Iovance Biotherapeutics Submits Marketing Authorization Application to European Medicines Agency for Lifileucel in Advanced Melanoma
Iovance Biotherapeutics Submits Marketing Authorization Application to European Medicines Agency for Lifileucel in Advanced Melanoma
First of Multiple Planned Global Submissions for Lifileucel in 2024 and 2025
Lifileucel計劃在全球範圍內提交的多份申請中的第一份 在 2024 年和 2025 年
Key Step in Global Expansion to Address >20,000 Patients Annually with Previously Treated Advanced Melanoma
全球擴張的關鍵一步 到 每年治療超過 20,000 名先前接受過治療的晚期黑色素瘤患者
SAN CARLOS, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union (EU) member states.
加利福尼亞州聖卡洛斯,2024年6月28日(GLOBE NEWSWIRE)——專注於爲癌症患者創新、開發和提供新型多克隆腫瘤浸潤淋巴細胞(TIL)細胞療法的商業生物技術公司Iovance Biotherapeutics, Inc.(納斯達克股票代碼:IOVA)向歐洲藥品管理局(EMA)提交了TIL lifileucel的上市許可申請(MAA)細胞療法,用於治療以前接受過PD-1阻斷抗體治療的不可切除或轉移性黑色素瘤的成年患者,如果BRAF V600突變呈陽性,一種有或沒有 MEK 抑制劑的 BRAF 抑制劑。如果獲得批准,lifileucel將成爲所有歐盟(EU)成員國在該治療環境中第一個也是唯一獲批的療法。
Raj K. Puri, M.D., Ph.D., Executive Vice President, Regulatory Strategy and Translational Medicine, stated, "This EU regulatory submission is the first step toward expanding lifileucel into global markets with a high prevalence of advanced melanoma. The unmet need and strength of the clinical data will support approval of lifileucel as the first and only approved therapy for advanced melanoma patients in the EU who have progressed following standard of care therapies. Following the accelerated approval in the U.S., our global expansion strategy can more than double the number of patients with significant unmet need who may access lifileucel."
監管戰略和轉化醫學執行副總裁拉吉·普里醫學博士、博士表示:“這份歐盟監管文件是朝着將lifileucel擴展到晚期黑色素瘤患病率高的全球市場邁出的第一步。未得到滿足的需求和臨床數據的強度將支持批准lifileucel作爲歐盟第一種也是唯一獲得批准的治療方法,這些療法適用於在遵循標準護理療法方面取得進展的晚期黑色素瘤患者。在美國加速批准之後,我們的全球擴張戰略可以使需求嚴重未得到滿足但可能獲得lifileucel的患者人數增加一倍以上。”
The MAA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. If the MAA for lifileucel is validated, which is anticipated in the third quarter of 2024, the Committee for Medicinal Products for Human Use (CHMP) is expected to issue a scientific opinion for the European Commission to adopt in 2025. Additional marketing submissions for lifileucel are on track in Canada and the United Kingdom during the second half of 2024 and in Australia in 2025. Each year, more than 20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia.1
lifileucel的MAA申請得到了臨床陽性的支持 數據 來自針對晚期抗PD1黑色素瘤患者的 C-144-01 臨床試驗。如果lifileucel的MAA獲得驗證(預計將在2024年第三季度進行),則人用藥品委員會(CHMP)預計將在2025年發佈科學意見供歐盟委員會通過。2024年下半年,加拿大和英國以及2025年在澳大利亞提交的lifileucel的更多營銷申請已步入正軌。在美國、歐盟、英國、加拿大和澳大利亞,每年有超過20,000人死於晚期黑色素瘤。1
1.World Health Organization International Agency for Research on Cancer (IARC) GLOBOCAN 2022.
1。世界衛生組織國際癌症研究機構(IARC)GLOBOCAN 2022年。
About Iovance Biotherapeutics, Inc.
關於 Iovance Biotherapeutics, Inc
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Iovance 生物療法, Inc. 的目標是成爲爲癌症患者創新、開發和提供腫瘤浸潤淋巴細胞 (TIL) 療法的全球領導者。我們正在開創一種變革性的癌症治療方法,利用人體免疫系統識別和摧毀每位患者體內不同的癌細胞的能力。Iovance TIL平台已經展示了針對多種實體瘤的令人鼓舞的臨床數據。Iovance的Amtagvi是美國食品藥品管理局批准的第一種用於實體瘤適應症的T細胞療法。我們致力於細胞療法的持續創新,包括基因編輯的細胞療法,這可能會延長和改善癌症患者的壽命。欲了解更多信息,請訪問 www.iovance.com。
Amtagvi and its accompanying design marks, Proleukin, Iovance, and IovanceCares are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Amtagvi 及其附帶的設計標誌 Proleukin,Iovance,iovanceCares 是 Iovance Biotherapeutics, Inc. 或其子公司的商標和註冊商標。所有其他商標和註冊商標均爲其各自所有者的財產。
Forward-Looking Statements
前瞻性陳述
Certain matters discussed in this press release are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we," "us," or "our") within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Without limiting the foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "forecast," "guidance," "outlook," "may," "can," "could," "might," "will," "should," or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ("FDA") approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ("EMA") approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the effects of the COVID-19 pandemic; and other factors, including general economic conditions and regulatory developments, not within our control.
