THOUSAND OAKS, Calif.,
Jan. 12, 2021 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced new data from its oncology
pipeline in lung cancer will be presented during the 2020 World
Conference on Lung Cancer (WCLC) hosted by the International
Association for the Study of Lung Cancer taking place virtually
from Jan. 28-31, 2021.
Phase 2 data from the CodeBreaK 100 clinical study, evaluating
investigational sotorasib (AMG 510) in patients with KRAS
G12C-mutated advanced non-small cell lung cancer (NSCLC) will
be presented as part of the WCLC Presidential Symposium from
3:50-4 p.m. PST on Friday, Jan. 29.
Additionally, updated Phase 1 data from AMG 757, an investigational
first-in-class BiTE® molecule that is uniquely designed
to target delta-like ligand 3 (DLL3) in small cell lung cancer
(SCLC), will also be presented in an oral presentation.
"We are incredibly excited to present the first complete Phase 2
non-small cell lung cancer data set for an investigational
KRASG12C inhibitor, including novel biomarker analyses,"
said David M. Reese, M.D., executive
vice president of Research and Development at Amgen. "This is an
historic moment not only for us, but for the scientific community
working on the 40-year quest to target KRAS, one of cancer
research's toughest challenges. Additionally, following recent
regulatory submissions to the FDA and European Medicines Agency, we
remain focused on rapidly bringing this potential foundational KRAS
G12C therapy to patients with advanced non-small cell lung cancer
harboring this mutation."
"KRAS G12C is one of the most common driver mutations in
non-small cell lung cancer; each year approximately 25,000 new
patients in the U.S. are diagnosed with KRAS G12C-mutated non-small
cell lung cancer," said Suresh S.
Ramalingam, M.D., deputy director of Winship Cancer
Institute at Emory University in
Atlanta. "The sotorasib data that
will be presented at WCLC represents an important step forward in
addressing the high unmet need for patients with this
mutation."
Abstracts not featured in the Presidential Symposium are
available at https://wclc2020.iaslc.org/.
Learn more about how Amgen Oncology is advancing its
pioneering science with the relentless pursuit of innovative
modalities and unique pathways for cancer patients and their
families at AmgenOncology.com/medical.
Clinical Abstracts and Presentation Times:
- Registrational Phase 2 Trial of Sotorasib in KRAS p.G12C
Mutant NSCLC: First Disclosure of the CodeBreaK 100 Primary
Analysis
Presentation #PS01.07, Presidential Symposium,
Saturday, Jan. 30 from 7:50-8 a.m. SGT / Friday,
Jan. 29 from 3:50-4 p.m.
PST
- Clinical Characteristics and Outcomes in Advanced KRAS
Mutant NSCLC – A Multi-Centre Collaboration in Asia (ATORG-005)
Presentation #MA04.06,
Mini-oral Presentation, Friday, Jan.
29 from 5:15-5:20 p.m. SGT /
Friday, Jan. 29 from 1:15-1:20 a.m. PST
- A Phase 1 Study of AMG 757, Half-Life Extended Bispecific
T-Cell Engager (BiTE®) Immune Therapy
Against DLL3, in SCLC
Presentation #OA11.03, Oral
Presentation, Sunday, Jan. 31 from
3:30-3:40 p.m. SGT / Saturday, Jan. 30 from 11:30-11:40 p.m. PST
- AMG 757, a Half-Life Extended Bispecific T-Cell Engager (HLE
BiTE® Immuno-Oncology Therapy)
Targeting DLL3, for the Treatment of Small Cell Lung
Cancer
Presentation #P15.01, e-Poster Presentation
Amgen Webcast Investor Call
Amgen will host a
webcast call for the investment community in conjunction
with WCLC 2020. On Friday, Jan. 29, 2021 at 5 p.m.
PST, 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 trial
investigators, will discuss the registrational Phase 2 NSCLC data
being presented on the Company's investigational
KRASG12C inhibitor sotorasib.
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 Sotorasib
Amgen has taken on one of the toughest
challenges of the last 40 years in cancer research by developing
sotorasib, an investigational
KRASG12C inhibitor.1 Sotorasib was the
first KRASG12C inhibitor to enter the clinic and is
being studied in the broadest clinical program exploring 10
combinations with global sites spanning four continents. In just
over two years, the sotorasib clinical program CodeBreaK has
established the deepest clinical data set with nearly 700 patients
studied across 13 tumor types.
Sotorasib has demonstrated a positive benefit-risk profile with
fast, deep and durable anticancer activity in patients with
advanced non-small cell lung cancer (NSCLC) harboring the KRAS
G12C mutation with a once daily oral formulation. Promising
responses have also been observed in multiple other solid
tumors.1
About CodeBreaK
The CodeBreaK clinical development
program for Amgen's investigational drug sotorasib is designed
to treat patients with an advanced solid tumor with
the KRAS G12C mutation 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 must have received
a prior line of systemic anticancer therapy, consistent with their
tumor type and stage of disease. The primary endpoint for the Phase
2 study was centrally assessed objective response rate. The Phase 2
trial in NSCLC enrolled 126 patients, 123 of whom had centrally
evaluable lesions by RECIST 1.1 at baseline. The Phase 2 trial in
colorectal cancer (CRC) is fully enrolled and topline results are
expected in 2021.
A global Phase 3 randomized active-controlled study comparing
sotorasib to docetaxel in KRAS G12C-mutated NSCLC patients
(CodeBreaK 200) is currently recruiting. Amgen also has more than
10 Phase 1b sotorasib combination
studies across various advanced solid tumors (CodeBreaK 101) open
for enrollment.
For information, please visit www.codebreaktrials.com.
About
BiTE® Technology
BiTE®
(bispecific T cell engager) technology is a targeted
immuno-oncology platform that is designed to engage a patient's own
T cells to any tumor-associated 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-associated 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, and/or to produce any such antibodies 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. Further, any
scientific information discussed in this news release relating to
new indications for our products is preliminary and investigative
and is not part of the labeling approved by the U.S. Food and Drug
Administration for the products. The products are not approved for
the investigational use(s) discussed in this news release, and
no conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
References
1. Kim D, et al. Cell.
2020;183 :850-859.
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SOURCE Amgen