Amgen Worldwide
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
オンラインリソース
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
疾患教育
重点領域
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
アムジェン株式会社（本社：東京、代表取締役社長：ニール・マグレガー、以下「当社」）はこのたび、デルタ様リガンド3（DLL3）を標的とするBiTE ®（二重特異性T細胞誘導）分子製剤であるタルラタマブ（一般名、開発コード：AMG 757、以下「タルラタマブ」）について、進行・再発の進展型小細胞肺癌（SCLC）を予定の効能又は効果として、日本国内で製造販売承認申請を行いました。
肺がんは世界で2番目に診断数の多いがんであり、世界および日本におけるがんの部位別死亡原因の第一位です1,2。SCLCは肺がん全体の約15％を占め、世界で毎年33万人超が新規にSCLCと診断されていると推計されています1,3-5。SCLCは最も悪性度が高く深刻な固形がんの一つであり、増殖速度が非常に早く、早期に転移しやすい特徴を有しています5。SCLCの長期予後は不良であり、全てのステージにおける5年相対生存率は10％未満であると報告されています6。
進展型SCLCに対する現行の一次治療の奏効率は60～70％と比較的高く、初期反応は良好であるものの、ほとんどの患者さんで治療耐性が生じ、通常は治療後1年以内に再発を認めます7-11。過去20年間、再発SCLCに対し新たに承認された薬剤は存在せず、治療選択肢は限られています。現在利用可能な治療法では、再発SCLCの予後は依然として不良であり、緊急性の高いアンメット・メディカル・ニーズが存在しています。
タルラタマブの日本における製造販売承認申請は、プラチナ製剤を含む化学療法後に進行が認められた進行・再発の進展型SCLC患者を対象として、タルラタマブの有効性、安全性、忍容性および薬物動態（PK）を評価する、第II相、国際共同、多施設共同、非盲検試験（DeLLphi-301試験）から得られた結果に基づき行いました。DeLLphi-301試験のデータは、2023年10月に開催された欧州臨床腫瘍学会（ESMO）において、Late-Breaking Oral Presentationとして発表され、同時にNew England Journal of Medicine誌に掲載されています12,13。
当社は、本年3月1日より、人道的見地から未承認薬等を提供する制度に基づき、SCLCに対するタルラタマブの拡大治験（人道的見地から実施される治験）を実施しています14。
なお、タルラタマブは、2024年2月9日付で厚生労働省より希少疾病用医薬品の指定を受けています。また、2023年12月に米国食品医薬品局（FDA）はタルラタマブの生物学的製剤承認申請（BLA）を受理し、優先審査（Priority Review）に指定しました。アムジェンは可能な限り早くタルラタマブをSCLCの患者さんに提供するべく、世界各国の規制当局と協働してまいります。
タルラタマブについて
タルラタマブはアムジェンの研究者によって開発された新規の半減期延長型BiTE®（二重特異性T細胞誘導）免疫腫瘍療法であり、T細胞上のCD3とSCLC細胞上のDLL3の両方に結合することで、患者さん自身のT細胞をSCLC細胞の近くに誘導します。これにより、免疫シナプスが形成され、がん細胞が溶解されます15,16。約85％～96％の患者さんはSCLC細胞の表面にDLL3を発現しており、正常細胞での発現はごくわずかであることから、DLL3はSCLC患者さんにとって有望な治療標的です8,13,17,18。
タルラタマブの臨床試験について
アムジェンの堅固なタルラタマブ開発プログラムには、単剤療法およびSCLCのより早期のステージにおける併用療法レジメンの一部としてタルラタマブを評価するDeLLphi臨床試験、並びに神経内分泌前立腺がんを対象としてタルラタマブを評価するDeLLpro臨床試験が含まれています。
第Ⅰ相DeLLphi-300試験では、複数の前治療歴を有するSCLC患者さんの23.4％で持続的な有効性が認められました。第Ⅱ相DeLLphi-301試験では、2ライン以上の前治療が無効であった進行SCLC患者さんにタルラタマブ10 mgを2週間ごとに投与したときの客観的奏効率は40％でした。DeLLphi-300試験およびDeLLphi-301試験のいずれにおいても、治験薬と関連のある主な有害事象はサイトカイン放出症候群（CRS：52～55％）、発熱（31～37％）および味覚異常（22～26％）であり、これらは主にグレード1～2でした。有害事象による投与中止は上記二試験で患者さんの3～4％に認められました8,13。
タルラタマブの臨床試験の詳細については、www.tarlatamabclinicaltrials.com をご参照ください。
BiTE ®テクノロジーについて
BiTE
®テクノロジーは、患者さん自身のT細胞をいずれかの腫瘍特異抗原に誘導し、T細胞の細胞傷害能を活性化することでがん細胞を排除するように設計された、免疫腫瘍療法のプラットフォームです。BiTEプラットフォームは、腫瘍特異抗原を介して様々な種類のがん腫を治療できる可能性があります。BiTEプラットフォームは、全ての医療従事者が必要な時に革新的なT細胞療法を利用できるように開発を進めています。アムジェンは、幅広い種類の血液がんおよび固形がんを対象に複数のBiTE分子を開発しており、患者さんの治療の可能性を広げるために、BiTEテクノロジーのさらなる研究に取り組んでいます。
BiTEテクノロジーの詳細については、https://www.amgenoncology.com/bite-platform.html をご参照ください。
アムジェン株式会社について
アムジェン株式会社は、世界最大規模の独立バイオテクノロジー企業である米国アムジェン社の日本法人です。アムジェン株式会社では、循環器疾患、がん、骨疾患、炎症・免疫性疾患、神経疾患、希少疾患を始めとするアンメット・メディカル・ニーズが高い領域に焦点を絞り、「To
serve patients – 患者さんのために、今できるすべてを」というミッションのもと、臨床開発から販売までの活動を行っています。詳細については www.amgen.co.jp をご覧になるか、https://www.facebook.com/amgenjapan をフォローしてください。
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 Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), 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 on our business, outcomes, progress, 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.
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. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems 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. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. 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 favorable to us, or at all.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
注意事項（アムジェン株式会社）
このニュースリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的とするものではありません。
###
この件に関するお問い合わせ先
アムジェン株式会社（東京）
コーポレート・アフェアーズ
TEL 080-4950-6230
References