DARMSTADT, Germany /PRNewswire/ --
- NOT
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ASCO
Abstract # Avelumab*: 3023, 3044, 3055, TPS9086, TPS3101, 4042,
4047, 5509, 8034; evofosfamide: TPS9089, 8579; tepotinib: 2591;
tecemotide[†]: 3036.
New data on priority candidates from Merck's
oncology and immuno-oncology pipeline are being presented,
including avelumab, evofosfamide and tepotinib
Merck
will be presenting data at the 51st Annual Meeting of the American
Society of Clinical Oncology (ASCO), held in Chicago, Illinois, U.S., from May
29 to June 2, 2015. The data embody the company's focus on
cancers that are particularly difficult to treat and the ultimate
goal to provide treatments that help to prolong patients'
lives.
"We
are focused on shedding light on difficult-to-treat cancers, such
as soft tissue sarcomas and Merkel cell carcinoma, in order to make
a meaningful difference for patients," said Luciano Rossetti, Head of Global Research and
Development, Merck Serono, the biopharmaceutical business of Merck.
"Our data at ASCO 2015 demonstrate our commitment to deliver
innovation, through our internal expertise and capabilities, and
through strategic collaborations to advance differentiated new
therapies for these cancers."
Illumination and Innovation in Difficult-to-Treat
Cancers
Through a bold, science-focused and patient-driven approach, Merck
aims to discover and develop new therapies in cancers such as
ovarian cancer, metastatic Merkel cell carcinoma and advanced
hepatocellular carcinoma. Highlights from this year's ASCO include
data from the investigational fully human anti-PD-L1 monoclonal
antibody avelumab (also known as MSB0010718C), the investigational
c-Met inhibitor tepotinib (also known as MSC2156119J), and
evofosfamide (previously known as TH-302), an investigational
hypoxia-activated prodrug.
Abstracts are currently available on the ASCO website.
Collaborating to Tackle Cancer's Most Challenging
Issues
Merck
and Pfizer are collaborating on up to 20 high priority
immuno-oncology clinical development programs focused on the
therapeutic potential of avelumab which was initially discovered
and developed by Merck. This is the first time data will be
presented jointly on behalf of the alliance, including an oral
presentation on ovarian cancer and posters on gastric cancer,
non-small cell lung cancer and several other studies in a range of
patient populations.
In
addition, posters from two Phase II studies will be presented for
evofosfamide in multiple myeloma and melanoma. Evofosfamide is
being co-developed with Threshold Pharmaceuticals, Inc. and is
currently in Phase III studies for the treatment of soft tissue
sarcoma and for pancreatic cancer, as well as in a Phase II trial
for the treatment of non-squamous non-small cell lung cancer.
Precision Medicine to Improve Patient
Care
Merck
continues to place a strong emphasis on biomarker-driven research
with the goal of delivering personalized treatments and improving
patient outcomes. The company will be presenting data on tepotinib,
from a study evaluating the activity of tepotinib in patients with
solid tumors that overexpress c-Met. In addition, new analyses from
several independent studies will be presented that will offer
further insight into the value of Erbitux®(cetuximab) in
the treatment of 1st line RAS wild-type metastatic colorectal
cancer.
*Avelumab is the proposed International Nonproprietary Name (INN)
for the anti-PD-L1 monoclonal antibody (MSB0010718C).
[†] In September 2014, Merck discontinued all company-sponsored
clinical trials with tecemotide in non-small cell lung cancer
worldwide.
Notes to Editors
Accepted abstracts submitted by Merck related to our oncology and
immuno-oncology pipeline are listed below. In addition, a number of
investigator-sponsored studies have been accepted, including
several related to Erbitux and one to avelumab (not listed).
