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NICE RECOMMENDS LUMYKRAS™▼(SOTORASIB) FOR LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITHIN THE CANCER DRUGS FUND

Sotorasib Is Indicated As Monotherapy For The Treatment Of Adult Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed On, Or Are Intolerant To, Platinum-Based Chemotherapy And/Or Anti PD-1/PD-L1 Immunotherapy. 1

KRAS G12C Gene Mutation Is Found In Around 1 In 8 Patients With NSCLC 2

CAMBRIDGE, UK – (3rd March 2022) – The National Institute for Health and Care Excellence (NICE) has today published a final appraisal document recommending Lumykras™ (sotorasib) for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy, in accordance with the managed access agreement.1,4,15

Amgen’s first-in-class drug, Sotorasib, was the first new medicine to receive a Conditional Marketing Authorisation* from the Medicines and Healthcare products Regulatory Agency (MHRA) for use across England, Scotland and Wales under Project Orbis.4,5 The treatment, an oral targeted therapy, will now be available to suitable patients in England via the Cancer Drugs Fund, addressing an unmet need in previously treated patients with KRAS G12C NSCLC, a mutation which was previously thought to be “undruggable”.4,5

Lung cancer is the third most common cancer with an estimated 48,000 new cases diagnosed in the UK ever year.7 NSCLC accounts for 85% of lung cancers and approximately 13% of these are thought to have the KRAS G12C mutation.2,6 Sotorasib represents a new treatment option for suitable patients who have had biomarker testing and been identified with this mutation.1,5

Professor Sanjay Popat, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust said: “Sotorasib is a step change for these patients, allowing them to receive daily tablets rather than chemotherapy in the hospital. I’m therefore delighted NICE has approved this drug for patients via the Cancer Drug Fund. Importantly, in parallel the NHS is making excellent progress in molecular analysis of lung cancer patients to find the KRAS G12C mutation and identify those patients who are most likely to benefit from this treatment.”

Dr. Tony Patrikios, Executive Medical Director at Amgen UK and Ireland said: “Sotorasib provides a new treatment option for appropriate patients whose lung cancer is found to have the KRAS G12C mutation. More than half of NSCLC patients have advanced or metastatic disease at diagnosis and outcomes across the UK remain poor7. Amgen is proud of our collaboration with both NHS England and NICE to ensure people living with NSCLC who may benefit from sotorasib can access the medicine without delay.”

Paula Chadwick, Chief Executive of Roy Castle Lung Cancer Foundation said: “This recommendation demonstrates all the hard work that is happening to develop new treatment options for people with lung cancer. The pandemic has had a devastating effect on these patients, potentially denying many of them the chance of an earlier, and possibly life-saving diagnosis. However, the advances in new treatments like sotorasib offer some hope by giving people another treatment option.”

The NICE decision to recommend sotorasib for use in the Cancer Drugs Fund follows an agreement between Amgen and NHS England which has already enabled more than 100 patients to access the medicine following its Conditional Marketing Authorisation by MHRA via Project Orbis.5

The Conditional Marketing Authorisation for sotorasib is based on clinical evidence from the Phase 2 CodeBreaK 100 study which evaluated the drug in 126 patients with KRAS G12C-mutated advanced NSCLC.8 This trial demonstrated an Objective Response Rate ORR (primary end point) of 37.1% (95% confidence interval [CI], 28.6 to 46.2)8, and an Overall Survival OS (secondary end point) of 12.5 months (95% CI, 10.0 to not evaluable)8. Among 46 patients with ORR, the median Duration of Response (DoR) was 10.0 months (95% CI, 1.2 to 11.1). 1

The most common adverse reactions observed with sotorasib were diarrhoea (34%), musculoskeletal pain (31%), nausea (25%), fatigue (21%), hepatotoxicity (19%) and cough (16%). The most common severe (grade ≥ 3) adverse reactions were increased ALT (5%), increased AST (4%), and diarrhoea (4%). The most common adverse reactions leading to permanent discontinuation of treatment were increased ALT (1%), increased AST (1%) and drug-induced liver injury (1%). The most common adverse reactions leading to dose modification were increased ALT (6%), increased AST (6%), and diarrhoea (6%).1

*This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited.

