- 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).
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)
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
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-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(R)) 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(R)) 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(R) (cetuximab)
Erbitux(R) 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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Source: Merck KGaA
