THOUSAND OAKS, Calif.,
May 15, 2019 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced that data from its oncology pipeline
will be presented at the 55th Annual Meeting of the
American Society of Clinical Oncology (ASCO) in Chicago, May 31-June 4,
2019. Seven investigational assets will be featured across a
range of hematologic malignancies and solid tumors.
"Biology and human genetics have been the foundation of Amgen's
innovation for the last four decades," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "Based on the fundamentals of
our science and the speed at which we are moving, I believe Amgen
will have a profound effect on how certain cancers are treated in
the future. We are committed to bringing novel cancer therapies
more quickly than ever before to the patients who need them."
Notable data from the Company's oncology pipeline include
first-in-human data for investigational AMG 510, the first
KRASG12C inhibitor to reach the clinical stage in
patients with locally-advanced or metastatic KRASG12C
mutant solid tumors. Additional early-stage pipeline data will
showcase Amgen's bispecific T cell engager (BiTE®)
platform across hematologic malignancies and solid tumors,
including for the first time, in prostate cancer. BiTE molecules
are designed to engage patients' T cells to tumor-specific
antigens, activating the cytotoxic potential of T cells with the
goal of eliminating detectable cancer. Updated results will also be
presented from a Phase 1 dose escalation study evaluating
investigational AMG 420, a B-cell maturation antigen (BCMA)
targeting BiTE molecule, in patients with relapsed or refractory
multiple myeloma.
A complete listing of Amgen's abstracts is available on the ASCO
website. Notable abstracts include:
Clinical Data Abstracts
- Phase 1 Study of Pasotuxizumab (BAY 2010112), a
PSMA-Targeting Bispecific T cell Engager (BiTE) Immunotherapy for
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Abstract #5034, Poster Presentation, Saturday, June 1 from 1:15-4:15 p.m. CT in McCormick Place, Hall
A
- Evaluation of AMG 420, an anti-BCMA Bispecific T-cell
Engager (BiTE) Immunotherapy, in R/R Multiple Myeloma (MM)
Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose
Escalation Study
Abstract #8007, Oral Presentation,
Sunday, June 2 from 11:57
a.m.–12:09 p.m. CT in McCormick
Place, Room E451
- Phase 1 Study Evaluating the Safety, Tolerability,
Pharmacokinetics (PK), and Efficacy of AMG 510, a Novel Small
Molecule KRASG12C Inhibitor, in Advanced Solid
Tumors
Abstract #3003, Oral Presentation, Monday, June 3 from 9–9:12
a.m. CT in McCormick Place, Room S406
Trials-in-Progress Abstracts
- Phase 1 Study of AMG 757, a Half-Life Extended Bi-Specific T
Cell Engager (BiTE) Antibody Construct Targeting DLL3, in Patients
with Small Cell Lung Cancer (SCLC)
Abstract #TPS8577, Poster
Presentation, Sunday, June 2 from
8–11 a.m. CT in McCormick Place, Hall A
- Phase 1 Study of AMG 119, a Chimeric Antigen Receptor (CAR)
T Cell Therapy Targeting DLL3, in Patients with Relapsed/Refractory
Small Cell Lung Cancer (SCLC)
Abstract #TPS8576, Poster
Presentation, Sunday, June 2 from
8–11 a.m. CT in McCormick Place, Hall A
- Novel anti-EGFRvIII Bispecific T Cell Engager (BiTE)
Antibody Construct in Glioblastoma (GBM): Trial in Progress of AMG
596 in Patients with Recurrent or Newly Diagnosed
Disease
Abstract #TPS2071, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick
Place, Hall A
Amgen Webcast Investor Meeting
Amgen will host a
webcast investor meeting at ASCO 2019 on Monday, June 3 at 6:30
p.m. CT. David M. Reese,
M.D., executive vice president of Research and Development at
Amgen, along with members of Amgen's clinical development team and
clinical investigators, will participate at the investor meeting to
discuss Amgen's oncology program and data presented at ASCO
2019.
Live audio of the conference call will be broadcast over the
internet simultaneously and will be available to members of the
news media, investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given at certain investor and
medical conferences, can be accessed on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the
event.
About KRAS
The subject of more than three decades of
research, RAS proteins make up the most frequently mutated
gene family in human cancers.1,2 Within this family,
KRAS is the most prevalent variant and is particularly common
in solid tumors.2 A specific mutation known as
KRASG12C accounts for approximately 12 percent of all
KRAS mutations across tumor types.3 Amgen is
exploring the potential of KRASG12C inhibition across a
broad variety of tumor types.
About
BiTE® Technology
Bispecific T cell
engager (BiTE®) technology is a targeted immuno-oncology
platform that is designed to engage patients' own T cells to any
tumor-specific antigen, activating the cytotoxic potential of T
cells to eliminate detectable cancer. The BiTE immuno-oncology
platform has the potential to treat different tumor types through
tumor-specific antigens. The BiTE platform leads to off-the-shelf
solutions, which have the potential to make innovative T cell
treatment available to all providers when their patients need it.
Amgen is advancing more than a dozen BiTE molecules across a broad
range of hematologic malignancies and solid tumors, further
investigating BiTE technology with the goal of enhancing patient
experience and therapeutic potential.
About Amgen Oncology
Amgen Oncology is searching for
and finding answers to incredibly complex questions that will
advance care and improve lives for cancer patients and their
families. Our research drives us to understand the disease in the
context of the patients' life – not just their cancer journey – so
they can take control of their lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
For more information, follow us on
www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted,
Amgen is providing this information as of the date of this news
release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products, including our
devices, after they are on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
subject to significant sanctions. While we routinely obtain patents
for our products and technology, the protection offered by our
patents and patent applications may be challenged, invalidated or
circumvented by our competitors, or we may fail to prevail in
present and future intellectual property litigation. We perform a
substantial amount of our commercial manufacturing activities at a
few key facilities, including in Puerto
Rico, and also depend on third parties for a portion of our
manufacturing activities, and limits on supply may constrain sales
of certain of our current products and product candidate
development. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. The
discovery of significant problems with a product similar to one of
our products that implicate an entire class of products could have
a material adverse effect on sales of the affected products and on
our business and results of operations. Our efforts to acquire
other companies or products and to integrate the operations of
companies we have acquired may not be successful. A breakdown,
cyberattack or information security breach could compromise the
confidentiality, integrity and availability of our systems and our
data. Our stock price is volatile and may be affected by a number
of events. Our business performance could affect or limit the
ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock. We may
not be able to access the capital and credit markets on terms that
are favorable to us, or at all.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Trish Hawkins, 805-447-5631
(Media)
Arvind Sood, 805-447-1060
(Investors)
References:
- Cox A, et al. Drugging the undruggable RAS: Mission
Possible?. Nature Reviews Drug Discovery.
2014;13(11):828-851.
- Fernandez-Medarde A, Santos E.
Ras in Cancer and Developmental Diseases. Genes
Cancer. 2011;2(3):344-358.
- Hobbs G, Wittinghofer A, Der C. Selective Targeting of the KRAS
G12C Mutant: Kicking KRAS When It's Down. Cancer Cell.
2016;29(3):251-253.
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SOURCE Amgen