AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer
AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer
- Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
- Teliso-V是一種用於之前接受治療的非角鱗性非小細胞肺癌（NSCLC）患者，其c-Met蛋白過度表達的探索性抗體藥物結合物（ADC）。
- Biologics License Application (BLA) submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial (M14-239). Review of the BLA will be conducted under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.
- 生物製品許可申請（BLA）的加速批准提交得到了第2期LUMINOSITY試驗（M14-239）數據的支持。BLA的審閱將在FDA腫瘤卓越中心（OCE）實時腫瘤審查（RTOR）計劃下進行。
- There are currently no approved anti-cancer therapies specifically for c-Met overexpressing NSCLC and if approved Teliso-V would be the first-in-class therapy for this patient population.
- 目前尚無針對c-Met過度表達的NSCLC批准的抗癌療法，如果獲批，Teliso-V將成爲該患者群體的首個一類療法。
NORTH CHICAGO, Ill., Sept. 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
伊利諾伊州北芝加哥，2024年9月27日 / PRNewswire / - 艾伯維（紐交所：ABBV）今天宣佈向美國食品藥品監督管理局（FDA）遞交了關於加速批准telisotuzumab vedotin（Teliso-V）用於成人先前接受治療的EGFR基因突變型的局部晚期或轉移性鱗狀非小細胞肺癌（NSCLC）並具有c-Met蛋白過度表達的生物製品許可申請（BLA）。
Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world.2 The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients3 and is associated with a poor prognosis.4,5,6 Teliso-V is being evaluated within this patient population who currently have very limited treatment options.
大約85%的肺癌被歸類爲NSCLC1，儘管治療取得了進展，但肺癌仍然是全球癌症相關死亡的主要原因。 c-Met蛋白是一種受體酪氨酸激酶，在約25%的晚期EGFR基因突變型、非鱗狀NSCLC患者中過度表達，與不良預後有關。 Teliso-V正在在目前治療選擇非常有限的這一患者群體中進行評估。
"Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology."
「非小細胞肺癌患者存在未滿足的醫療需求，腫瘤學家正在尋找這些患者的新治療選擇，這些患者不幸有着不良預後，」艾伯維研發副總裁，首席科學官羅帕爾·薩卡博士說道。 「我們希望Teliso-V將成爲特定患者的差異化治療，我們期待着提升腫瘤治療標準。」
In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA. The BLA submission is supported by data from Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations. Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress and topline data from this trial were shared in 2023. Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites. Additional information on clinical trials for Teliso-V is available at .
2021年12月，Teliso-V被FDA授予突破性療法指定。BLA提交得到來自第2階段LUMINOSITY試驗（研究M14-239）的數據支持，這是一項旨在表徵c-Met過度表達NSCLC人群中Teliso-V的安全性和有效性的進行中研究。LUMINOSITY研究的數據最近在2024年美國臨床腫瘤學會大會上進行了展示，並該試驗的最新數據在2023年分享。Teliso-V正在進一步評估作爲單藥療法在先前接受治療的c-Met過度表達NSCLC患者中的作用，這是隨機第3階段確證全球研究TeliMEt NSCLC-01。該研究正在進行中，並在全球臨床試驗站點繼續。有關Teliso-V臨床試驗的更多信息，請訪問。
About Telisotuzumab Vedotin (Teliso-V)
Teliso-V is an investigational, first-in-class, c-Met protein directed antibody-drug conjugate (ADC) designed to target c-Met overexpressing tumors. c-Met is a receptor tyrosine kinase that can be overexpressed in many solid tumors including NSCLC. Further information on clinical trials for Teliso-V is available at . Teliso-V is not approved by any health regulatory authority.
關於Telisotuzumab Vedotin（Teliso-V）
Teliso-V是一種調查中的一類，第一類c-Met蛋白定向抗體藥物偶聯物（ADC），旨在靶向c-Met過表達的腫瘤。c-Met是一種受體酪氨酸激酶，在許多實體腫瘤中（包括NSCLC）可以過度表達。有關Teliso-V臨床試驗的更多信息，請訪問。Teliso-V尚未獲得任何衛生監管機構批准。
About the LUMINOSITY Trial
The LUMINOSITY trial (M14-239), is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS).
關於LUMINOSITY試驗
LUMINOSITY試驗（M14-239）是一項進行中的第2階段研究，旨在確定最適合Teliso-V單藥治療的NSCLC人群，這些人群在第二線或第三線設置中c-Met過度表達，然後擴展群組以進一步評估所選人群的有效性。終點包括整體應答率（ORR），應答持續時間（DoR），疾病控制率（DCR），獨立中央回顧的無進展生存期（PFS）以及總體生存率（OS）。
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities including antibody-drug conjugates (ADCs), immuno-oncology, bi-specific antibody and CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
在艾伯維，我們致力於爲難治性癌症患者改變治療標準。我們正在推進一系列腫瘤類型的研究性治療藥物，包括血液腫瘤和實體腫瘤。我們致力於創建靶向治療腫瘤細胞繁殖或使其消除的靶向藥物。我們通過各種靶向治療模式來達成這一目標，包括抗體藥物偶聯物（ADCs）、免疫腫瘤學以及雙特異性和CAR-T平台。我們的專業團隊與創新合作伙伴聯手加速潛在的突破性治療藥物的推出。
在艾伯維公司，我們致力於改變患有難治性癌症的患者護理標準。我們正在推進一系列涉及血液癌症和實體腫瘤的調查治療管線。我們專注於創造有針對性的藥物，可以阻止癌細胞的繁殖或促使其消除。我們通過各種有針對性的治療模式包括抗體藥物偶聯物（ADCs）、免疫腫瘤學、雙特異性抗體和CAR-T平台來實現這一目標。我們致力於與創新夥伴攜手加速潛在突破性藥物的交付。
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit .
