Darmstadt, Germany, generated sales of EUR 15.0 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" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

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