Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide
Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

开始日期2025-11-12

申办/合作机构

AbbVie, Inc.

NCT06896916

/ Recruiting临床1期

Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.
In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

开始日期2025-08-31

申办/合作机构

TeneoOne, Inc.

NCT06892522

/ Recruiting临床1/2期

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

开始日期2025-06-30

申办/合作机构

AbbVie, Inc.

100 项与 Etentamig 相关的临床结果

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100 项与 Etentamig 相关的转化医学

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100 项与 Etentamig 相关的专利（医药）

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项与 Etentamig 相关的文献（医药）

2025-05-01·Clinical Lymphoma Myeloma & Leukemia

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives

Review

作者: Rasche, Leo ; Einsele, Hermann ; Waldschmidt, Johannes M ; Kortüm, K Martin

Despite significant advancements, multiple myeloma (MM) remains incurable, and there is still a pressing need for new therapeutic strategies with highly selective mechanisms of action and balanced off-target toxicity. In recent years, the development of "off-the-shelf" bispecific antibodies (bsAbs) has significantly enhanced our ability to treat relapsed or refractory MM. Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Meanwhile, the range of available bsAbs is rapidly expanding, offering patients and healthcare providers a broad selection of options that vary in target antigens, binding domains, construct designs, dosing regimens, and side effects. As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and implications for efficacy and safety, with the aim of achieving deeper responses and longer overall survival for MM patients.

2022-11-02·Cancer discovery

ABBV-383 Demonstrates Tolerability and Efficacy in Relapsed/Refractory MM

Article

Abstract:

The T cell–engaging bispecific antibody ABBV-383 was well tolerated in relapsed/refractory multiple myeloma (RRMM).

2022-11-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma

Article

作者: Kumar, Shaji ; Lee, Shane ; Bueno, Orlando F. ; Yue, Susan ; Rodriguez, Cesar ; Voorhees, Peter M. ; Vij, Ravi ; Freise, Kevin J. ; D'Souza, Anita ; Talati, Chetasi ; Weisel, Katja ; Jin, Ziyi ; Polepally, Akshanth R. ; Shah, Nina ; Buelow, Ben ; Ross, Jeremy A. ; Pothacamury, Rajvineeth K.

PURPOSE:

ABBV-383, a B-cell maturation antigen × CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier: NCT03933735 ) in patients with relapsed/refractory multiple myeloma (RRMM). Herein, we report safety and efficacy outcomes of this phase I dose escalation/expansion study.

METHODS:

Patients with RRMM (≥ three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody) were eligible. ABBV-383 was administered intravenously over 1-2 hours once every 3 weeks, without any step dosing. A 3 + 3 design with backfilling for dose escalation was used (intrapatient escalation to highest safe dose permitted) followed by initiation of dose expansion.

RESULTS:

As of January 8, 2022, 124 patients (dose escalation [0.025-120 mg], n = 73; dose expansion [60 mg], n = 51) have received ABBV-383; median age was 68 years (range, 35-92 years). The most common hematologic treatment-emergent adverse events (TEAEs) were neutropenia (all grades: 37%) and anemia (29%). The most common nonhematologic TEAEs were cytokine release syndrome (57%) and fatigue (30%). Seven deaths from TEAEs were reported with all considered unrelated to study drug by the investigator. For all efficacy-evaluable patients (n = 122; all doses), the objective response rate (ORR) was 57% and very good partial response (VGPR) or better (≥ VGPR) rate was 43%. In the 60 mg dose expansion cohort (n = 49), the ORR and ≥ VGPR rates were 59% and 39%, respectively; and in the ≥ 40 mg dose escalation plus dose expansion cohorts (n = 79) were 68% and 54%, respectively.

CONCLUSION:

ABBV-383 in patients with RRMM was well tolerated with an ORR of 68% at doses ≥ 40 mg. This novel therapy's promising preliminary antitumor activity in heavily pretreated patients warrants further clinical evaluation.

