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

Merck KGaA

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

PR69846

DARMSTADT, Germany, August 31, 2017 /PRNewswire=KYODO JBN/ --

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

    

                                                         Presentation

                                                           Date / Time

Title                     Lead Author     Abstract #             (CEST)       

Location

Anti-PD-L1/TGF-β 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.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at

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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 € 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.

Your Contact: Martina Brunner, +49-6151-724-3959

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SOURCE: Merck KGaA

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