THOUSAND OAKS, Calif.,
Sept. 16, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) announced today that data from its oncology pipeline
in solid tumors will be presented during the European Society of
Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020.
Amgen will present new data for AMG 510 (proposed INN:
sotorasib) and AMG 160 during two oral presentations. Data from the
study of sotorasib, Amgen's investigational KRASG12C
inhibitor, will showcase Phase 1 clinical results on durability of
clinical benefit in patients with non-small cell lung cancer
(NSCLC). Additionally, data from Amgen's bispecific T cell engager
(BiTE®) platform will feature preliminary safety and
efficacy findings from the ongoing Phase 1 study of AMG 160, an
investigational half-life extended BiTE immuno-oncology therapy
targeting prostate-specific membrane antigen (PSMA). Abstracts will
be released on Saturday, Sept. 19,
and will be followed by oral presentations (sotorasib, Sunday Sept. 20 and AMG 160, Monday Sept. 21) that will highlight more recent
data.
"During ESMO, we will highlight our pioneering work in two key
areas of oncology research – KRAS inhibition and BiTE
therapies," said David M. Reese,
M.D., executive vice president of Research and Development at
Amgen. "Clinicians will be presenting updated data from the first
and largest Phase 1 human clinical study of an investigational
KRASG12C inhibitor, sotorasib -- now the first
KRASG12C inhibitor to advance to a Phase 3 study. In
addition, early and encouraging data from our BiTE platform in the
solid tumor setting will be presented. Our data at ESMO underscore
our unique approach to harnessing the human biology of cancer to
alter the course of cancer care for patients who need it most."
Learn more about Amgen's development of innovative medicines for
novel targets in difficult-to-treat solid tumors at
AmgenOncology.com.
Key Clinical Abstracts and Presentation Times
(Pipeline):
- Durability of Clinical Benefit and Biomarkers in Patients
(pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Treated With
AMG 510 (sotorasib)*
Presentation #1257O, Proffered Paper
Session, Sunday, Sept. 20, 2020, from
2:25 p.m. – 2:37 p.m. CEST / 5:25
a.m. – 5:37 a.m. PDT
- Results From a Phase 1 Study of AMG 160, a Half-Life
Extended (HLE), PSMA-Targeted, Bispecific T Cell Engager
(BiTE®) Immune Therapy for Metastatic
Castration-Resistant Prostate Cancer (mCRPC)
Presentation #609O, Proffered Paper Session, Monday, Sept. 21, 2020, from 2:25 p.m. – 2:37 p.m.
CEST / 5:25 a.m. –
5:37 a.m. PDT
Amgen Webcast Investor Call
Amgen will host two webcast calls for the investment community in
conjunction with the ESMO Virtual Congress 2020. On Sunday, Sept.
20, 2020, at 11:00 a.m. PDT, 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 discuss Phase 1 data being presented on the Company's
investigational KRASG12C inhibitor sotorasib (AMG 510).
On Monday, Sept. 21, at 1:00 p.m. PDT, David M.
Reese, M.D., along with members of Amgen's clinical
development team, will discuss the Phase 1 data being presented on
the Company's investigational half-life extended bispecific T-cell
engager (BiTE®) immuno-oncology therapy targeting
prostate-specific membrane antigen (PSMA).
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.
To learn more about Amgen's innovative pipeline with
diverse modalities and genetically validated targets, please
visit www.AmgenOncology.com.
About CodeBreaK
The CodeBreaK clinical trial program for Amgen's
investigational drug sotorasib is designed to treat patients with
multiple KRAS G12C-mutant solid tumors and address the
longstanding unmet medical need for these cancers.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label
multicenter study, enrolled patients with KRAS
G12C-mutant solid tumors. Eligible patients were heavily
pretreated with at least two or more prior lines of treatment,
consistent with their tumor type and stage of disease. The primary
endpoint for the Phase 1 study is safety, and key secondary
endpoints include objective response rate (assessed every six
weeks), duration of response and progression-free survival.
Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg
and 960 mg, taken orally once a day.
Amgen's single-arm Phase 2 trials in both non-small cell lung
cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK
100) are now fully enrolled. The potentially registrational
Phase 2 trial in NSCLC is on track for data readout later in 2020
and a Phase 3 trial comparing sotorasib with docetaxel in NSCLC has
begun recruiting. The Phase 2 CRC trial is expected to
have a data readout in early 2021.
Amgen is currently enrolling six Phase 1b combination studies across various advanced
solid tumors (CodeBreaK 101). In addition, a randomized global
Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been
initiated. Additional information about CodeBreaK clinical
trials can be found at http://www.codebreaktrials.com.
About BiTE® Technology
BiTE® (bispecific T cell engager) technology is a
targeted immuno-oncology platform that is designed to engage
patient's 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 has
a goal of leading 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. To learn more about BiTE technology, visit
www.AmgenBiTETechnology.com.
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 patient's 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 any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other
company, including BeiGene Ltd. or any collaboration or potential
collaboration in pursuit of therapeutic antibodies against COVID-19
(including statements regarding such collaboration's, or our own,
ability to discover and develop fully-human neutralizing antibodies
targeting SARS-CoV-2 or antibodies against targets other than
the SARS-CoV-2 receptor binding domain, to potentially prevent or
treat COVID-19), or the Otezla® (apremilast) acquisition
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), as well as 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, effects of
pandemics or other widespread health problems such as the ongoing
COVID-19 pandemic on our business, outcomes, progress, or effects
relating to studies of Otezla as a potential treatment for
COVID-19, 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. Further, 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. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. 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 collaborate with or acquire
other companies, products or technology, and to integrate the
operations of companies or to support the products or technology 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
Trish Rowland, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen