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是一种用于之前接受治疗的非角鳞性非小细胞肺癌（NSCLC）患者，其c-Met蛋白过度表达的探索性抗体药物结合物（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.
- 生物制品许可申请（BLA）的加速批准提交得到了第2期LUMINOSITY试验（M14-239）数据的支持。BLA的审阅将在FDA肿瘤卓越中心（OCE）实时肿瘤审查（RTOR）计划下进行。
- 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.
- 目前尚无针对c-Met过度表达的NSCLC批准的抗癌疗法，如果获批，Teliso-V将成为该患者群体的首个一类疗法。
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.
伊利诺伊州北芝加哥，2024年9月27日 / PRNewswire / - 艾伯维（纽交所：ABBV）今天宣布向美国食品药品监督管理局（FDA）递交了关于加速批准telisotuzumab vedotin（Teliso-V）用于成人先前接受治疗的EGFR基因突变型的局部晚期或转移性鳞状非小细胞肺癌（NSCLC）并具有c-Met蛋白过度表达的生物制品许可申请（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.
大约85%的肺癌被归类为NSCLC1，尽管治疗取得了进展，但肺癌仍然是全球癌症相关死亡的主要原因。 c-Met蛋白是一种受体酪氨酸激酶，在约25%的晚期EGFR基因突变型、非鳞状NSCLC患者中过度表达，与不良预后有关。 Teliso-V正在在目前治疗选择非常有限的这一患者群体中进行评估。
"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."
“非小细胞肺癌患者存在未满足的医疗需求，肿瘤学家正在寻找这些患者的新治疗选择，这些患者不幸有着不良预后，”艾伯维研发副总裁，首席科学官罗帕尔·萨卡博士说道。 “我们希望Teliso-V将成为特定患者的差异化治疗，我们期待着提升肿瘤治疗标准。”
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授予突破性疗法指定。BLA提交得到来自第2阶段LUMINOSITY试验（研究M14-239）的数据支持，这是一项旨在表征c-Met过度表达NSCLC人群中Teliso-V的安全性和有效性的进行中研究。LUMINOSITY研究的数据最近在2024年美国临床肿瘤学会大会上进行了展示，并该试验的最新数据在2023年分享。Teliso-V正在进一步评估作为单药疗法在先前接受治疗的c-Met过度表达NSCLC患者中的作用，这是随机第3阶段确证全球研究TeliMEt NSCLC-01。该研究正在进行中，并在全球临床试验站点继续。有关Teliso-V临床试验的更多信息，请访问。
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.
关于Telisotuzumab Vedotin（Teliso-V）
Teliso-V是一种调查中的一类，第一类c-Met蛋白定向抗体药物偶联物（ADC），旨在靶向c-Met过表达的肿瘤。c-Met是一种受体酪氨酸激酶，在许多实体肿瘤中（包括NSCLC）可以过度表达。有关Teliso-V临床试验的更多信息，请访问。Teliso-V尚未获得任何卫生监管机构批准。
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).
关于LUMINOSITY试验
LUMINOSITY试验（M14-239）是一项进行中的第2阶段研究，旨在确定最适合Teliso-V单药治疗的NSCLC人群，这些人群在第二线或第三线设置中c-Met过度表达，然后扩展群组以进一步评估所选人群的有效性。终点包括整体应答率（ORR），应答持续时间（DoR），疾病控制率（DCR），独立中央回顾的无进展生存期（PFS）以及总体生存率（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.