项与 Etentamig 相关的新闻（医药）

2025-07-14

·生物制药小编

TCE + In vivo CAR-T：艾伯维在下一盘大棋

近一年多来，艾伯维频频出手，通过引进或并购的方式扩充自己的TCE及In vivo CAR-T管线及平台。我们可以怀疑艾伯维的研发能力，但我们要相信其战略眼光。读懂艾伯维的研发策略能帮助国内企业更好的布局相关产品及技术。艾伯维的修美乐（TNFα抑制剂）曾经霸榜全球药王11年，但终究由于专利到期而走下了神坛。为了填补专利悬崖带来的销售空白，艾伯维提前十多年布局，通过自研+引进的方式成功的开发出乌帕替尼（JAK1抑制剂）及利生奇珠单抗（IL-23抑制剂），2024年销售分别达59.7及117.2亿美元。肿瘤板块是艾伯维四大业务板块之一，而血液瘤产品则占据了其近年来的主要收入。但艾伯维的两款重磅血液瘤产品，伊布替尼（Imbruvica；BTK抑制剂）和维奈克拉（Venclexta；Bcl-2抑制剂），均面临着专利悬崖及竞争产品的双重压力。为了破局，艾伯维在血液瘤领域也采取了自研+引进的方式。自研方面，艾伯维开发了下一代BTK降解剂（ABBV-101）、Bcl-2抑制剂（ABBV-453）、MALT1抑制剂（ABBV-525）及CD19-ADC（ABBV-319），但目前均处于临床1期。而在引进方面，艾伯维做了广泛的布局。特别是从最近一年的引进及并购交易来看，艾伯维在血液瘤的布局侧重于TCE及In vivo CAR-T。1、TCE其实，艾伯维早在二十年前就开发了自己的双抗平台DVD-Ig，并在十年多前开始尝试研发自己的CD3 TCE，但至今未有自研产品进入临床。2020年6月，艾伯维以7.5亿美元预付款+31.5亿美元里程碑付款的巨额交易，获得Genmab研发的Epcoritamab（CD3/CD20双抗）的全球权益（美国和日本市场由双方共同商业化）（图1）。图1. Epcoritamab结构示意图当时，Epcoritamab处于临床1/2期，而罗氏及再生元的CD3/CD20双抗已进入临床2期。后来，Mosunetzumab、Epcoritamab、Glofitamab分别于2022年12月、2023年5月、2023年6月获FDA批准上市，2024年三款药物的销售分别为0.78、2.81、1.9亿美元。尽管Epcoritamab后来居上，在销售上领先于罗氏的两款CD3/CD20双抗，但距离成为重磅药物还有相当距离。2017年10月，艾伯维与Harpoon Therapeutics达成合作协议，前者利用后者的TriTAC平台开发选定靶向药。2019年11月，艾伯维与Harpoon再次签订独家许可协议扩大合作，前者获得当时处于临床1期的CD3/BCMA/HSA三抗（HPN217）的全球开发权（图2）。图2. HPN217结构示意图2021年6月，艾伯维以1.4亿美元的价格收购了TeneoOne（TeneoBio子公司），获得一款处于临床1期的CD3/BCMA双抗（TNB-383B），TNB-383B双抗采用2+1设计，细胞因子释放效应最小化（图3）。图3. TNB-383B结构示意图2023年10月，艾伯维终止了HPN217的进一步开发而专注于TNB-383B（ABBV-383）的开发。2024年6月，艾伯维启动了ABBV-383的临床3期试验。但是，目前全球已有两款CD3/BCMA双抗上市，分别是强生的Teclistamab及辉瑞的Elranatamab，分别于2022年10月及2023年8月获FDA批准上市。而BMS的CD3/BCMA双抗（Alnuctamab）于2024年1月进入临床3期，但仅几个月后就宣布由于公司策略改变而终止了继续开发（详见双抗 vs CAR-T：BMS的取舍）。因此，对于艾伯维来说，ABBV-383实属鸡肋，获批上市至少还需要2-3年时间，而竞争对手强生的CD3/BCMA双抗的下一代产品CD3/BCMA/GPRC5D三抗（JNJ-79635322）已在临床1期取得了不错的疗效（RP2D ORR 100%；预期1年PFS 95%）。这就是艾伯维于今年1月以10.55亿美元的价格由先声再明引进CD3/BCMA/GPRC5D三抗（SIM0500）的重要原因（图4）。图4. SIM0500结构示意图然而，研究MM患者样本显示，GPRC5D的表达存在显著差异，CD38、CD138、BCMA和GPRC5D的中位数和标准差分别为89和113、69和134、58和132、10和166。因此，CD3/BCMA/GPRC5D三抗针对BCMA/GPRC5D均低表达的患者是否有效、药效能否持久存在不确定性。这就能解释为什么艾伯维在引进CD3/BCMA/GPRC5D三抗半年后又以首付7亿美元、总额19.25亿美元从IGI Therapeutics引进了CD3/BCMA/CD38三抗（ISB2001）（图5）。