AMGEN ANNOUNCES NEW CLINICAL DATA EVALUATING NOVEL INVESTIGATIONAL KRASG12C INHIBITOR IN LARGER PATIENT GROUP AT WCLC 2019

54% of 13 Evaluable Non-Small Cell Lung Cancer Patients

Experienced a Partial Response at the Target Dose of 960 mg in the

 

Ongoing Phase 1 Study

 

46% of Patients had Stable Disease for a Disease Control Rate of

 

100% at the Target Dose

 

FDA Grants AMG 510 Fast Track Designation for Previously Treated

 

Metastatic NSCLC With KRAS G12C Mutation

 

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%.

 

“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

 

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.”

 

AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL

INVESTIGATIONAL KRASG12C INHIBITOR AMG 510

Page 2

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

 

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.”

 

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.

 

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

 

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.

 

###

 

CONTACT: Amgen, Thousand Oaks

Trish Hawkins, 805-447-5631 (Media)

Arvind Sood, 805-447-1060 (Investors)

 

References

1. Cox A, et al. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov.

2014 Nov;13(11):828-51.

 

AMGEN ANNOUNCES ADDITIONAL CLINICAL DATA EVALUATING NOVEL

INVESTIGATIONAL KRASG12C INHIBITOR AMG 510

Page 5

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.

AMGEN ANNOUNCES NEW CLINICAL DATA EVALUATING NOVEL INVESTIGATIONAL KRASG12C INHIBITOR IN LARGER  PATIENT GROUP AT WCLC 2019

AMGEN ANNOUNCES NEW CLINICAL DATA EVALUATING NOVEL INVESTIGATIONAL KRASG12C INHIBITOR IN LARGER PATIENT GROUP AT WCLC 2019

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