Amgen Launches Biomarker Assist™, a Program To Help More Patients With Non-Small Cell Lung Cancer Gain Access To Biomarker Testing

THOUSAND OAKS, Calif., April 19, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the launch of Biomarker Assist™, a program to help more patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) gain access to biomarker testing. Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment. Through Biomarker Assist™, eligible patients may save on biomarker testing.

Professional clinical guidelines, including the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), the Association for Molecular Pathology (AMP) and the American Society of Clinical Oncology (ASCO) recommend comprehensive biomarker testing of multiple genes simultaneously—for both actionable and emerging biomarkers—for patients diagnosed with advanced NSCLC regardless of clinical characteristics such as age, race or smoking status.¹

"Approximately half of all patients with non-small cell lung cancer have oncogene biomarkers, yet despite the integral role that biomarkers play in lung cancer to identify patients who may benefit from targeted therapies, many patients are not tested," said Darryl Sleep, M.D., chief medical officer and senior vice president of Global Medical at Amgen.^2,3 "Amgen is excited to launch Biomarker Assist™, a patient support program that demonstrates our commitment to closing the gap in testing rates. Based on a patient's biomarker status, clinicians and patients can make informed decisions on personalized treatment plans and targeted therapies which have significantly improved the prognosis for many patients."

NSCLC is a heterogeneous disease associated with different driver mutations that are responsible for cancer development and growth.¹ There are currently seven different actionable driver mutations in NSCLC with a number of emerging therapies under investigation for other molecular mutational drivers, including KRAS.

"The advancement of personalized medicine has transformed the treatment of lung cancer leading to the development of innovative targeted immunotherapies and personalized treatment plans for patients," said Jennifer C. King, Ph.D., chief scientific officer of GO2 Foundation for Lung Cancer. "Over the last decade, the cancer community has learned a great deal about precision medicine, particularly for non-small cell lung cancer, but if patients aren't getting comprehensive biomarker testing, then they are less likely to benefit from all of the therapeutic advancements. We welcome programs like Amgen's Biomarker Assist™ because we need support from all stakeholders, including industry, so that comprehensive biomarker testing becomes universal for everyone who is diagnosed with lung cancer."

About Amgen Biomarker Assist™
Biomarker Assist™ is comprised of two programs: the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test (SGT) Program. The NGS Affordability Program offers assistance to eligible patients with out-of-pocket costs for a comprehensive biomarker panel for patients who have advanced or metastatic (stage IV) NSCLC. This panel must include the KRAS gene. The program is for commercially or privately insured patients. The KRAS Single Gene Test Program will provide a KRAS Mutation Analysis at no cost to any eligible patient, regardless of a patient's results and insurance. Patients will receive results from participating NeoGenomics Laboratories. Both programs are valid for testing performed through Dec. 31, 2021. To learn more about eligibility for these programs and read the full Terms and Conditions, visit www.BiomarkerAssist.com or contact 1-888-4ASSIST with questions.

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.

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 any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), or the integration of Otezla^® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as 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, effects of pandemics or other widespread health problems 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 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.

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CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)

References

1. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker Testing for Patients With Advanced Non-Small Cell Lung Cancer: Real-World Issues and Tough Choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542.
2. Pakkala S, et al. JCI Insights. 2018;3:e120858.
3. Gutierrez ME, Choi K, Lanman RB, et al. Genomic Profiling of Advanced Non-Small Cell Lung Cancer in Community Settings: Gaps and Opportunities. Clin Lung Cancer. 2017;18:651-659.

SOURCE Amgen

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