图5. ISB2001结构示意图强生的达雷妥尤（CD38）单抗是MM领域目前的药王，2024年销售达116.7亿美元。而ISB2001主要针对达雷妥尤单抗耐药的患者进行设计，其CD38臂与达雷妥尤单抗的抗原结合域有着显著区别并且对CD38弱表达的细胞仍有杀伤功能，而CD38表达降低是达雷妥尤单抗耐药的重要机制之一。ISB2001目前处于临床1期剂量爬坡最后阶段，据今年ASCO大会上公开信息显示，ISB2001在极难治RRMM患者中展现出高缓解率（ORR 74%）、深度反应（包括MRD阴性75%）及良好安全性（图6）。图6. ISB2001治疗末线或CD38耐药MM患者预测艾伯维可能同时开发SIM0500及ISB2001，并通过找到临床Biomarker（如GPRC5D）用来区分两款药物不同的适用患者，甚至效仿强生的Teclistamab+Talquetamab（CD3/GPRC5D双抗）联用以及JNJ-79635322+达雷妥尤单抗联用，开发两款三抗的联用。当然从艾伯维过往的行事方式来看，其还有可能通过在临床上比较SIM0500及ISB2001的疗效而二选一。除了直接引进临床阶段TCE产品外，艾伯维还通过与拥有下一代TCE技术的Biotech合作，开发临床前产品。而从其近一年的两起交易来看，艾伯维对包含共刺激信号的TCE很感兴趣。2024年10月，艾伯维与EvolveImmune Therapeutics达成协议，前者以6500万美元的首付款、14亿美元的里程碑付款利用后者的TCE平台开发多款肿瘤药物（详见下一代TCE之共刺激信号的选择：我们从CAR-T学到了什么？）。2025年1月，艾伯维与AbCellera扩大早期达成的合作，共同开发TCE。其中，AbCellera将负责相关发现工作，而艾伯维则拥有发现和商业化由此产生的抗体的权利。通过分析AbCellera相关平台推测，双方合作的焦点可能是AbCellera的CD3/CD28/TAA平台（图7）。图7. AbCellera的CD28平台示意图2、In vivo CAR-T自2017年首次获批以来，自体CAR-T细胞疗法彻底改变了血液瘤的治疗，给对以往疗法失败的患者带来了希望。与此同时，近年来自体CAR-T细胞疗法在自免领域也取得了一系列的突破。然而，目前的自体CAR-T疗法需要采集患者的细胞，并在遥远的生产基地进行数周甚至数月的改造。因此，这些疗法虽然能够显著改善患者的预后，但往往负担过重，未得到广泛的应用。艾伯维作为血液瘤及自免领域的领导者，虽然错过了第一批进入细胞治疗的机会，但希望通过引进项目及技术平台实现弯道超车。2021年2月，艾伯维向Caribou预付了4000万美元，为开发两款新靶点的通用型CAR-T疗法提供3亿美元的研发和注册里程碑付款。艾伯维使用Caribou的下一代Cas12a CRISPR杂合RNA-DNA（chRDNA）基因组编辑和细胞治疗技术，来研究和开发两种针对艾伯维指定靶点的新型CAR-T细胞疗法。Caribou负责临床前研究、开发和制造，艾伯维负责细胞疗法的临床开发、商业化和制造。尽管在2023年，Caribou公布了其通用型CD19 CAR-T疗法CB-010的1期临床试验的积极数据，接受治疗的患者的ORR达94%（15/16），完全缓解（CR）率达69%（11/16），但艾伯维于2023年10月终止了与Caribou的合作。有趣的是，仅仅过了三个月后的2024年1月，艾伯维与Umoja宣布达成合作，利用后者的VivoVec平台（图8）开发针对CD19和其它靶点的In vivo CAR-T疗法，用于治疗恶性血液肿瘤和难治型实体瘤。图8. VivoVec平台示意图2025年6月，艾伯维宣布以21亿美元现金收购成立仅三年、处于临床阶段的生物技术公司Capstan Therapeutics。根据协议，艾伯维此次收购 Capstan，不仅将获得处于临床1期用于治疗B细胞自免疾病的In vivo CD19-CAR-T（CPTX2309）这一极具潜力的在研产品，还将获得Capstan专有的tLNP平台技术（图9）。图9. CPTX2309结构示意图不难看出，通过引进及并购，艾伯维已经获得了In vivo CAR-T的两大主流技术路线，通过慢病毒递送（以Umoja、EsoBiotec为代表）或通过LNP递送（以Capstan为代表），很可能实现弯道超车成为该领域的领导者。结合自研的BTK降解剂（ABBV-101）、CD19-ADC（ABBV-319）等产品，通过TCE及In vivo CAR-T的引进或并购的加持，艾伯维正在B细胞相关疾病领域进行广泛布局并构筑了深深的护城河，而这些药物的单药或联用将继续巩固艾伯维在自免及肿瘤领域的领导地位。