在艾伯维，我们致力于为难治性癌症患者改变治疗标准。我们正在推进一系列肿瘤类型的研究性治疗药物，包括血液肿瘤和实体肿瘤。我们致力于创建靶向治疗肿瘤细胞繁殖或使其消除的靶向药物。我们通过各种靶向治疗模式来达成这一目标，包括抗体药物偶联物（ADCs）、免疫肿瘤学以及双特异性和CAR-T平台。我们的专业团队与创新合作伙伴联手加速潜在的突破性治疗药物的推出。
在艾伯维公司，我们致力于改变患有难治性癌症的患者护理标准。我们正在推进一系列涉及血液癌症和实体肿瘤的调查治疗管线。我们专注于创造有针对性的药物，可以阻止癌细胞的繁殖或促使其消除。我们通过各种有针对性的治疗模式包括抗体药物偶联物（ADCs）、免疫肿瘤学、双特异性抗体和CAR-T平台来实现这一目标。我们致力于与创新伙伴携手加速潜在突破性药物的交付。
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，我们广泛的肿瘤学产品组合涵盖了广泛的血液和实体肿瘤的已批准和研究性治疗方案。我们正在评估超过20种研究性药物，在一些世界上最常见和具有破坏性的癌症中进行多项临床试验。在努力对人们的生活产生显著影响的同时，我们致力于探索解决方案，帮助患者获得我们的抗癌药物。欲了解更多信息，请访问 。
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.
关于艾伯维公司
AbbVie的使命是发现和提供创新药物和解决方案，解决当今严重的健康问题并应对未来的医疗挑战。我们致力于在多个关键治疗领域 - 免疫治疗，肿瘤学，神经科学和眼科领域以及Allergan Aesthetics产品和服务方面产生显着影响。有关AbbVie的更多信息，请访问我们的网站。关注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.
前瞻性声明
本新闻公告中的某些声明是前瞻性声明，或可能被视为依据1995年《私人证券诉讼改革法》（Private Securities Litigation Reform Act of 1995）而作出的前瞻性声明。相信，“期望”，“预计”，“预测”和类似表述和使用将来时态或条件语态的动词，通常用来表示前瞻性声明。艾伯维提醒，这些前瞻性声明受到风险和不确定性的影响，这可能会导致实际结果与前瞻性声明中表达或暗示的结果不同。这样的风险和不确定性包括，但不限于，知识产权的挑战，来自其他产品的竞争，研究和开发过程中的困难，不利的诉讼或政府行动，以及适用于我们行业的法律和法规的变化。有关可能影响艾伯维运营的经济，竞争，政府，技术和其他因素的其他信息，请参见艾伯维的2023年10-K年度报告的1A项“风险因素”，该报告已向证券交易委员会提交，并经由其后续的季度报告10-Q进行了更新。除法律规定外，艾伯维无需且特此拒绝公开披露任何对前瞻性声明的修订，这是因为随后发生的事件或发展。
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.
参考文献：
1. 国家癌症研究所。非小细胞肺癌治疗-专业版。2021年12月8日访问。
2. Bray F, Laversanne m, Sung H, Ferlay J, Siegel RL, Soerjomataram I等。全球癌症统计资讯 2022：GLOBOCAN估计全球185个国家中36种癌症的发病率和死亡率。CA：临床肿瘤学杂志。2024年；74（3）：229-63。
3. Ansell PJ, Baijal S, Liede A等。《癌症研究》（CRUK）- 肺癌大会；2022年英国曼彻斯特。城市希望国家医疗中心临床试验样本和现实世界患者队列中c-MET表达过多的非小细胞肺癌（NSCLC）的患病率和特征。
4. Liang H, Wang m。非小细胞肺癌中的MEt癌基因：MEt失调的机制和靶向HGF/c-Met轴的药物。靶向治疗。2020年；13：2491-510。
5. Park S, Choi YL, Sung CO等。非小细胞肺癌患者MEt拷贝数多和MEt过度表达：结果不佳。组织学与病理学。2012年；27（2）：197-207。
6. Guo b, Cen H, Tan X等。通过发表文献的荟萃分析评估患有非小细胞肺癌并接受手术切除的患者中MEt基因拷贝数和蛋白表达的预后价值。PLOS ONE。2014年；9（6）：e99399。
SOURCE AbbVie
资料来源：艾伯维公司