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 and pharmacokinetics of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world
In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week 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 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2024-06-01

申办/合作机构

AbbVie, Inc.

NCT06158841 / Recruiting临床3期

A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

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 change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. . In Arm A, participants will receive ABBV-383 as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.
In Arm A participants will receive ABBV-383 as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year 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 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2024-05-01

申办/合作机构

AbbVie, Inc.

NCT06158854 / Recruiting临床1/2期

An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis

Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383.
ABBV-383 is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses. After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 20 sites across the world.
Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year 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 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2024-04-01

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 相关的专利（医药）

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项与 Etentamig 相关的文献（医药）

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 ; Polepally, Akshanth R. ; Jin, Ziyi ; Shah, Nina ; Buelow, Ben ; Pothacamury, Rajvineeth K. ; Ross, Jeremy A.

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.

2020-07-01·EJHaem

Ex vivo efficacy of BCMA‐bispecific antibody TNB‐383B in relapsed/refractory multiple myeloma

Article

作者: Leonidas, Marina ; Ndiaye, Ami ; Voorhees, Peter M. ; Rigby, Katherine ; Foureau, David M. ; Atrash, Shebli ; Buelow, Ben ; Symanowski, James T. ; Guo, Fei ; Paul, Barry A. ; Tjaden, Elise ; Bhutani, Manisha ; Robinson, Myra ; Pham, Duy ; Steuerwald, Nury ; Usmani, Saad Z.

Abstract:

TNB‐383B is a fully human BCMA‐targeting T‐cell engaging bispecific monoclonal antibody (T‐BsAb). We assessed ex vivo efficacy of this drug to mediate killing of bone marrow mononuclear cells (BMMCs) freshly isolated from 10 patients with relapsed multiple myeloma (MM). BMMC were treated ex vivo with TNB‐383B at doses ranging from 0.001‐1 μg. Plasma cell (PC) lysis, viability, BCMA expression, CTL distribution, and degranulation were assessed by flow cytometry. Cytokine response to TNB‐383B was quantified by multiplex protein assay. Dose‐dependent PC lysis was triggered in all cases by TNB‐383B at doses as low as 0.001 μg (P = .0102). Primary MM cells varied in BCMA expression. High BCMA+ PC count correlated with increased PC lysis (P = .005) and significant CTL degranulation specific to TNB‐383B treatment (P = .0153 at 1 μg). High E:T ratio in bone marrow specimens led to lower viable and higher apoptotic PC compared with low E:T ratio (P < .001). Three cytokines were significantly modulated by TNB‐383B: IL‐2/TNFα increased by ∼4 ± 3.5‐fold average (P < .005 at 1 μg) and IP10 increased by ∼50 ± 15‐fold (P < .001 at 1 μg). We conclude that TNB‐383B triggers primary PC lysis and CTL degranulation in a dose‐dependent fashion ex vivo with no T cell expansion and mild increase of CRS‐associated cytokines.