本新聞稿中討論的某些事項是1995年《私人證券訴訟改革法》(“PSLRA”)所指的Iovance Biotherapeutics, Inc.(以下簡稱 “公司”、“我們” 或 “我們的”)的 “前瞻性陳述”。在不限制前述內容的情況下,在某些情況下,我們可能會使用諸如 “預測”、“相信”、“潛在”、“繼續”、“估計”、“預期”、“計劃”、“打算”、“預測”、“指導”、“展望”、“可能”、“可能”、“可能”、“將”、“應該” 等詞語或其他詞語未來事件或結果的不確定性,旨在識別前瞻性陳述。前瞻性陳述基於管理層的經驗和對歷史趨勢、當前狀況、預期未來發展以及其他被認爲合適的因素的看法所做的假設和評估。本新聞稿中的前瞻性陳述自本新聞稿發佈之日起作出,我們沒有義務更新或修改任何此類陳述,無論是由於新信息、未來事件還是其他原因。前瞻性陳述不能保證未來的表現,並受風險、不確定性和其他因素的影響,其中許多因素是我們無法控制的,這些因素可能導致實際結果、活動水平、業績、成就和發展與這些前瞻性陳述所表達或暗示的結果存在重大差異。我們向美國證券交易委員會提交的文件中標題爲 “風險因素” 的章節描述了可能導致實際業績、發展和商業決策與前瞻性陳述存在重大差異的重要因素,包括我們最新的10-K表年度報告和10-Q表季度報告,包括但不限於我們業務固有的以下已知和未知的重大風險和不確定性:與我們成功商業化能力相關的風險產品,包括我們已獲得美國食品藥品監督管理局(“FDA”)批准的Amtagvi和Proleukin,我們已獲得美國食品藥品監督管理局和歐洲藥品管理局(“EMA”)的批准;EMA或其他前美國監管機構可能不批准或推遲批准我們提交的轉移性黑色素瘤lifileucel上市許可申請的風險;市場對我們產品的接受,包括Amtagvi和 Proleukin及其潛在定價和/或付款人報銷,如果獲得批准(對於我們的候選產品而言)美國和其他國際市場,以及這種接受程度是否足以支持我們的產品(分別包括Amtagvi和Proleukin或候選產品)的持續商業化或開發;未來的競爭或其他市場因素可能會對Amtagvi或Proleukin的商業潛力產生不利影響;我們有能力或無法使用第三方製造商或在我們自己的工廠生產療法的風險,包括我們提高此類第三方製造商的製造能力的能力;以及我們自己的設施,可能會對我們的商業發佈產生不利影響;我們贊助的試驗可能無法反映在我們贊助的試驗中;成功整合最近收購的Proleukin的風險;成功開發或商業化我們的產品(包括Amtagvi和Proleukin)可能無法從產品銷售中產生足夠收入的風險,我們可能在短期內或根本無法盈利;相關風險根據時機以及我們的成功能力制定、提交、獲得或維持 FDA、EMA 或其他監管機構對我們的候選產品的批准或其他行動;無論臨床試驗的結果是否來自我們的關鍵研究和群組,以及與 FDA、EMA 或其他監管機構的會議,都可能支持註冊研究和後續獲得 FDA、EMA 或其他監管機構的批准,包括計劃中的單臂 2 期 IOV-LUN-202 試驗可能不支持註冊的風險;初步和中期臨床結果,其中可能包括療效和來自正在進行的臨床試驗或隊列的安全性結果可能不會反映在我們正在進行的臨床試驗或這些試驗中的亞組的最終分析中,也可能無法反映在先前的其他試驗或隊列中;根據美國食品藥品管理局和其他監管機構的意見,可能需要根據我們的試驗和這些試驗中的隊列調整入組的風險;宮頸癌患者護理格局的變化可能影響我們在該適應症中的臨床試驗的風險;我們可能面臨的風險需要進行額外的臨床試驗或修改正在進行或將來的臨床試驗基於FDA、EMA或其他監管機構反饋的臨床試驗;我們對臨床試驗結果的解釋或與FDA、EMA或其他監管機構的溝通可能與此類監管機構對此類結果或溝通(包括我們先前與美國食品藥品管理局就我們的非小細胞肺癌臨床試驗舉行的會議)的解釋有所不同的風險;來自Amtagvi正在進行的臨床試驗的臨床數據不會持續或重複的風險或計劃中的臨床試行或可能不支持監管機構的批准或續期;意外支出可能減少我們估計的現金餘額和預測並增加我們的預計資本需求的風險;COVID-19 疫情的影響;以及其他不在我們控制範圍內的因素,包括總體經濟狀況和監管發展。
CONTACTS Iovance Biotherapeutics, Inc: Sara Pellegrino, IRC Senior Vice President, Investor Relations & Corporate Communications 650-260-7120 ext. 264 Sara.Pellegrino@iovance.com Jen Saunders Senior Director, Investor Relations & Corporate Communications 267-485-3119 Jen.Saunders@iovance.com
聯繫人 Iovance Biotherapeutics, Inc.:薩拉·佩萊格里諾,IRC 投資者關係和企業傳播高級副總裁 650-260-7120 分機 264 Sara.Pellegrino@iovance.com Jen Saunders 投資者關係與企業傳播高級董事 267-485-3119 Jen.Saunders@iovance.com
Source: Iovance Biotherapeutics, Inc.
來源:Iovance Biotherapeutics, Inc.