Avelumab
Title: Phase I, open-label,
multi-ascending dose trial of avelumab (MSB0010718C), an anti-PD-L1
monoclonal antibody, in Japanese patients with advanced solid
tumors
Lead Author: K Shitara
Abstract #: 3023
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Immunotherapy
Room/Details: S
Hall A (Poster Board: 349)
Title: Avelumab
(MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic
or locally advanced solid tumors: assessment of safety and
tolerability in a Phase I, open-label expansion study
Lead Author: K Kelly
Abstract #: 3044
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Immunotherapy
Room/Details: S
Hall A (Poster Board: 370)
Title: Pharmacokinetic
profile and receptor occupancy of avelumab (MSB0010718C), an
anti-PD-L1 monoclonal antibody, in a Phase I, open-label, dose
escalation trial in patients with advanced solid tumors
Lead Author: C Heery
Abstract #: 3055
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Immunotherapy
Room/Details: S
Hall A (Poster Board: 381)
Title: A Phase II,
open-label, multicenter trial to investigate the clinical activity
and safety of avelumab (MSB0010718C) in patients with metastatic
Merkel cell carcinoma
Lead Author: H Kaufman
Abstract #: TPS9086
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Melanoma/Skin Cancers
Room/Details: S
Hall A (Poster Board: 417a)
Title: Phase I expansion
cohort trial to investigate the safety and clinical activity of
avelumab (MSB0010718C) in patients with metastatic or locally
advanced solid tumors
Lead Author: C Heery
Abstract #: TPS3101
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Immunotherapy
Room/Details: S
Hall A (Poster Board: 420a)
Title: Prognostic
significance of tumor infiltrating immune cells and PD-L1
expression in gastric carcinoma in Chinese patients
Lead Author: R Geng
Abstract #: 4042
Presentation date/time
(CDT): June 1, 08:00-11:30
Session: Poster Session:
Gastrointestinal (Noncolorectal) Cancer
Room/Details: S
Hall A (Poster Board: 151)
Title: A Phase I dose
expansion trial of avelumab (MSB0010718C), an anti-PD-L1 antibody,
in Japanese patients with advanced gastric cancer
Lead Author: Y Yamada
Abstract #: 4047
Presentation date/time
(CDT): June 1, 08:00-11:30
Session: Poster Session:
Gastrointestinal (Noncolorectal) Cancer
Room/Details: S
Hall A (Poster Board: 156)
Title: Avelumab
(MSB0010718C), an anti-PD-L1 antibody, in patients with previously
treated, recurrent or refractory ovarian cancer: a Phase Ib,
open-label expansion trial
Lead Author: M Disis
Abstract #:5509
Presentation date/time
(CDT): June 1, 15:00-15:12
Session: Oral Presentation:
Clinical Science Symposium
Room/Details: E354b
Title: Avelumab
(MSB0010718C), an anti-PD-L1 antibody, in advanced NSCLC patients:
a Phase Ib, open-label expansion trial in patients progressing
after platinum-based chemotherapy
Lead Author: J Gulley
Abstract #: 8034
Presentation date/time
(CDT): June 1, 08:00-11:30
Session: Poster Session:
Lung Cancer- Non-Small Cell Metastatic
Room/Details: S
Hall A (Poster Board: 356)
Evofosfamide
Title: A Phase II
biomarker-enriched study of evofosfamide (EVO, TH-302) in patients
with advanced melanoma
Lead Author: E
McWhirter
Abstract #: TPS9089
Presentation date/time
(CDT): June 1, 13:15-16:45
Session: Poster Session:
Melanoma/Skin Cancers
Room/Details: S
Hall A (Poster Board: 327a)
Title: Preliminary safety
and efficacy of evofosfamide (TH-302), an investigational
hypoxia-activated prodrug combined with bortezomib and
dexamethasone in patients with relapsed/refractory multiple myeloma
(RRMM)
Lead Author: JP
Laubach
Abstract #: 8579
Presentation date/time
(CDT): May
31, 08:00-11:30
Session: Poster Session:
Lymphoma and Plasma Cell Disorders
Room/Details: S
Hall A (Poster Board: 397)
Tepotinib
Title: Efficacy, safety,
biomarkers and Phase II dose modeling in a Phase I trial of the
oral selective c-Met inhibitor tepotinib (MSC2156119J)
Lead Author: GS
Falchook
Abstract #: 2591
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Clinical Pharmacology and Experimental
Therapeutics
Room/Details: S
Hall A (Poster Board: 307)
Other Pipeline
Title: Phase I/II study of
tecemotide cancer immunotherapy for Japanese patients with
unresectable Stage III non-small cell lung cancer (NSCLC)
Lead Author: H
Nokihara
Abstract #: 3036
Presentation date/time
(CDT): May
30, 08:00-11:30
Session: Poster Session:
Developmental Therapeutics-Immunotherapy
Room/Details: S
Hall A (Poster Board: 362)
Avelumab, evofosfamide, tecemotide, tepotinib and all early-stage
products are currently under clinical investigation and have not
been approved for use in the U.S., E.U., Canada, or elsewhere. All investigational products have
not yet been proven to be either safe or effective and any claims
of safety and effectiveness can be made only after regulatory
review of the data and approval of the labeled claims.