NOTES TO EDITORS

About Sotorasib

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, a KRAS G12C inhibitor. 3,10 Sotorasib was the first KRAS G12C inhibitor to enter the clinic and is being studied in 10 combinations with global sites spanning four continents.11 In just under three years, the CodeBreaK clinical development programme for sotorasib has established a clinical data set with more than 800 patients studied across 13 tumour types to date.12

More information about sotorasib can be found in the Summary of Product Characteristics. 1

About CodeBreaK

The CodeBreaK clinical development programme is designed to study the risk benefit associated with Amgen’s investigational drug sotorasib for patients with an advanced solid tumour with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.9,13

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicentre single arm study, enrolled patients with KRAS G12C-mutant solid tumours.9 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed Objective Response Rate (ORR).9 ORR by blinded Independent Review Committee. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST 1.1 at baseline.8,14

A global Phase 3 randomised active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK) includes sites across the UK.13

About Amgen Oncology

Amgen Oncology is searching for and finding answers to incredibly complex questions that aim to 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 centre of everything we do.

About Amgen in the UK and Ireland

Amgen is committed to the relentless pursuit of breakthroughs and making a sustainable contribution to healthcare. A biotechnology pioneer since 1980, Amgen serves patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.

Amgen develops innovative medicines in cancer and long-term conditions by using advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. As one of the most forward-thinking and innovative biotech companies, Amgen’s growing portfolio of medicines tackle some of the biggest healthcare burdens facing society today.

The Amgen community in the UK and Ireland is one of Amgen’s largest outside of the company headquarters in California and is a European hub for research and development. More than 500 people at Amgen in the UK and Ireland contribute to the journey that turns molecules into medicines.

For more information, visit www.amgen.co.uk

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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 acquisitions (including anticipated 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, 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 tolerable and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modelled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain licence 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 authorisation 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 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. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. 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 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, 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 collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology 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. Global economic conditions may magnify certain risks that affect our business. 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 favourable to us, or at all.

Contact

Name: Tom Cook
Telephone: +44 (0) 1895 525014
Email: tcook01@amgen.com

Name: Rosanna Forrest (Analogy)
Telephone: +44 (0) 7714 755742
Email: rosanna.forrest@analogycomms.com

References

1. Amgen. LUMYKRAS Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12871. Accessed March 2022.
2. Biernacka A, et al. Cancer Genet. 2016;209:195-198.
3. Cox AD, et al. Nat Rev Drug Discov. 2014;13:828–51.
4. Amgen internal information.
5. NHS England. Lung cancer patients to get breakthrough drug on NHS. https://www.england.nhs.uk/2021/09/lung-cancer-patients-to-get-breakthrough-drug-on-nhs/. Accessed March 2022.
6. Cancer Research UK. Types of Lung Cancer. Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types. Accessed March 2022.
7. Cancer Research UK. Lung Cancer Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer#heading-Two. Accessed March 2022.
8. Skoulidis F, et al. New England Journal of Medicine. 2021. 384:2371-2381 DOI: 10.1056/NEJMoa2103695.
9. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03600883. Accessed March 2022.
10. Canon J, et al. Nature. 2019;575:217-223.
11. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/results?cond=&term=codebreak&cntry=&state=&city=&dist=&Search=Search Accessed March 2022.
12. Amgen Data on File.
13. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT04303780. Accessed March 2022.
14. Li BT, et al. Presentation at 2020 World Congress on Lung Cancer Singapore Worldwide Virtual Event, January 28-31, 2021. Abstract PS01.07.
15. NICE. National Institute for Health and Care Excellence. Available at: https://www.nice.org.uk/. Accessed March 2022.

Job code: UKI-510-0222-00002
Date of Preparation: March 2022