项与 Etentamig 相关的新闻（医药）

2024-06-05

·PRNewswire

AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.1 ABBV-383 is being evaluated in a Phase 3, multicenter, randomized, open-label study compared with standard available therapies in patients with r/r MM who received at least two lines of prior therapy. "Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse. Patients with advanced disease, especially in the community setting, often have limited access to novel treatment options and existing options have a high treatment burden, including frequent dosing," said Dr. Peter Voorhees, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute. "The CERVINO Phase 3 trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges." Multiple myeloma is a blood cancer characterized by abnormal proliferation of plasma cells, which can cause end-organ damage and is the second most commonly occurring blood cancer in the world.2 An estimated 176,000 people globally were diagnosed with multiple myeloma in 2020, and 117,000 people died from the disease.3 "The start of the CERVINO Phase 3 trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients," said Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie. "ABBV-383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximizing treatment simplicity for physicians and patients, if proven in the clinical trials." About the CERVINO Study CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label, parallel-group study evaluating ABBV-383 in adult patients (≥18 years) with r/r MM and an Eastern Cooperative Oncology Group performance status ≤2 who received at least two prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb. Patients who received prior BCMA-targeted therapy will be excluded. Patients will be randomized 1:1 to receive intravenous ABBV-383 60mg Q4W or the investigator's choice of SAT (carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone), and will continue treatment until confirmed progressive disease or other discontinuation criteria are met. The dual primary end points are progression-free survival and overall response rate. Secondary end points include overall survival, complete response (CR) or better, very good partial response or better, rate of minimum residual disease negativity, and change in disease symptoms and physical functioning. Approximately 140 sites globally will enroll approximately 380 total patients. Additional information about the study can be found at under the identifier NCT06158841. About ABBV-383 ABBV-383 is an investigational distinctive BCMA x CD3 bispecific antibody T-cell engager composed of bivalent high-avidity BCMA-binding domains, a low-affinity CD3-binding domain designed to reduce cytokine release, and a silenced Fc tail designed for an extended half-life that may support once every 4-week (Q4W) dosing. Clinical relevance of these structure activity relationships has not been established. BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it an ideal target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).4 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, and bi-specific and 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 is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines 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 us at . 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. 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. 1 Foureau DM, Bhutani M, Robinson M, et al: Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma. EJHaem 1:113-121, 2020 2 International Myeloma Foundation. What is Multiple Myeloma? 3 Cancer.Net. Multiple Myeloma: Statistics. . 4 Cho SF, Anderson KC, Tai YT: Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol 9:1821, 2018 SOURCE AbbVie

临床3期免疫疗法ASCO会议

2024-06-05

·BioPharmaDive

Lilly details MASH data for tirzepatide; Cytokinetics comments on past sale talks

Today, a brief rundown of news from Eli Lilly, Cytokinetics and AbbVie, as well as updates from Gilead and the National Institutes of Health that you may have missed from earlier this week.Eli Lillys drug tirzepatide sold as Zepbound for obesity continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the studys success earlier this year, but the full data will provide a more complete view of tirzepatides potential. The abstracts release comes one day after Viking Therapeutics released trial datafor its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug. Madrigal shares fell Wednesday morning, as did those of several other MASH drug developers. Jonathan GardnerCytokinetics CEO Robert Blum confirmed the biotechnology company held sale talks late last year, as was reported around then by The Wall Street Journal and Reuters. In comments at a conference hosted by the investment bank Jefferies Wednesday, he said Cytokinetics engaged in good faith negotiations with an unnamed third party regarding an acquisition. While Cytokinetics board was supportive of proceeding with discussions on substantially the terms the counterparty communicated, that company ultimately did not move forward with an acquisition. Ned PagliaruloGilead Sciences has reached an agreement to settle federal lawsuits alleging the company delayed introducing an antiviral treatment so that it could extend patent protection for its HIV drug business. The company, which has not admitted liability or wrongdoing, will pay up to $40 million to a group of approximately 2,625 plaintiffs, provided 98% agree to the settlement. Litigation in California on this same issue, which involves two forms of the HIV drug tenofovir, remains pending at the states supreme court. Ned PagliaruloAbbVie said Wednesday it has enrolled the first patient in a Phase 3 trial of its dual-acting antibody ABBV-383 for multiple myeloma. ABBV-383 binds to a protein flag called BCMA on diseased cells and another called CD3 on T cells to spur an immune attack on the blood cancer. The mechanism is similar to that of the approved drugs from Johnson & Johnson and Pfizer. AbbVies trial will enroll 380 people whose disease has progressed after at least two lines of therapy. Patients will receive either ABBV-383 or another combination therapy. Researchers will follow patients to assess treatment responses and whether AbbVies drug helps stave off cancer progression better than the comparator treatments. Jonathan GardnerTwo clinical trials will test Gilead Sciences long-acting HIV drug lencapavir as preventive therapy in cisgender women and in people who inject drugs. The studies, which are funded by Gilead and run through the HIV Prevention Trials Network, will test whether twice-yearly injections of lencapavir works better as pre-exposure prophylaxis than an existing regimen. Cisgender women and injectable drug users have been underrepresented in studies of HIV treatment, according to a statement from the National Institutes of Health, which provides grants to the trials network. Ned Pagliarulo '

