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AMGEN KRAS G12C INHIBITOR LUMYKRAS™▼ (SOTORASIB) RECEIVES CONDITIONAL MARKETING AUTHORISATION* BY MHRA FOR USE IN GREAT BRITAIN

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 Immunotherapy1,5

Sotorasib Becomes The First New Cancer Medicine To Receive Conditional Marketing Authorisation In Great Britain Under The Project Orbis Review Framework; Phase 2 Clinical Trial Results Demonstrated 37.1% Of Patients Responded To Treatment With 80.6% Achieving Disease Control2


CAMBRIDGE, UK -- (10 September 2021) -- Amgen UK today announces that its first-in-class medicine sotorasib (a targeted KRAS G12C inhibitor formerly named AMG 510) has become the first new cancer therapy to receive Conditional Marketing Authorisation for use1 across England, Scotland and Wales by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis. This authorisation follows a review of sotorasib’s role in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C gene mutation.

KRAS is one of the most frequently mutated genes in human cancers.3 KRAS G12C is one of the most common identified or known driver mutations in NSCLC.4,9 Sotorasib, which is administered orally as a tablet formulation5, binds with a mutated KRAS G12C protein to ‘switch off’ the signals it sends to trigger cell division and cancer cell growth.3 Sotorasib has been shown to irreversibly bind to the inactive KRAS G12C protein, permanently locking it in an inactive state, leading to inhibition of cancer cell growth.3, 6-8

Project Orbis is an international collaborative programme between the U.S. Food and Drug Administration (FDA) and regulatory agencies worldwide. It is designed to deliver efficient and effective review of new oncology products and their potential benefit to patients and health systems. Project Orbis helps support earlier access to innovative new medicines, like sotorasib.

Professor Sanjay Popat, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Lung cancer driven by the KRAS G12C mutation is a highly aggressive cancer when it has relapsed after standard treatments and sotorasib is a first-in-class medicine, allowing eligible patients to receive daily tablets rather than chemotherapy in the hospital. I’m therefore delighted to see this rapid MHRA Conditional Marketing Authorisation. Importantly, in parallel the NHS is making excellent progress in the 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, Amgen UK and Ireland, said: “Today’s Conditional Marketing Authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options. This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.”5

 “Sotorasib is the first targeted KRAS G12C inhibitor to be authorised for use in Great Britain. Targeting KRAS has been a 40-year quest by scientists and researchers around the World. Approximately 13% of patients with NSCLC harbour the KRAS G12C mutation3, 10 and whilst approximately 48,000 people are diagnosed with lung cancer every year in the UK12,13 it is estimated that 5,000 of these people will have KRAS G12C-mutated NSCLC.”

The MHRA review of sotorasib centred around the Phase 2 CodeBreaK 100 clinical study which evaluated sotorasib in 126 patients with KRAS G12C-mutated advanced NSCLC. Patients were treated with sotorasib 960 mg once daily orally, and prior to the trial, patients had progressed on platinum-based chemotherapy and/or PD1/PD-LI immunotherapy.2

Data presented earlier this year during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (held 28th – 31st January 2021), demonstrated for the major efficacy outcome measures, a confirmed objective response rate (ORR) of 37.1% (95% CI: 28.6, 46.2), and a disease control rate (DCR) of 80.6% (95% CI: 72.6, 87.2). Additional outcome measures included a median progression-free survival of 6.8 months (95% CI: 5.1, 8.2) (data cut-off of December 1, 2020).11

Recently published data in the New England Journal of Medicine show a median overall survival (OS) of 12.5 months (95% CI, 10.0 to could not be evaluated) among 124 evaluable patients, (data cut-off of March 15, 2021).2 The median duration of response (DoR), which was evaluated in 46 patients was shown to be 11.1 months (95% CI, 6.9 to could not be evaluated). (OS and DoR were secondary outcome measures).2

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

NSCLC accounts for 80-85% of all lung cancers, and most patients (66%) are diagnosed with advanced or metastatic disease.12, 13 KRAS G12C is one of the most common identified or known driver mutations in NSCLC.4 There is a high unmet need for patients with advanced  NSCLC receiving second or subsequent lines of therapy.2

Cancer Research UK estimates there are around 48,000 new lung cancer cases in the UK every year, making it the country’s third most common form of cancer.13 While rates of detected lung cancer have dropped considerably in the last 30 years, it remains a condition with a high mortality rate, accounting for 21% of all cancer deaths in the UK (data from 2018).12  People in the UK diagnosed with lung cancer have a one-year survival rate of 41% (data from 2013-2017) and a 5-year survival rate of 16% (data from 2013-2017).12 Only 9.5% of people diagnosed with lung cancer are predicted to survive their disease for 10 years of more.1

*Additional efficacy and safety data are being collected


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. 6 Sotorasib was the first KRAS G12C inhibitor to enter the clinic and is being studied in 10 combinations with global sites spanning four continents.14 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.15

Further information about sotorasib can be found in the Summary of Product Characteristics sent with this news release.

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.16,17

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicentre study, enrolled patients with KRAS G12C-mutant solid tumours.16 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.16 The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST 1.1 at baseline.2, 11

A global Phase 3 randomised active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) includes sites across the UK.17

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

Job code: UKI-510-0621-00005
Date of Preparation: September 2021

###

Contact

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

Name: Con Franklin (Ketchum)
Telephone: +44 (0) 7974 434151
Email: con.franklin@ketchum.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  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.

References

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