Telisotuzumab vedotin

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) 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 including 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. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide 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 and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 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 . 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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

艾伯维，作为昔日药王的拥有者，面临专利悬崖压境，举起拳头挥向新战场！自免领域并购提速、神经科学重金押注、ADC赛道连出重拳，艾伯维以一场战略大突围，向市场宣告：断腕求生，只为更凶猛的进攻。   01  深陷泥潭艾伯维近年来深陷多重危机，修美乐（阿达木单抗）作为艾伯维的“现金牛”，曾连续十一年蝉联全球药品销售冠军，累计销售额超2000亿美元。然而，随着其在主流市场的专利保护陆续到期，生物类似药的冲击导致其收入断崖式下滑。2024年修美乐销售额同比骤降37.6%至89.93亿美元，较2023年的144亿美元大幅缩水。表1.艾伯维免疫领域核心产品这一颓势直接拖累艾伯维2024年净利润下跌12.03%。尽管艾伯维通过加速推广Rinvoq（乌帕替尼）和Skyrizi（利生奇珠单抗）等自免新药试图填补缺口（表1），但其市场表现仍难以匹敌修美乐的巅峰水平，还要面临强生、赛诺菲等巨头的激烈竞争。在血液瘤领域，艾伯维依赖的BTK抑制剂Imbruvica（伊布替尼）同样陷入增长困境。作为全球首个上市的BTK抑制剂，伊布替尼曾以先发优势占据市场主导地位，2021年销售额高达111.68亿美元。表2.艾伯维肿瘤领域核心产品然而，随着百济神州的泽布替尼、阿斯利康的阿卡替尼等二代BTK抑制剂通过“头对头”试验证明更优疗效与安全性，伊布替尼市场份额被快速瓜分。2024年，伊布替尼销售额同比下滑6.9%至33.47亿美元。尽管Bcl-2抑制剂Venclexta（维奈克拉）仍保持12.9%的增速，但其作为全球唯一获批产品的优势即将被打破，百济神州、亚盛医药等企业的同类药物已进入临床后期，竞争格局日趋严峻（图1）。 图1.各BTK抑制剂产品上市时间及销售情况更为严峻的是，艾伯维在血液瘤领域长达七年的产品空窗期进一步加剧了危机。继2016年维奈克拉上市后，直至2023年5月才推出第三款血液瘤产品Epkinly（CD3/CD20双抗），但其上市一年半仅实现1.46亿美元收入（表2），且需直面罗氏同类产品Glofitamab的竞争。与此同时，艾伯维在CAR-T疗法领域的布局屡屡受挫，2023年终止与Caribou Biosciences的通用型CAR-T合作，被诺华、强生等对手拉开差距。尽管2024年初以14.4亿美元与Umoja Biopharma合作开发原位生成CAR-T疗法，试图通过技术创新弯道超车，但其错失CAR-T第一波商业化红利的现实已难以逆转。  02  频繁动刀为了走出“泥潭”，艾伯维在肿瘤领域多次挥刀，转而瞄准自免与神经科学等赛道。2023年以来，艾伯维在肿瘤领域接连终止多个外部合作与内部管线，涉及ADC、CAR-T、CD47等多个前沿技术方向。仅ADC领域，艾伯维便终止了包括ABBV-154、ABBV-011和ABBV-647在内的7款候选药物开发，其中ABBV-011虽在I期临床中显示出25%的客观缓解率，但其疗效未达差异化优势，最终被战略性放弃。此外，艾伯维还终止了与Caribou Biosciences的通用CAR-T合作项目，退回Harpoon Therapeutics的BCMA三抗HPN217及天境生物的CD47单抗，反映出其对高风险前沿疗法的谨慎态度。这一系列调整的背后，是艾伯维对肿瘤领域资源投入的重新评估。其肿瘤管线当前聚焦于血液肿瘤领域，依赖BTK抑制剂Imbruvica（伊布替尼）和BCL-2抑制剂Venclexta（维奈克拉）两大成熟产品；而外部合作项目的终止则暴露出其在实体瘤领域协同联用方案的短板，其与加科思合作的SHP2抑制剂因缺乏内部KRAS或PD-1抑制剂等联用搭档而终止，凸显了管线协同性的不足。