免疫疗法细胞疗法并购抗体药物偶联物临床1期

2025-05-27

·PRNewswire

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- 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

临床结果ASCO会议临床1期抗体药物偶联物临床2期

2025-03-19

·精准药物

Biotech从野蛮生长到理性收缩

作者｜momo 过去十年，Biotech在资本狂欢与技术突破的驱动下，曾以惊人的速度野蛮生长：PD-1单抗扎堆逾百家、TIGIT靶点竞逐、ADC赛道狂热，无数企业涌入同质化赛道，掀起了一场激烈的创新竞赛。然而，当资本退潮、政策趋严、临床试验失败率攀升，Biotech被迫直面“创新效率”的拷问。曾经的“靶点内卷”让位于差异化创新，冗余管线被“精准瘦身”，高风险领域遭遇战略性撤退，标志着行业从“野蛮生长”转向“理性收缩”。 01 中国药企从“烧钱内卷”到“精准狙击” 2024年，国内创新药企掀起一波研发管线终止，折射出行业深层次的结构性挑战。上海医药以近7亿元代价砍掉12项管线，包括因PD-1市场过度竞争而终止的III期宫颈癌药物BCD-100，以及研发进度滞后的类风湿关节炎II期项目I008（图1），这两款药物的累计研发投入分别为5900.80万元和6218.75万元。图1.上海医药终止BCD-100、I008等项目公告数据来源：上海医药官网过去20年间，上海医药累计研发投入超200亿元。高额投入的背后，却是严重不对等的研发成果，上海医药至今只有花费6.9亿元从生诺医药引进的一款抑酸新药信诺拉生酯胶囊（X842）获批上市。 2024年，中国Biotech在资本狂欢褪去后迎来“理性收缩”元年，多家药企掀起研发管线“砍单潮”。天坛生物则因市场情况终止其子公司蓉生药业的“静注巨细胞病毒人免疫球蛋白(ph4)”III期临床试验研究及后续研发。据悉，该公司在这个药物研发上已投入7069.09万元；不谋而合的是，舒泰神也基于新冠市场形势终止了累计研发投入3.83亿元的BDB-001注射液、STSA-1002注射液、STSA-1005注射液等多个项目在COVID-19适应症方向的研究工作。百济神州则战略性终止了与Shoreline Biociences公司的异基因NK细胞疗法合作项目，专注开发自研的细胞治疗产品；类似地，华东医药也放弃疗效逊于HDM1002的口服GLP-1药物TTP273，转向自研潜力产品HDM1002、HDM1005（图2）。图2.华东医药终止TTP273项目公告数据来源：华东医药官网此外，中国Biotech迎来研发寒冬，多家药企因临床试验失败或安全性问题终止核心管线。亚虹医药因APL-1202联合化疗未达主要终点，终止累计投入1.3亿元的核心管线。事实上，亚虹医药已连续多年深陷亏损泥沼，2018年至2023年期间合计净亏损约为15.45亿元；此外，亚宝药业也因II型糖尿病药物SY-004的临床研究未达良好预期而被暂停；宜联生物HER3 ADC（YL202/BNT326）更因临床试验中3例患者死亡遭遇FDA部分叫停，好在已经恢复临床试验。 2024年国内终止项目数量激增，超70%集中在肿瘤及代谢疾病（GLP-1）等同质化赛道，PD-1单抗上市数量远超海外，导致资源严重冗余。中国医药行业正经历从“野蛮生长”到“理性收缩”的阵痛期，企业加速“早期管线止损”，通过聚焦差异化创新重塑竞争力，这场研发寒冬或将成为中国创新药从“量变”到“质变”的分水岭。 02 跨国药企从“广撒网”到“精耕细作” 跨国药企加速研发战略转型，聚焦肿瘤、免疫及神经科学领域高潜力赛道，通过终止或调整临床项目实现资源优化配置，既凸显行业对研发效率的极致追求，亦暴露靶点选择与临床验证的深层风险性。