Merck KGaA, Darmstadt, Germany: Driving Innovation in Cancer Care at ESMO 2017 With New Data in Hard-to-Treat Cancers
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
the same time they become available on the EMD Group Website. In case you are a
resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to
register again for your online subscription of this service as our newly
introduced geo-targeting requires new links in the email. You may later change
your selection or discontinue this service
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
(Logo: http://photos.prnewswire.com/prnh/20160629/384917LOGO )
SOURCE: Merck KGaA
本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。
このプレスリリースには、報道機関向けの情報があります。
プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。