临床3期并购临床研究上市批准

2024-03-16

·医药魔方

双抗药物竞争格局：市场规模超80亿美元，罗氏领跑，实体瘤产品将成主力

2023年是ADC赛道如火如荼的一年，也是双抗赛道风生水起的一年。去年，全球新增4款双抗药物获批上市，越来越多布局双抗的药企开始进入收获期。与此同时，双抗药物市场规模也来到了新的高度，12款药物的全年销售额达到了83亿美元。已上市双抗药物2023年销售额（单位：亿美元）注：*收入为安进所计全球收入+安斯泰来所计日本收入总和2023年，罗氏仍然是双抗赛道的“领头羊”，两款“重磅炸弹”药物均由其孕育而出。艾美赛珠单抗（Hemlibra）仍然是目前唯一一款在血友病领域应用的双抗药物，也是助力罗氏打下双抗“江山”的关键武器。自上市以来，该产品销售额持续快速增长，2023年已爬升至46.35亿美元，为双抗市场规模贡献超一半。不过，艾美赛珠单抗的竞争对手已经出现——诺和诺德的NNC0365-3769今年有望完成III期研究并申报上市。罗氏已有应对之策，正在开发新一代双抗NXT007，其与FIX和FX形成三元复合物的能力显著优于艾美赛珠单抗。罗氏推出的另一款重磅产品——法瑞西单抗也为双抗药物市场规模增长提供了强大的推动力，一年之间销售额实现了3倍增长（26.34 vs. 6.19亿美元）。如今，罗氏正在全力探索法瑞西单抗在其它眼科疾病上的治疗潜力，未来其市场空间将进一步扩大。法瑞西单抗作为一款VEGF-A/Ang2双抗，凭借双重作用机制以及较长的半衰期赢得了临床及市场的认可，也吸引了其它玩家进入眼科双抗赛道。据医药魔方Nextpharma数据库统计，目前全球共9款临床在研眼科双抗药物（不包括已上市的法瑞西单抗），其中6款均为VEGF/Ang2双抗。临床在研眼科双抗药物2023年也是血液瘤领域迎来更加多样化的治疗选择的一年，新增的4款上市双抗产品均为血液瘤用药。在血液瘤领域，数CD3/BCMA双抗赛道竞争最为激烈，从已上市产品和后期在研药物数量即可窥见这一点。根据医药魔方Nextpharma数据库统计，目前全球共17款进入III期阶段或申请上市阶段的双抗药物（不包括双抗ADC），其中3款为CD3/BCMA双抗，分别为linvoseltamab（再生元）、TNB-383B（艾伯维）和alnuctamab（BMS）。目前，已上市双抗药物的应用方向以血液系统恶性肿瘤为主，相关产品占比高达58%（7/12）。不过，这种趋势在近两年将出现变化，在处于后期开发阶段的双抗药物中，针对实体瘤的双抗产品已成为“大多数”。后期在研双抗药物注：红色为血液瘤产品在ADC概念盛行的当下，由双抗药物衍生的双抗ADC产品亦是药企较为关注的方向。目前，全球范围内进入后期开发阶段的双抗ADC仅JSKN-003（康宁杰瑞）和BL-B01D1（百利天恒/BMS），其余产品仍处于早期阶段。