在肿瘤治疗领域，TIGIT靶点研发的集体受挫成为行业焦点。 2023年BMS宣布终止其自研的TIGIT单抗BMS-986207的II期临床试验。同年8月，BMS又退货了Agenus的TIGIT/CD96双抗管线，这意味着其彻底放弃TIGIT靶点；无独有偶，2024年7月，罗氏也终止了TIGIT抗体RG6058的III期临床开发，该产品曾被寄予厚望作为PD-(L)1联合疗法的下一代搭档；图3.罗氏管线调整数据来源：罗氏2024年财报此外，2024年12月，默沙东也因临床数据不足放弃了抗TIGIT抗体vibostolimab的联合疗法开发。这一系列动作使得TIGIT成为继CTLA-4之后又一“折戟沉沙”的免疫检查点靶标，其作用机制和患者筛选标准面临重新审视。与此同时，BMS对肿瘤领域其他靶点药物也展开了大刀阔斧的战略调整。 2024年第二季度，BMS宣布终止CD3/BCMA双抗Alnuctamab的III期开发，尽管该产品在2024年5月刚启动临床试验，但面对再生元Linvoseltamab的上市申请和艾伯维TNB-383B的III期推进，BMS选择战略性退出竞争白热化的BCMA双抗双抗赛道，转而巩固其在CAR-T疗法领域的领先地位。此外，神经退行性疾病领域的高风险性也再次得到验证。罗氏终止了阿尔茨海默病抗Tau单抗bepranemab的开发，这已是该领域近三年内第7个终止的III期项目，凸显β淀粉样蛋白和Tau蛋白假说在临床转化中的困境。阿斯利康则砍掉LOX-1单抗MEDI6570，进一步收缩在脑血管疾病领域的布局。这些调整推动企业将目光转向确定性更高的代谢疾病领域，辉瑞虽因副作用终止GLP-1RA项目洛替列酮，但诺和诺德、礼来在减肥药市场的成功仍吸引着行业持续加码。值得注意的是，在技术平台选择上，ADC和核药成为战略转型的核心方向。吉利德彻底退出CD47赛道，将magrolimab所有研究终止后，转而通过收购扩充肿瘤免疫管线。这种“砍旧立新”的策略在艾伯维身上尤为明显，其在2023年终止了与CytomX Therapeutics关于CX-2029（条件激活CD71 ADC）的合作，并在2024年继续连续终止ABBV-154等3个ADC项目，却在2024年完成对ADC龙头公司的并购，展现“选择性收缩”与“战略性扩张”并行的独特策略。在生物医药创新的新纪元，“少而精”的精准投入正在取代“广撒网”的传统模式，这场静悄悄的革命或将重塑全球制药产业的竞争格局。结语全球Biotech行业正从资本驱动的“野蛮生长”转向科学驱动的“理性收缩”。资本退潮、政策趋严与临床试验失败频发，迫使企业重新审视研发策略，聚焦高潜力赛道与技术平台。这意味着持续深耕差异化创新的企业，终将在行业洗牌中脱颖而出。此外，ADC、双抗、核药等新兴技术平台成为行业转型的核心驱动力，而国际化战略则是企业突破市场瓶颈的必由之路。中国Biotech企业通过出海授权与自建团队加速全球化布局，头部企业如百济神州、信达生物已崭露头角，但中小企业仍需在资金与商业化能力上寻求突破。全球Biotech面对行业分化加剧，短期阵痛不可避免，但长期来看，坚守科学本质与战略定力的企业将赢得未来。无论是跨国巨头还是本土创新者，只有聚焦未被满足的临床需求、开发同类最优药物，才能在“理性收缩”的寒冬中实现从量变到质变的跨越，引领全球Biotech行业迈向新纪元。参考资料 [1]各大企业官网、官微、财报、公告及公开资料声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床3期财报抗体药物偶联物临床2期细胞疗法