今天，我們廣泛的腫瘤學產品組合涵蓋了廣泛的血液和實體腫瘤的已批准和研究性治療方案。我們正在評估超過20種研究性藥物，在一些世界上最常見和具有破壞性的癌症中進行多項臨床試驗。在努力對人們的生活產生顯著影響的同時，我們致力於探索解決方案，幫助患者獲得我們的抗癌藥物。欲了解更多信息，請訪問 。
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
關於艾伯維公司
AbbVie的使命是發現和提供創新藥物和解決方案，解決當今嚴重的健康問題並應對未來的醫療挑戰。我們致力於在多個關鍵治療領域 - 免疫治療，腫瘤學，神經科學和眼科領域以及Allergan Aesthetics產品和服務方面產生顯着影響。有關AbbVie的更多信息，請訪問我們的網站。關注LinkedIn，Facebook，Instagram，X (formerly Twitter)和YouTube上的@abbvie。
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
前瞻性聲明
本新聞公告中的某些聲明是前瞻性聲明，或可能被視爲依據1995年《私人證券訴訟改革法》（Private Securities Litigation Reform Act of 1995）而作出的前瞻性聲明。相信，「期望」，「預計」，「預測」和類似表述和使用將來時態或條件語態的動詞，通常用來表示前瞻性聲明。艾伯維提醒，這些前瞻性聲明受到風險和不確定性的影響，這可能會導致實際結果與前瞻性聲明中表達或暗示的結果不同。這樣的風險和不確定性包括，但不限於，知識產權的挑戰，來自其他產品的競爭，研究和開發過程中的困難，不利的訴訟或政府行動，以及適用於我們行業的法律和法規的變化。有關可能影響艾伯維運營的經濟，競爭，政府，技術和其他因素的其他信息，請參見艾伯維的2023年10-K年度報告的1A項「風險因素」，該報告已向證券交易委員會提交，並經由其後續的季度報告10-Q進行了更新。除法律規定外，艾伯維無需且特此拒絕公開披露任何對前瞻性聲明的修訂，這是因爲隨後發生的事件或發展。
References:
1 National Cancer Institute. Non-small cell lung cancer treatment – health professional version. Accessed December 8, 2021.
2 Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2024;74(3):229-63.
3 Ansell PJ, Baijal S, Liede A, et al. Prevalence and Characterization of c-MET–Overexpressing Non-small Cell Lung Cancer (NSCLC) Across Clinical Trial Samples and Real-world Patient Cohorts From the City of Hope National Medical Center. Cancer Research UK (CRUK) - Lung Cancer Conference; Manchester, UK2022.
4 Liang H, Wang M. MET Oncogene in Non-Small Cell Lung Cancer: Mechanism of MET Dysregulation and Agents Targeting the HGF/c-Met Axis. Onco Targets Ther. 2020;13:2491-510.
5 Park S, Choi YL, Sung CO, et al. High MET copy number and MET overexpression: poor outcome in non-small cell lung cancer patients. Histol Histopathol. 2012;27(2):197-207.
6 Guo B, Cen H, Tan X, et al. Prognostic value of MET gene copy number and protein expression in patients with surgically resected non-small cell lung cancer: a meta-analysis of published literatures. PLoS One. 2014;9(6):e99399.
參考文獻：
1. 國家癌症研究所。非小細胞肺癌治療-專業版。2021年12月8日訪問。
2. Bray F, Laversanne m, Sung H, Ferlay J, Siegel RL, Soerjomataram I等。全球癌症統計資訊 2022：GLOBOCAN估計全球185個國家中36種癌症的發病率和死亡率。CA：臨床腫瘤學雜誌。2024年；74（3）：229-63。
3. Ansell PJ, Baijal S, Liede A等。《癌症研究》（CRUK）- 肺癌大會；2022年英國曼徹斯特。城市希望國家醫療中心臨床試驗樣本和現實世界患者隊列中c-MET表達過多的非小細胞肺癌（NSCLC）的患病率和特徵。
4. Liang H, Wang m。非小細胞肺癌中的MEt癌基因：MEt失調的機制和靶向HGF/c-Met軸的藥物。靶向治療。2020年；13：2491-510。
5. Park S, Choi YL, Sung CO等。非小細胞肺癌患者MEt拷貝數多和MEt過度表達：結果不佳。組織學與病理學。2012年；27（2）：197-207。
6. Guo b, Cen H, Tan X等。通過發表文獻的薈萃分析評估患有非小細胞肺癌並接受手術切除的患者中MEt基因拷貝數和蛋白表達的預後價值。PLOS ONE。2014年；9（6）：e99399。
SOURCE AbbVie
資料來源：艾伯維公司