这两款产品所针对的疾病有所不同，JSKN-003主要面向乳腺癌，而BL-B01D1的应用范围更广。在极度“内卷”且市场份额正在被德曲妥珠单抗吞并的HER2赛道，JSKN-003作为进度遥遥领先的一款HER2双抗ADC，可谓是其中为数不多具有差异化优势的产品。康宁杰瑞曾在2022年年报中提到，JSKN-003的对手是德曲妥珠单抗，已有多项临床前研究结果证明二者具有可比性，并且JSKN-003可以覆盖HER2高中低表达人群。JSKN-003的另一个优势在于创新偶联技术带来的更高的血清稳定性。总的来说，JSKN-003未来所面临的市场竞争还是比较激烈的，既要与德曲妥珠单抗交战，又要与HER2双抗产品厮杀。BL-B01D1是百利天恒开发的一款HER3/EGFR双抗ADC，其小分子毒素部分为百利天恒自主研发的喜树碱衍生物ED04，DAR值为8。BL-B01D1的优势在于，其抗体部分（SI-B001）并不会直接与HER3相结合，从而避免了分子对于维持正常生理功能靶点的抑制作用，药物的毒副作用低。该产品虽是目前唯一一款HER3/EGFR双抗ADC，在同赛道尚无竞争压力。但是，来自于HER3和EGFR各自赛道的新一代在研药物也将是其不容小觑的竞争对手，例如HER3单抗ADC和四代EGFR抑制剂。在HER3赛道，全球共19款临床在研产品（包括多靶点产品），其中进度最为领先也是最为热议的莫过于第一三共的HER3单抗ADC HER3-DXd（见：全球首个！第一三共/默沙东HER3 ADC在美申报上市）。在EGFR赛道，EGFR ADC和四代EGFR抑制剂的临床进展是目前的焦点话题。EGFR ADC赛道的产品基本处于早期阶段，进度最快的MRG003（III期阶段）尚无NSCLC数据公布，未来这类产品的情况值得关注；四代EGFR抑制剂赛道，已有3款产品披露过临床数据。BBT-176（Bridge Biotherapeutics）和BLU-945（Blueprint Medicines）的数据一言难尽，但BDTX-1535倒是表现不错，ORR达到了50%（6/12）。双抗赛道和ADC赛道的发展趋势，既有所同，也有所不同。相同之处在于，这两个赛道均存在领跑企业，不同之处在于ADC赛道中的国内药企正在崛起，而双抗赛道还未形成国内药企加速进场的局面。推荐阅读制药巨头2024年展望：值得期待的里程碑事件2023年全球制药巨头自免业务排名TOP10ADC药物市场规模突破100亿美元！第一三共、罗氏、辉瑞领跑，中国药企加速进场2023年全球仿制药巨头TOP10星条旗下的宝藏：美国生物类似药市场2023概览Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线下沙龙↑ 长按扫码，报名沙龙 ↑审核通过将收到手机短信通知

