THOUSAND OAKS, Calif.,
Oct. 5, 2020 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced
positive topline Phase 2 results from the CodeBreaK 100
clinical study, evaluating sotorasib (proposed INN for AMG 510) in
126 patients with KRAS G12C-mutant advanced non-small cell
lung cancer (NSCLC), who had failed a median of two prior lines of
anti-cancer therapies (immunotherapy and/or chemotherapy).
Sotorasib demonstrated an objective response rate (primary end
point) consistent with previously reported Phase 1 data in patients
with advanced NSCLC taking the 960 mg daily dose. Other measures of
efficacy, including duration of response, were promising and more
than half of the responders were still on treatment and continuing
to respond as of the data cutoff date. Safety and tolerability were
similar to previously reported data in Phase 1 in patients with
advanced NSCLC.
"Targeting KRAS has been a 40-year quest that has left
patients with limited options. These topline data underscore our
belief in the potential for sotorasib to become the standard of
care for non-small cell lung cancer patients with the KRAS
G12C mutation who remain in need of new treatment options,"
said David M. Reese, M.D., executive
vice president of Research and Development at Amgen. "We now have
more than 500 patients who have been enrolled across clinical
studies, and we are rapidly moving forward with a broad-based
development program, which includes monotherapy studies in
non-small cell lung cancer, colorectal cancer and other solid
tumors harboring the KRAS G12C mutation, as well as a suite
of combination studies. We look forward to discussing the
current results with the U.S. Food and Drug Administration (FDA)
and other regulatory agencies, to determine the best path forward
for sotorasib as a potential treatment for patients with NSCLC
harboring the KRAS G12C mutation."
Detailed results of this potentially registrational Phase 2
clinical study in patients with advanced NSCLC will be submitted to
the IASLC 2020 World Congress on Lung Cancer taking place
January 2021. A global Phase 3
randomized active-controlled confirmatory study
comparing sotorasib to docetaxel in KRAS
G12C-mutant NSCLC patients (CodeBreaK 200) has begun
recruiting.
About KRAS
The RAS gene family, which
has been the subject of almost four decades of research, contains
some of the most frequently mutated oncogenes in human
cancers.1,2 Targeting the KRAS protein, the most
commonly altered family member in solid tumors, has been one of the
toughest challenges in cancer research.1 A specific
mutation known as KRAS G12C, is a major driver of tumor
growth, occurring broadly across solid tumor indications. In the
U.S., about 13% of patients with non-small cell lung cancer harbor
the KRAS G12C mutation.3,4
It is also found in approximately 3-5% of colorectal cancers and
1-2% of numerous other solid tumors, making this among the most
broadly represented mutations across cancer patient
subgroups.5,6,7,8,9.
With the discovery of a unique surface groove in the
KRASG12C protein, Amgen developed and advanced the first
investigational KRASG12C inhibitor into the clinic and
is exploring the potential of KRASG12C inhibition
across multiple tumor types for patients who remain in dire need of
treatment options.1,10
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. As the most advanced KRAS G12C clinical
development program, CodeBreaK has enrolled more than 500 patients
across 13 tumor types since its inception.
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 study enrolled 126
patients, 123 of whom had centrally evaluable lesions by RECIST at
baseline.
Amgen's single-arm Phase 2 trial in colorectal cancer (CRC)
(also part of CodeBreaK 100) is fully enrolled and topline results
are expected in 2021. A global Phase 3 randomized active-controlled
confirmatory study comparing sotorasib to docetaxel in
KRAS G12C-mutant NSCLC patients (CodeBreaK 200) has begun
recruiting. Amgen is also enrolling several Phase 1b combination studies across various advanced
solid tumors (CodeBreaK 101).
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.
To learn more about Amgen's innovative pipeline with diverse
modalities and genetically validated targets, please visit
AmgenOncology.com. 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.
CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060
(investors)
References
1 Cox AD, et al. Nat Rev Drug Discov.
2014;13:828-851.
2 Fernandez-Medarde A, et al. Genes Cancer.
2011;2:344-358.
3 Biernacka A, et al. Cancer Genet.
2016;209:195-198.
4 Stephen AG, et al. Cancer Cell. 2014;25:272-281.
5 Neumann J, et al. Pathol Res Pract.
2009;205:858-862.
6 Jones RP, et al. Br J Cancer. 2017;116:923-929.
7 Wiesweg M, et al. Oncogene. 2019;38:2953-2966.
8 Canon J, et al. Nature. 2019;575:217-223.
9 Zhou L, et al. Med Oncol. 2016;33:32.
10 Ryan MB, et al. Nat Rev Clin
Oncol. 2018;15:709-720.
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