The
full Erbitux patient information is available online
at http://www.ema.europa.eu/ema.
For
more information on Merck in oncology and immuno-oncology, please
visit:http://www.globalcancernews.com.
About Erbitux
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.
The
most commonly reported side effect with Erbitux is an acne-like
skin rash that seems to be correlated with a good response to
therapy. 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 colorectal cancer and for
the treatment of squamous cell carcinoma of the head and neck
(SCCHN).
Merck
licensed the right to market Erbitux outside the U.S.
and Canada from ImClone LLC, a wholly-owned subsidiary
of Eli Lilly and Company, in 1998. Merck has an ongoing commitment
to the advancement of oncology treatment and is currently
investigating novel therapies in highly targeted areas.
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational
hypoxia-activated prodrug that is thought to be activated under
severe tumor hypoxic conditions, a feature of many solid tumors.
Areas of low oxygen levels (hypoxia) in solid tumors are due to
insufficient blood vessel supply. Similarly, the bone marrow of
patients with hematological malignancies has also been shown, in
some cases, to be severely hypoxic.
Evofosfamide is currently under evaluation in two Phase III trials:
one in combination with doxorubicin versus doxorubicin alone in
patients with locally advanced unresectable or metastatic soft
tissue sarcoma (the TH-CR-406 trial), and the other in combination
with gemcitabine versus gemcitabine and placebo in patients with
locally advanced unresectable or metastatic pancreatic cancer (the
MAESTRO trial). Both Phase III trials are being conducted under
Special Protocol Assessment (SPA) agreements with the FDA. The FDA
and the European Commission have granted evofosfamide Orphan Drug
designation for the treatment of STS and pancreatic cancer.
Evofosfamide is also being investigated in a Phase II trial for the
treatment of non-squamous non-small cell lung cancer, and in
earlier-stage clinical trials of other solid tumors and
hematological malignancies.
Merck
signed a global license and co-development agreement for
evofosfamide with Threshold Pharmaceuticals, Inc.
in February 2012, with an option for Threshold to
co-commercialize in the U.S.
About Tepotinib
Tepotinib (also known as MSC2156119J) is an investigational
small-molecule inhibitor of the c-Met receptor tyrosine kinase that
has been shown to cause growth inhibition and regression of
hepatocyte growth factor-dependent and -independent tumors in
preclinical models. 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 currently under
evaluation in Phase I/II trials.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational fully
human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1
interactions, avelumab is thought to enable the activation of
T-cells and the adaptive immune system. By retaining a native
Fc-region, avelumab is thought to engage the innate immune system
and induce antibody-dependent cell-mediated cytotoxicity (ADCC).
In November 2014, Merck and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab.
About Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer. The global
strategic alliance between Merck and Pfizer enables the companies
to benefit from each other's strengths and capabilities and further
explore the therapeutic potential of avelumab, an investigational
anti-PD-L1 antibody initially discovered and developed by Merck.
The immuno-oncology alliance will jointly develop and commercialize
avelumab and advance Pfizer's PD-1 antibody. The alliance will
collaborate on up to 20 high priority immuno-oncology clinical
development programs, including combination trials, many of which
are expected to commence in 2015.
About Merck Serono
Merck
Serono is the biopharmaceutical business of Merck. With
headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150
countries to help patients with cancer, multiple sclerosis,
infertility, endocrine and metabolic disorders as well as
cardiovascular diseases. In the
United States and Canada, EMD Serono operates as a separately incorporated
subsidiary of Merck Serono.
Merck
Serono discovers, develops, manufactures and markets prescription
medicines of both chemical and biological origin in specialist
indications. We have an enduring commitment to deliver novel
therapies in our core focus areas of neurology, oncology,
immuno-oncology and immunology.
For
more information, please visit http://www.merckserono.com.
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Merck
is a leading company for innovative and top-quality high-tech
products in healthcare, life science and performance materials. The
company has six businesses - Merck Serono, Consumer Health,
Allergopharma, Biosimilars, Merck Millipore and Performance
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the quality of life for patients, to foster the success of
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oldest pharmaceutical and chemical company - since 1668, the
company has stood for innovation, business success and responsible
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Source: Merck Serono