艾伯维通过“减法”策略，将资源集中于确定性更高的领域，规避早期项目的高失败率与长周期风险。面对修美乐（Humira）专利悬崖的压力，艾伯维加速通过并购与许可合作扩充自免管线（表3）。2022年至2024年，其自免领域交易频繁，包括以17.1亿美元获得明济生物临床前TL1A抗体FG-M701的全球权益，收购Nimble Therapeutics的口服多肽IL-23R抑制剂，以及2.5亿美元收购Celsius Therapeutics的TREM1抗体CEL383。TL1A靶点因其在炎症性肠病（IBD）等领域的广谱治疗潜力成为布局重点，艾伯维试图通过差异化工程化改造建立竞争优势。表3 艾伯维在自免领域license-in交易汇总数据来源：公开资料整理更为关键的是，神经科学领域则成为艾伯维的第二增长引擎。2024年以87亿美元收购Cerevel Therapeutics后，其神经科学管线覆盖精神分裂症、阿尔茨海默病精神病等适应症，尽管核心资产emraclidine的II期临床数据不及预期，但该领域整体收入仍实现16.6%增长，成为业绩重要支撑。此外，艾伯维持续剥离非核心资产，如将囊性纤维化（CF）项目转让给Sionna Therapeutics，进一步聚焦优势赛道。  03  ADC亮剑与此同时，艾伯维聚焦ADC领域，两次“亮剑”。2023年11月，艾伯维以101亿美元收购ADC领域先驱ImmunoGen，核心目标是其重磅产品Elahere（mirvetuximab soravtansine）。Elahere是全球首个靶向叶酸受体α（FRα）的ADC药物，于2022年11月获FDA加速批准用于铂类耐药卵巢癌（PROC）治疗，并于2024年3月获得完全批准。Elahere填补了PROC治疗的空白，其在III期临床试验中显示出显著的总生存期（OS）获益，为FRα阳性患者提供了首个有效治疗方案（图2）。 图2.Elahere 的作用机制（左）及NCT04296890临床数据（右）Elahere的商业表现同样亮眼，2023年前三季度销售额达2.12亿美元，2024年销售额增至4.79亿美元，全年增长潜力强劲。此外，ImmunoGen的研发管线还包括十余项ADC项目（图3），如针对CD123的血液瘤药物IMGN-632及下一代FRα ADC药物IMGN-151，进一步丰富了艾伯维在实体瘤和血液瘤领域的布局。 图3.ImmunoGen管线图5月14日，艾伯维的c-Met靶向ADC药物Telisotuzumab Vedotin（ABBV-399）获FDA加速批准上市（图4），用于治疗c-Met高表达、EGFR野生型晚期非小细胞肺癌（NSCLC）患者。该药物是全球首个获批的c-Met ADC，针对约占NSCLC患者18%的c-Met高表达群体，解决了此类患者缺乏有效靶向治疗的难题。 图4.Telisotuzumab Vedotin（ABBV-399）获FDA批准上市临床数据显示，ABBV-399在II期试验中对高表达患者的客观缓解率（ORR）达34.6%，中位无进展生存期（PFS）为5.7个月，尽管总生存期（OS）提升有限（高表达组14.6个月）（图5），但其差异化定位，避开EGFR突变耐药的内卷市场，专注于野生型患者，为其赢得了独特的市场空间。 图5.ABBV-399的LUMINOSITY 临床II期的数据此外，艾伯维还推进了下一代c-Met ADC药物ABBV-400的研发，该药物采用新型TOP1抑制剂载荷，在结直肠癌和胃癌的早期临床试验中表现出更高缓解率（ORR≥35%），进一步拓展了c-Met靶点的应用场景。目前，c-Met靶点在ADC领域的开发尚处早期，艾伯维凭借先发优势及ABBV-400的多适应症布局，有望在未来进一步确立领导地位。与此同时，全球c-Met ADC领域竞争加剧，罗氏就曾以10.5亿美元引进宜联生物的c-Met ADC项目，但艾伯维凭借成熟的商业化表现与临床推进效率，仍占据显著优势。  结语  从专利悬崖的泥潭中跃起，艾伯维用减法聚焦核心，以加法拓宽边界。尽管前路强敌环伺，但巨头的拳头既已挥出，便注定要重塑战场规则！参考资料[1]https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression[2] https://ascopubs.org/doi/pdfdirect/10.1200/JCO.24.00720[3]艾伯维官网、中信建投证券、各种公开资料等识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。