54% of 13 Evaluable Non-Small Cell Lung Cancer Patients
Experienced a Partial Response at the Target Dose of 960 mg in the
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Ongoing Phase 1 Study
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46% of Patients had Stable Disease for a Disease Control Rate of
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100% at the Target Dose
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FDA Grants AMG 510 Fast Track Designation for Previously Treated
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Metastatic NSCLC With KRAS G12C Mutation
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THOUSAND OAKS, Calif. (Sept. 8, 2019) — Amgen (NASDAQ:AMGN) today announced new
data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated
KRAS G12C-mutated solid tumors. AMG 510 is a first-in-class investigational oral therapy that is
designed to selectively and irreversibly target the KRASG12C protein. The additional follow-up in a
larger group of patients with non-small cell lung cancer (NSCLC) continued to show anti-tumor
activity with no dose-limiting toxicities. These data are being presented during an oral presentation
at IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International
Association for the Study of Lung Cancer.
Initial data from the Phase 1 study were presented at the 55th Annual Meeting of the American
Society of Clinical Oncology (ASCO) earlier this year. The additional follow-up in a larger group
of patients being presented at WCLC includes a subset of 34 NSCLC patients enrolled, with 23
of the patients being evaluable for efficacy. Thirteen of the evaluable patients received the target
dose of 960 mg once daily, of which seven (54%) achieved a partial response at one or more
timepoints and six (46%) achieved stable disease, for a disease control rate of 100%.
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“These new data reinforce the earlier positive response rate we shared at ASCO in more non-
small cell lung cancer patients receiving AMG 510,†said David M. Reese, M.D., executive vice
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president of Research and Development at Amgen. “We remain enthusiastic about the promise
of AMG 510 and continue to rapidly advance its development program both as monotherapy and
in combination.â€
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AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL
INVESTIGATIONAL KRASG12C INHIBITOR AMG 510
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Among the 34 NSCLC patients enrolled, there were no observed dose-limiting toxicities and no
adverse events leading to discontinuation. Twenty-seven of these patients remain on treatment.
Of the 34 patients, only nine (26.5%) reported treatment-related adverse events (TRAEs) of grade
1 or 2. Three patients reported grade 3 TRAEs (anemia and diarrhea). There were no grade 4 or
higher TRAEs.
“There is a need for targeted treatments for specific driver mutations of cancer that do not have
an approved therapy,†said Ramaswamy Govindan, M.D., principal investigator and professor at
Washington University School of Medicine in St. Louis. “These data continue to show encouraging
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anti-tumor activity with AMG 510, underscoring the potential to close the treatment gap for non-
small cell lung cancer patients with previously treated KRAS G12C-mutated NSCLC.â€
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Additional data on AMG 510 will be presented at the European Society for Medical Oncology
(ESMO) 2019 Congress in Barcelona, Spain from Sept. 27-Oct. 1.
About the Phase 1 Study
The Phase 1, 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 is safety,
and key secondary endpoints include pharmacokinetics, 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.
About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently
mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant
and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C accounts
for approximately 13% of non-small cell lung cancers, 3-5% of colorectal cancers and one to two
percent of numerous other solid tumors.3 Approximately 30,000 patients are diagnosed each year
in the United States with KRAS G12C-driven cancers.4 KRASG12C has been considered
“undruggable†due to a lack of traditional small molecule binding pockets on the protein. Amgen
is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.
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.
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AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL
INVESTIGATIONAL KRASG12C INHIBITOR AMG 510
Page 3
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 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 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
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AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL
INVESTIGATIONAL KRASG12C INHIBITOR AMG 510
Page 4
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. 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 acquire other companies or products and to integrate the operations of
companies 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 relating to new indications for our
products is preliminary and investigative and is not part of the labeling approved by the European
Medicines Agency 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.
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CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (Media)
Arvind Sood, 805-447-1060 (Investors)
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References
1. Cox A, et al. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov.
2014 Nov;13(11):828-51.
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AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL
INVESTIGATIONAL KRASG12C INHIBITOR AMG 510
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2. Fernandez-Medarde A, Santos E. RAS in cancer and developmental diseases. Genes
Cancer. 2011 Mar;2(3):344-58.
3. Lipford, JR. Pre-clinical development of AMG 510: the first inhibitor of KRASG12C in
clinical testing. Oral presentation at AACR 2019, Atlanta, GA. March 29-April 3, 2019.
4. Stephen AG, et al. Dragging RAS back in the ring. Cancer Cell. 2014 Mar 17;25(3):272-
81.