Press Release

THOUSAND OAKS, Calif., Sept. 8, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated 世界杯直播频道 KRAS G12C-mutated 观看比赛直播 世界杯比赛时间 solid 世界杯比赛时间 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 观看比赛直播 with non-small cell 2026世界杯直播赛程 lung cancer (NSCLC) continued to 2026世界杯直播赛程 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 2026世界杯直播赛程 世界杯比赛时间 世界杯直播频道 by 2026世界杯直播赛程 the International Association for the Study of Lung Cancer.

Initial data from the Phase 1 study were presented at the 55th Annual 世界杯直播频道 Meeting of the American Society of Clinical Oncology (ASCO) earlier this year. The additional follow-up in a larger group of patients being presented 世界杯比赛时间 at 世界杯比赛时间 WCLC includes a subset of 34 NSCLC 2026世界杯直播赛程 patients enrolled, with 23 of the patients being evaluable 世界杯比赛时间 for efficacy. Thirteen of the evaluable patients 观看比赛直播 received the target dose of 960 mg 观看比赛直播 once daily, of which seven 世界杯直播频道 世界杯比赛时间 世界杯直播频道 2026世界杯直播赛程 世界杯比赛时间 观看比赛直播 世界杯直播频道 (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 世界杯直播频道 data 世界杯比赛时间 reinforce the earlier 世界杯比赛时间 世界杯直播频道 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. 世界杯比赛时间 "We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance 世界杯比赛时间 its development program both as monotherapy and in combination."

Among the 34 NSCLC patients 世界杯直播频道 enrolled, there were no observed dose-limiting 观看比赛直播 toxicities and 观看比赛直播 no adverse events leading to discontinuation. Twenty-seven of these 世界杯直播频道 patients remain on treatment. Of the 34 世界杯直播频道 patients, only 观看比赛直播 世界杯比赛时间 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 观看比赛直播 Ramaswamy Govindan, M.D., principal investigator and professor at Washington University 世界杯比赛时间 世界杯比赛时间 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 2026世界杯直播赛程 观看比赛直播 世界杯直播频道 2026世界杯直播赛程 previously treated KRAS G12C-mutated NSCLC."

Additional data on 2026世界杯直播赛程 AMG 510 will be presented at the 世界杯直播频道 European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain from Sept. 27-Oct. 1.

About the 世界杯直播频道 Phase 1 观看比赛直播 Study

The Phase 世界杯比赛时间 1, first-in-human, open-label multicenter study enrolled patients with KRAS G12C mutant solid tumors. Eligible patients 世界杯直播频道 were heavily pretreated with at least two or more prior lines of treatment, consistent 世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 with their tumor type 世界杯比赛时间 and stage of 世界杯直播频道 disease. The primary endpoint is safety, and key secondary endpoints 2026世界杯直播赛程 include 世界杯直播频道 pharmacokinetics, objective response rate (assessed every six weeks), duration of response and 2026世界杯直播赛程 世界杯比赛时间 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. ^1,2Within this family, KRAS is the most prevalent 世界杯直播频道 variant and is particularly 世界杯直播频道 common in solid tumors. 世界杯比赛时间 ²A specific mutation known as KRAS G12C accounts for approximately 13% 世界杯比赛时间 of non-small cell lung cancers, 3-5% of colorectal cancers and one to two percent of numerous other solid 世界杯比赛时间 tumors. ³Approximately 30,000 patients are diagnosed each year in the United States with KRAS G12C-driven cancers. ⁴KRASG12C has 世界杯直播频道 been considered "undruggable" 观看比赛直播 due to a lack of traditional 世界杯直播频道 small molecule binding pockets on the protein. Amgen is exploring the 观看比赛直播 potential of KRAS^G12C inhibition across a broad variety of tumor types.

About Amgen Oncology

Amgen Oncology 2026世界杯直播赛程 is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer 观看比赛直播 patients and their families. Our research drives us to understand the disease 观看比赛直播 世界杯比赛时间 in the context of the patient's life – not 世界杯直播频道 just their cancer journey – so they 世界杯直播频道 can 观看比赛直播 take control of their lives.

For the last four decades, we have 世界杯直播频道 been 世界杯直播频道 dedicated to discovering the firsts that matter 观看比赛直播 in oncology and to finding 世界杯比赛时间 ways to 世界杯直播频道 reduce 世界杯比赛时间 the 世界杯比赛时间 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 世界杯比赛时间 keep them at the center of everything we do.  

For more information, follow 世界杯比赛时间 us on http://www.twitter.com/amgenoncology.

About Amgen

Amgen is committed to unlocking 世界杯直播频道 2026世界杯直播赛程 the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins 观看比赛直播 观看比赛直播 世界杯直播频道 世界杯直播频道 by using tools like advanced human genetics to unravel 世界杯直播频道 the complexities of disease 世界杯比赛时间 and 世界杯直播频道 understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 世界杯直播频道 its expertise 世界杯直播频道 to strive for solutions that improve health outcomes and dramatically improve people's 2026世界杯直播赛程 lives. A biotechnology pioneer since 1980, Amgen 世界杯直播频道 2026世界杯直播赛程 世界杯直播频道 has grown to be one of the world's leading independent biotechnology 世界杯比赛时间 companies, has reached millions of patients in more than 100 countries and regions worldwide 世界杯比赛时间 and 世界杯比赛时间 is developing a pipeline of medicines with breakaway potential.

