AbbVie (NYSE: ABBV) today announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study.

AbbVie（纽约证券交易所：ABBV）今天宣布，第一名患者在CERVINO 3期研究中接受了研究性ABBV-383治疗。（笑声）。

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..

ABBV-383是一种独特的B细胞成熟抗原（BCMA）和CD3双特异性抗体T细胞参与者，由二价BCMA结合结构域组成，允许高BCMA亲和力和低亲和力CD3结合结构域。ABBV-383正在进行一项3期，多中心，随机，开放标签研究，与接受至少两行先前治疗的r/r MM患者的标准可用疗法进行比较。。

'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.

“尽管治疗取得了显着进展，但大多数多发性骨髓瘤患者最终会复发。晚期疾病患者，尤其是在社区环境中，通常无法获得新的治疗方案，而现有方案的治疗负担很高，包括频繁给药。

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.'.

PeterVoorhees，临床医学教授，心房健康莱文癌症研究所浆细胞疾病主任。“CERVINO 3期试验旨在评估每月给药的ABBV-383的疗效，我们期待着看到数据的出现。”。

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.

多发性骨髓瘤是一种以浆细胞异常增殖为特征的血癌，可引起终末器官损伤，是世界上第二大最常见的血癌。2 2020年，全球估计有176000人被诊断出患有多发性骨髓瘤，117000人死于该病。

'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.

“CERVINO 3期试验的开始标志着AbbVie继续致力于推进新的肿瘤学治疗，提高血癌患者的护理标准，迈出了重要的一步，”医学博士、AbbVie血液学肿瘤学治疗领域负责人副总裁MarianaCota Stirner说。

'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.'.

“如果在临床试验中得到证实，则从治疗开始每月对ABBV-383进行评估，目标是最大限度地简化医生和患者的治疗。”。

About the CERVINO Study

关于CERVINO研究

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.

CERVINO（NCT06158841）是一项全球性的，3期，多中心，随机，开放标签，平行组研究，评估ABBV-383在成年患者（≥18岁）中的r/r MM和东部肿瘤协作组表现状态≤2谁接受了至少两个以前的治疗线，包括暴露于PI，IMiD和抗CD38单克隆抗体。

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..

接受过BCMA靶向治疗的患者将被排除在外。患者将以1:1的比例随机接受静脉注射ABBV-383 60mg Q4W或研究者选择的SAT（卡非佐米+地塞米松，elotuzumab+pomalidomide+地塞米松，或selinexor+硼替佐米+地塞米松），并将继续治疗，直到符合确诊的进行性疾病或其他停药标准。。

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..

双重主要终点是无进展生存期和总体缓解率。次要终点包括总生存率，完全缓解（CR）或更好，非常好的部分缓解或更好，最小残留疾病阴性率，以及疾病症状和身体机能的变化。。

Approximately 140 sites globally will enroll approximately 380 total patients.

全球约140个站点将招募约380名患者。

Additional information about the study can be found at https://clinicaltrials.gov/ under the identifier NCT06158841.

有关该研究的其他信息，请访问https://clinicaltrials.gov/在标识符NCT06158841下。

About ABBV-383

关于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.

ABBV-383是一种研究性独特的BCMA x CD3双特异性抗体T细胞参与者，由二价高亲和力BCMA结合结构域，设计用于减少细胞因子释放的低亲和力CD3结合结构域和设计用于延长半衰期的沉默Fc尾部组成，可支持每4周一次（Q4W）给药。

Clinical relevance of these structure activity relationships has not been established..

这些结构-活性关系的临床相关性尚未确定。。

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

BCMA在多发性骨髓瘤的恶性浆细胞表面高度表达，使其成为治疗的理想靶点。BCMA通过促进骨髓瘤细胞的生长和抑制其凋亡（程序性细胞死亡）在骨髓瘤细胞的存活中起着至关重要的作用

About AbbVie in Oncology

关于肿瘤学中的AbbVie

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.

在艾伯维，我们致力于改变难以治疗的癌症患者的护理标准。我们正在推进一系列血癌和实体瘤癌症类型的动态研究疗法。我们正在专注于开发靶向药物，这些药物要么阻碍癌细胞的繁殖，要么能够消除癌细胞。

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..

我们通过各种靶向治疗方式实现这一目标，包括抗体-药物偶联物（ADC），免疫肿瘤学以及双特异性和CAR-T平台。我们专注且经验丰富的团队与创新合作伙伴携手合作，加速潜在突破性药物的交付。。

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.

今天，我们广泛的肿瘤学组合包括针对各种血液和实体瘤的批准和研究性治疗。我们正在评估世界上一些最广泛和最致命的癌症中的20多种研究药物。在我们努力对人们的生活产生重大影响的同时，我们致力于探索解决方案，帮助患者获得我们的癌症药物。

For more information, please visit us at http://www.abbvie.com/oncology..

有关更多信息，请访问我们http://www.abbvie.com/oncology..

About AbbVie

关于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.

AbbVie的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在几个关键治疗领域——免疫学、肿瘤学、神经科学和眼部护理——以及Allergan美学产品组合中的产品和服务，对人们的生活产生重大影响。