THOUSAND OAKS, Calif.,
Dec. 16, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced submission of a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib,
an investigational KRASG12C inhibitor for the treatment
of patients with KRAS G12C-mutated locally advanced or
metastatic non-small cell lung cancer (NSCLC), as determined by an
FDA-approved test, following at least one prior systemic
therapy.
"Sotorasib was the first KRASG12C inhibitor to enter
the clinic and now is on track to potentially be the first approved
targeted therapy for patients with advanced NSCLC harboring the
KRAS G12C mutation. In the U.S., about 13% of patients with
NSCLC have the KRAS G12C mutation and face a significant
unmet need," said David M. Reese,
M.D., executive vice president of Research and Development at
Amgen. "This submission, along with these other important
regulatory achievements, underscore Amgen's commitment to bringing
this potential treatment option to patients as quickly as
possible."
The NDA is being reviewed by the FDA under its Real-Time
Oncology Review (RTOR) pilot program, which aims to explore a more
efficient review process that ensures safe and effective treatments
are made available to patients as early as
possible.1
The submission is supported by positive Phase 2 results in
patients with locally advanced or metastatic NSCLC from the
CodeBreaK 100 clinical study, whose cancer had progressed despite
prior treatment with chemotherapy and/or immunotherapy. In the
study, treatment with sotorasib provided durable anticancer
activity with a positive benefit-risk profile.2 These
results will be presented at the International Association for the
Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer
(WCLC) Presidential Symposium in January
2021.
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.3
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 across four
continents. In just over two years, the sotorasib clinical program
has established the deepest clinical data set with more than 600
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 NSCLC harboring the KRAS G12C mutation with a once
daily oral formulation. Promising responses have also been
observed in multiple other solid tumors.
KRAS G12C is the most common KRAS mutation in
NSCLC.4,5 In the U.S., about 13% of patients
with NSCLC harbor the KRAS G12C mutation.6 There
is a high unmet need and poor outcomes in the second-line treatment
of KRAS G12C-driven NSCLC and, currently, there are no
KRASG12C targeted therapies approved.7
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 600 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-mutated 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 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 patients with KRAS
G12C-mutated NSCLC (CodeBreaK 200) is currently
recruiting. Amgen also has several Phase 1b combination studies across various advanced
solid tumors (CodeBreaK 101) open for enrollment.
For information, please visit www.codebreaktrials.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.
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
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including any statements on the outcome, benefits and synergies of
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(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,
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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
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any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
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No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
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Our results may be affected by our ability to successfully
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for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
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health threat, such as COVID-19, and the public and governmental
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The scientific information discussed in this news release
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Such product candidates are not approved by the U.S. Food and Drug
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(Media)
Jessica Akopyan, 805-447-0974
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
1 U.S. Food and Drug Administration. Real Time
Oncology Review
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
. Accessed November 20, 2020.
2 Amgen Data on File. 2020.
3 Kim D, et al. Cell.
2020;183 :850-859.
4 Pakkala S, et al. JCI Insight.
2018;3:e120858.
5 Arbour KC, et al. Clin Cancer Res.
2018;24:334-340.
6 Amgen, Data on File. 2020.
7 Aggarwal S, et al. Presented at: The European
Society for Medical Oncology; September
2020; Virtual Congress. Poster 1339P.
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SOURCE Amgen