抗体药物偶联物临床3期上市批准临床2期申请上市

100 项与 Etentamig 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
多发性骨髓瘤	临床3期	以色列	AbbVie, Inc.	2024-05-01
多发性骨髓瘤	临床3期	葡萄牙	AbbVie, Inc.	2024-05-01
多发性骨髓瘤	临床3期	韩国	AbbVie, Inc.	2024-05-01
多发性骨髓瘤	临床3期	西班牙	AbbVie, Inc.	2024-05-01
多发性骨髓瘤	临床3期	瑞典	AbbVie, Inc.	2024-05-01
多发性骨髓瘤	临床3期	中国台湾	AbbVie, Inc.	2024-05-01
免疫球蛋白轻链淀粉样变性	临床2期	美国	AbbVie, Inc.	2024-04-01
免疫球蛋白轻链淀粉样变性	临床2期	日本	AbbVie, Inc.	2024-04-01
免疫球蛋白轻链淀粉样变性	临床2期	澳大利亚	AbbVie, Inc.	2024-04-01
浆细胞骨髓瘤难治	临床2期	美国	TeneoOne, Inc.	2019-06-24

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临床结果

适应症

分期

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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 (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	膚夢夢簾製鏇獵餘製壓(製選廠夢願構蓋窪膚襯) = 89% reduction of CD8+ T cells from periphery 遞鹽製艱蓋膚廠鏇製糧 (襯膚膚淵獵窪觸範壓艱 ) 更多	积极	2024-05-24
				ABBV-383 40 mg Q3W
NCT03933735 (NCT03933735, ASCO2024)	临床1期	复发性多发性骨髓瘤	220	ABBV-383 60mg Q4W	襯憲範簾鑰窪築鏇糧願(淵淵淵壓糧願鬱網鬱繭) = 鑰選艱蓋製糧築製遞鏇糧窪構鹽願窪顧願廠構 (醖獵選鏇願鹽糧築淵夢 ) 更多	积极	2024-05-24
				ABBV-383 40mg Q3W	襯憲範簾鑰窪築鏇糧願(淵淵淵壓糧願鬱網鬱繭) = 壓網餘廠夢鏇範壓衊鏇糧窪構鹽願窪顧願廠構 (醖獵選鏇願鹽糧築淵夢 ) 更多
NCT03933735 (NCT06158841, ASCO2024)	临床1期	复发性多发性骨髓瘤 BCMA- \| CD3	220	ABBV-383 20 mg Q3W	選選糧餘鑰鑰築艱鹹構(夢齋獵繭繭網壓遞淵獵) = 築鹽簾鹹鏇網簾壓廠選窪範遞獵襯廠製壓鹹壓 (網餘鹽糧鏇鏇範獵齋餘 ) 更多	积极	2024-05-24
				ABBV-383 40 mg Q3W	選選糧餘鑰鑰築艱鹹構(夢齋獵繭繭網壓遞淵獵) = 鬱製襯憲鹹觸糧憲醖襯窪範遞獵襯廠製壓鹹壓 (網餘鹽糧鏇鏇範獵齋餘 ) 更多
NCT03933735 (phase 1 trial, EHA2024)	临床1期	复发性多发性骨髓瘤 BCMA \| CD3	220	ABBV-383 60mg Q4W	膚製遞積選構醖蓋範鹹(構廠簾夢選繭壓遞憲簾) = 淵蓋餘糧鏇獵遞網簾淵範選鬱製積夢構觸膚醖 (繭夢選積窪鹽憲鹹膚齋 ) 更多	积极	2024-05-14
				ABBV-383 40mg Q3W	膚製遞積選構醖蓋範鹹(構廠簾夢選繭壓遞憲簾) = 範築蓋糧積窪夢繭醖鹹範選鬱製積夢構觸膚醖 (繭夢選積窪鹽憲鹹膚齋 ) 更多
IMS2023	临床1期	复发性多发性骨髓瘤 BCMA-positive \| CD3	-	ABBV-383	壓簾築顧齋獵醖憲壓願(艱窪築獵壓範壓獵繭淵) = anemia (29%) 淵製廠齋鹽糧膚築築製 (夢襯範廠繭選網夢鬱齋 ) 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)	鑰積窪網壓衊積構繭襯(範構簾鬱齋顧鹹繭蓋醖) = 觸廠淵選顧積觸構淵膚遞餘鏇夢醖網構夢鏇廠 (築鹽壓製鏇醖鏇窪鬱衊 ) 更多	积极	2022-08-27
				ABBV-383 (EXP)	鑰積窪網壓衊積構繭襯(範構簾鬱齋顧鹹繭蓋醖) = 衊簾憲壓鑰憲窪範蓋衊遞餘鏇夢醖網構夢鏇廠 (築鹽壓製鏇醖鏇窪鬱衊 ) 更多
NCT03933735 (IMS2022)	临床1期	复发性多发性骨髓瘤	124	ABBV-383	淵構鹹構範齋築簾艱廠(糧構窪鏇願蓋網觸製憲) = Among pts treated at 60mg (n=60; ESC+EXP), CRS occurred in 72% of the pts (48% G1; 22% G2; 2% G3) with the first dose, with median time to onset and resolution of 1 day (0% recurrence). Other AEs observed in >20% of all pts are fatigue (30%; G3-4, 1%), anemia (29%; G3-4, 16%), nausea (29%; G3-4, 2%), diarrhea (27%; G3-4, 2%), vomiting (24%; G3-4, 0%), and neutrophil count decreased (22%; G3-4, 19%) 醖憲製窪願壓網壓鏇襯 (糧願範夢範製廠顧衊夢 ) 更多	-	2022-08-25