For more information, 世界杯比赛时间 visit http://www.amgen.com and follow us on 世界杯比赛时间 http://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 2026世界杯直播赛程 than 2026世界杯直播赛程 statements of historical fact, are statements that could 世界杯直播频道 be deemed 2026世界杯直播赛程 世界杯直播频道 forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or 世界杯直播频道 世界杯直播频道 观看比赛直播 世界杯比赛时间 practices, customer and prescriber patterns or practices, reimbursement activities and outcomes 世界杯比赛时间 and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including 世界杯直播频道 世界杯比赛时间 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 世界杯比赛时间 subsequent periodic reports on Form 世界杯直播频道 世界杯直播频道 世界杯比赛时间 10-Q and current reports on  Form 8-K. Unless otherwise noted, Amgen is providing this information as of the 2026世界杯直播赛程 date 2026世界杯直播赛程 of this news release and does not undertake any obligation to update any forward-looking statements 世界杯直播频道 2026世界杯直播赛程 世界杯直播频道 2026世界杯直播赛程 contained in this document as a result 世界杯比赛时间 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 观看比赛直播 世界杯比赛时间 世界杯直播频道 products cannot be guaranteed and movement from concept to product 观看比赛直播 is uncertain; consequently, there can be no guarantee that any particular product candidate or 观看比赛直播 development of a new indication for an 世界杯比赛时间 existing 世界杯比赛时间 世界杯直播频道 product will be successful and become a commercial 世界杯直播频道 product. Further, preclinical results do not guarantee safe and effective performance of product 世界杯比赛时间 candidates in humans. The complexity of the human body cannot 观看比赛直播 be perfectly, or 观看比赛直播 sometimes, even adequately modeled by computer or cell culture systems or animal models. The length 世界杯直播频道 of time that it takes for us to complete clinical trials and obtain regulatory approval for 世界杯比赛时间 世界杯直播频道 世界杯比赛时间 product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, 世界杯比赛时间 regulatory authorities may question the sufficiency for approval of the trial 世界杯直播频道 世界杯直播频道 endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint 世界杯直播频道 ventures. Product candidates that are derived from relationships may be subject 世界杯比赛时间 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 观看比赛直播 entering into such relationship. Also, we or others could identify safety, side effects or 世界杯比赛时间 manufacturing problems with our 世界杯比赛时间 products, including our devices, after they 世界杯直播频道 are on the 观看比赛直播 market.

Our results may be affected by 观看比赛直播 our ability to successfully market both new and existing 世界杯直播频道 products domestically and internationally, clinical and 2026世界杯直播赛程 regulatory developments involving current 世界杯比赛时间 and future products, sales 世界杯直播频道 growth of recently launched 2026世界杯直播赛程 products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. 世界杯比赛时间 In addition, sales of our products 世界杯比赛时间 are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party 世界杯直播频道 payers, including governments, private insurance plans and managed care providers and may be 世界杯直播频道 世界杯直播频道 世界杯比赛时间 世界杯直播频道 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 世界杯直播频道 观看比赛直播 世界杯直播频道 other operations are 世界杯比赛时间 subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. 世界杯比赛时间 世界杯比赛时间 世界杯直播频道 2026世界杯直播赛程 In 世界杯比赛时间 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 世界杯比赛时间 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 世界杯直播频道 our patents and patent 世界杯直播频道 世界杯直播频道 applications may be challenged, invalidated or circumvented by our competitors, 观看比赛直播 or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 世界杯直播频道 2026世界杯直播赛程 世界杯直播频道 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 2026世界杯直播赛程 sales of certain 世界杯比赛时间 世界杯比赛时间 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 世界杯直播频道 世界杯比赛时间 of our current products and product candidate development. 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 观看比赛直播 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, 世界杯比赛时间 观看比赛直播 medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our 2026世界杯直播赛程 distributors, customers and payers have 2026世界杯直播赛程 substantial purchasing leverage in their dealings with 2026世界杯直播赛程 世界杯直播频道 2026世界杯直播赛程 us. The discovery of significant problems with a product similar to one of our products 世界杯比赛时间 that implicate an entire class of products could 2026世界杯直播赛程 have a material adverse effect on sales of the affected products and on 2026世界杯直播赛程 观看比赛直播 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 世界杯直播频道 security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our 世界杯比赛时间 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 世界杯比赛时间 our common stock. We may not be able to access the capital and credit markets 世界杯比赛时间 on terms that are favorable 世界杯比赛时间 to us, or at all.

The scientific information discussed in this news release relating to new indications for our products 世界杯直播频道 is 世界杯比赛时间 preliminary and investigative and is not part of the labeling approved 世界杯直播频道 by the European 世界杯直播频道 Medicines Agency 世界杯直播频道 for 观看比赛直播 世界杯比赛时间 the products. The products are not approved for the investigational use(s) discussed in this news release, and no 观看比赛直播 conclusions 世界杯比赛时间 can or should be drawn regarding the safety or effectiveness of the products for these uses.

1. 1.Cox A, et al. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov. 2014 Nov;13(11):828-51.
2. Fernandez-Medarde A, Santos E. RAS in cancer and developmental 世界杯比赛时间 diseases. Genes Cancer. 2011 Mar;2(3):344-58.
3. 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. 4.Stephen AG, et al. Dragging RAS back in the ring. 世界杯直播频道 Cancer Cell. 2014 Mar 17;25(3):272-81.