100 项与 Etentamig 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
浆细胞白血病	临床3期	美国	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	中国	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	日本	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	澳大利亚	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	奥地利	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	比利时	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	加拿大	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	捷克	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	丹麦	AbbVie, Inc.	2024-05-19
浆细胞白血病	临床3期	法国	AbbVie, Inc.	2024-05-19

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03933735 (Ph 1 studies, ASCO2025)	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	146	Etentamig 60 mg Q4W	鬱範遞顧衊遞範鹽積鹽(築繭膚衊築積齋鹹艱顧) = CRS incidence was 30% (4% G2; No ≥G3 events) with median time to CRS onset of 22.3 (5.5-29.6) hours; and median time to CRS resolution of 20.7 (1.8-131.7) hours 鹽窪鹽鑰積襯襯製鬱網 (範積糧鏇製範鏇膚糧鏇 ) 更多	积极	2025-05-30
EHA2025	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	146	Etentamig 60 mg Q4W	窪窪簾窪壓鹹蓋遞廠淵(糧廠鬱糧觸齋構積艱醖) = 窪製鹽膚鏇觸窪艱網觸醖窪鏇齋淵簾願窪膚餘 (範積壓窪築憲衊簾選範 ) 更多	积极	2025-05-14
NCT03933735 (ASCO2024)	临床1期	复发性多发性骨髓瘤 sBCMA \| IL-6 \| IL-8 ... 更多	-	ABBV-383 20 mg Q3W	夢製齋遞鬱廠鹹廠窪衊(淵鏇膚夢獵艱齋鹹廠鹹) = 89% reduction of CD8+ T cells from periphery 簾齋鬱淵艱積廠築製製 (壓齋遞餘壓糧餘餘簾範 ) 更多	积极	2024-05-24
				ABBV-383 40 mg Q3W
