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NICE RECOMMENDS KYPROLIS® (CARFILZOMIB) WITH LENALIDOMIDE AND DEXAMETHASONE (KRd) FOR PREVIOUSLY TREATED MULTIPLE MYELOMA

Final Appraisal Document Recommends KRd For The Treatment Of Multiple Myeloma In Adults After One Previous Therapy Which Included Bortezomib

CAMBRIDGE, UK -- (23 March 2021) – The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Document recommending carfilzomib in combination with lenalidomide and dexamethasone (KRd) for the treatment of multiple myeloma in adults after one previous therapy which included bortezomib1.

The NICE decision to recommend KRd is based on clinical evidence from the Phase 3 ASPIRE trial in patients with relapsed multiple myeloma who had received one to three prior treatments1,2. Amgen has agreed a commercial arrangement with the NHS to make the KRd recommendation available.

Effective combination therapies are required for patients when they relapse or become refractory to their current treatment. For several years, Amgen has worked collaboratively with NICE and other stakeholders, including clinicians and patient advocacy groups, to help overcome the barriers that can prevent access to combination therapies for patients with serious diseases such as multiple myeloma.

Dr. Tony Patrikios, executive medical director at Amgen UK and Ireland said: “The relapsing-remitting nature of multiple myeloma can be psychologically very difficult for patients. Working collaboratively with our partners in the NHS and patient advocacy groups, there has been a strong tenacity to make this treatment combination cost effective and available to patients with multiple myeloma. We welcome this recommendation from NICE which provides another treatment option for patients whose disease has relapsed.”

Multiple myeloma is a complex disease that is characterised by periods of remission and relapse. Approximately 5,700 people in the UK are diagnosed with this incurable disease annually with multiple myeloma accounting for 15% of blood cancers and two per cent of all cancers in the UK3.

Laura Kerby, chief executive of Myeloma UK said: “This approval is great news for the myeloma community, and we are delighted with the decision. Myeloma is an incurable and very individual cancer and this decision means more patients can benefit from the better responses to treatment at an early stage that a triplet regimen can offer. The NICE decision also means that, regardless of where they live in the UK, patients now have equal access to the treatment they need and want. Myeloma UK is committed to ensuring that patients benefit from the latest therapies like triplets, and this is the most recent example of how our approach to partnership working makes that a reality.”

The NICE Final Appraisal Document was published on 19th March but will not become NICE Guidance for the NHS in England and Wales until 28th April 2021.

NOTES TO EDITORS

About carfilzomib

Myeloma cells are particularly susceptible to proteasome inhibition. Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed4. Carfilzomib blocks the function of proteasomes, leading to an excessive build-up of proteins within cells and myeloma cell death5.

Kyprolis® in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy6.

Further information about carfilzomib can be found in the Summary of Product Characteristics available at https://www.medicines.org.uk/emc/product/5061

About the Phase 3 ASPIRE Trial

KRd demonstrated a prolonged median Progression-Free Survival of 26.3 months compared with 17.6 months with lenalidomide and dexamethasone (Rd), with a hazard ratio of 0.66; 95% Confidence Interval (CI), 0.55 to 0.78; P = 0.0001). KRd also increased median overall survival compared with Rd from 40.4 months to 48.3 months (hazard ratio 0.79; 95% CI, 0.67 to 0.95; P = 0.0045) 1,2.

The safety data from ASPIRE was consistent with the known safety profile of carfilzomib. The most common adverse events (greater than or equal to 20 percent) in the carfilzomib arm were diarrhoea, anaemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis7.

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 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, and in 2020 approximately 260,000 UK and Irish patients were treated with Amgen medicines8.

www.amgen.co.uk

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 apremilast acquisition (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 safe 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 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 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

References

  1. NICE. Carfilzomib with dexamethasone and lenalidomide for treating multiple myeloma after at least 1 previous therapy. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta10510/documents [Accessed 22/03/2021].
  2. Stewart K et al NEJM, 2015, 372, 2, 142-152.
  3. Myeloma UK. What is Myeloma? Available at https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/
  4. Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012 Aug 2;120(5):947-59.
  5. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2013 Feb 7;121(6):893-7.
  6. EMC. Kyprolis Powder for Solution for Infusion. Available at https://www.medicines.org.uk/emc/product/5061 [Accessed 22/03/21]
  7. Siegel DS, et al. Improvement in Overall Survival with Carfilzomib, Lenalidomide, and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma. Journal of Clinical Oncology. 2018, Mar 10; Vol. 36, p. 728-737
  8. Amgen data on file.

Job code: UKI-KYP-0321-00001
Date of Preparation: March 2021