Application is for Patients With Previously Treated Non-Small
Cell Lung Cancer (NSCLC) With the KRAS
G12C Mutation
EU Application Follows Sotorasib New Drug Application
Submission to U.S. FDA Announced Last Week
THOUSAND OAKS, California,
Dec. 22, 2020 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced submission of a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for sotorasib, an investigational KRASG12C
inhibitor, for the treatment of adult patients with previously
treated KRAS G12C-mutated locally advanced or metastatic
non-small cell lung cancer (NSCLC).
"Just over two years since the first patient was dosed,
sotorasib is now on track to potentially be the first approved
targeted therapy for patients with previously treated NSCLC
harboring the KRAS G12C mutation," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "With this submission to
EMA, Amgen is continuing to rapidly advance the KRASG12C
inhibitor clinical program to bring this innovative potential
therapy to patients globally as quickly as possible."
KRAS G12C is the most common KRAS mutation in
NSCLC.1 Approximately 13% of patients with NSCLC harbor
the KRAS G12C mutation and each year approximately 33,000
new patients in the EU-27 are diagnosed with KRAS
G12C-mutated
NSCLC.1,2 There is a
high unmet need and poor outcomes in the second-line treatment of
KRAS G12C-driven NSCLC and, currently, there are no KRAS
G12C targeted therapies approved.
3,4,5
The submission is supported by positive Phase 2 results in
patients with locally advanced or metastatic NSCLC with KRAS
G12C mutation from the CodeBreaK 100 clinical study, whose
cancer had progressed despite prior treatment with chemotherapy
and/or immunotherapy. In the Phase 1 study, treatment with
sotorasib provided durable anticancer activity with a positive
benefit-risk profile.6 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.7 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 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 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.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
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and uncertainties, including those discussed below and more fully
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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 European Cancer Information System. Data
explorer. Incidence and mortality 2020. EU-27. Available at:
https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-AE27$2-All$4-1,2$3-All$6-0,85$5-2008,2008$7-7,8$CEstByCancer$X0_8-3$CEstRelativeCanc$X1_8-3$X1_9-AE27
Accessed December 2020.
2 Lung Cancer Europe. Types of lung cancer and
staging. Available at:
https://www.lungcancereurope.eu/lung-cancer/types-of-lung-cancer-and-staging/
Accessed December 2020.
3 Aggarwal S, et al. Presented at: The European
Society for Medical Oncology; September
2020; Virtual Congress. Poster 1339P.
4 McCormick F. K-Ras protein as a drug target. J
Mol Med (Berl). 2016;94(3):253-258.
5 Román M, Baraibar I, López I, et al. KRAS
oncogene in non-small cell lung cancer: clinical perspectives on
the treatment of an old target. Mol Cancer.
2018;17(1):33.
6 Hong DS, et al. N Engl J Med. 2020;
383:1207-1217.
7 Kim D, et al. Cell.
2020;183 :850-859.
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