NCT06158841 \| NCT03933735 (ASCO2024)	临床1期	复发性多发性骨髓瘤 BCMA- \| CD3	220	ABBV-383 20 mg Q3W	築憲鑰憲糧壓糧襯鹹繭(獵網衊網鑰蓋築餘網鏇) = 醖壓鏇壓範築築選網淵襯構範廠淵網鏇淵憲餘 (繭衊鹹衊製夢艱製夢構 ) 更多	积极	2024-05-24
				ABBV-383 40 mg Q3W	築憲鑰憲糧壓糧襯鹹繭(獵網衊網鑰蓋築餘網鏇) = 壓遞鬱蓋範鹽餘壓構網襯構範廠淵網鏇淵憲餘 (繭衊鹹衊製夢艱製夢構 ) 更多
NCT03933735 (ASCO2024)	临床1期	复发性多发性骨髓瘤	220	ABBV-383 60mg Q4W	繭構鏇觸繭積膚憲鹽網(鹹繭願鏇簾蓋壓範鏇遞) = 艱憲蓋膚觸窪顧選選築鏇窪鹽壓廠蓋夢夢淵遞 (鏇餘選膚範餘製獵顧顧 ) 更多	积极	2024-05-24
				ABBV-383 40mg Q3W	繭構鏇觸繭積膚憲鹽網(鹹繭願鏇簾蓋壓範鏇遞) = 構鬱鑰願鹹夢窪壓淵廠鏇窪鹽壓廠蓋夢夢淵遞 (鏇餘選膚範餘製獵顧顧 ) 更多
NCT03933735 (phase 1 trial, EHA2024)	临床1期	多发性骨髓瘤 BCMA \| CD3	220	ABBV-383 60mg Q4W	遞艱壓遞築簾餘壓繭製(製廠壓觸製構築顧壓遞) = 範繭願選願窪範廠鏇夢簾鹽蓋齋鏇廠簾衊獵積 (夢夢鹹選壓選憲遞膚簾 ) 更多	积极	2024-05-14
				ABBV-383 40mg Q3W	遞艱壓遞築簾餘壓繭製(製廠壓觸製構築顧壓遞) = 築築構簾齋鑰範廠艱餘簾鹽蓋齋鏇廠簾衊獵積 (夢夢鹹選壓選憲遞膚簾 ) 更多
NCT03933735 (Phase 1 Study, ASH2023)	临床1期	复发性多发性骨髓瘤	220	ABBV-383 20 mg	襯衊願獵壓齋願憲醖憲(製製蓋窪壓夢鬱築築顧) = 獵衊構觸遞願鬱繭餘糧鏇膚鏇網膚襯齋願夢積 (蓋淵糧襯繭繭繭鬱積範 ) 更多	-	2023-12-10
				ABBV-383 40 mg	襯衊願獵壓齋願憲醖憲(製製蓋窪壓夢鬱築築顧) = 蓋憲範醖網顧餘遞齋製鏇膚鏇網膚襯齋願夢積 (蓋淵糧襯繭繭繭鬱積範 ) 更多
ASH2023	N/A	多发性骨髓瘤	1,926	BCMA-directed BsAbs	鏇築範範窪範獵蓋獵鑰(積築襯蓋獵獵膚繭簾積) = 鏇鑰築襯醖衊醖艱選壓製糧壓淵簾糧觸鹹夢觸 (簾餘窪願鬱淵觸範鹹齋 ) 更多	-	2023-12-09
IMS2023	临床1期	复发性多发性骨髓瘤 BCMA-positive \| CD3	-	ABBV-383	築窪範衊獵顧醖願鹽餘(積鹽廠鏇選鹹鹽網廠選) = anemia (29%) 構築鹹醖願獵淵鑰蓋餘 (積窪憲衊襯鑰衊觸製簾 ) 更多	-	2023-09-26
NCT03933735 (Pubmed) 人工标引	临床1期	复发性多发性骨髓瘤末线	128	ABBV-383 (ESC+EXP)	簾築艱製選齋願網構築(憲顧鏇獵餘夢廠醖淵廠) = 範願餘蓋鑰鬱範廠顧築獵獵構網鑰齋艱淵齋糧 (鹹構餘築鹽觸蓋選願蓋 ) 更多	积极	2022-08-27
				ABBV-383 (EXP)	簾築艱製選齋願網構築(憲顧鏇獵餘夢廠醖淵廠) = 艱壓觸範範衊糧簾鹹膚獵獵構網鑰齋艱淵齋糧 (鹹構餘築鹽觸蓋選願蓋 ) 更多