/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE

/ -- 艾伯维（AbbVie，NYSE: ABBV）今天公布了二期EPCORE的更新结果

NHL-6 trial ( NCT05451810

NHL-6 试验 (NCT05451810

) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy.

评估在门诊环境中为复发/难治性（R/R）弥漫性大B细胞淋巴瘤（DLBCL）成年患者进行Epcoritamab单药治疗的首次全剂量给药和监测的可行性，这些患者已接受至少一种先前的系统治疗。Epcoritamab是一种通过皮下注射给药的T细胞结合双特异性抗体。

Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. These results were shared today during a poster presentation (Abstract #ABCL-1224) at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting..

研究结果表明，使用Epcoritamab治疗后，细胞因子释放综合征（CRS）和免疫细胞相关神经毒性综合征（ICANS）的发生率和严重程度与之前在复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）中的Epcoritamab研究一致。这些结果在第13届血液肿瘤学会（SOHO）年会上通过海报展示（摘要编号#ABCL-1224）分享。

In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (92%) were monitored in the outpatient setting and seven (8%) in the inpatient setting. Overall, CRS events occurred in 37 (40.2%) of patients during the entire trial period (n=92), were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation.

在研究中，88名患者接受了第一剂完整剂量（48毫克）的epcoritamab单药治疗。其中，81名患者（92%）在门诊接受监测，7名患者（8%）在住院环境下接受监测。总体而言，在整个试验期间（n=92），37名患者（40.2%）发生了CRS事件，主要为低级别（1-2级），所有事件均在中位时间为两天内得到解决，且没有事件导致治疗中断。

ICANS occurred in seven patients (7.6%), were primarily low grade (Grade 1-2), all resolved with a median time of three days, and no events led to treatment discontinuation..

ICANS发生在七名患者（7.6%）中，主要为低级别（1-2级），所有症状均在中位时间为三天内消退，且没有事件导致治疗中断。

'The EPCORE

'EPCORE

NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses,' said

NHL-6试验结果显著，因为目前用于复发或难治性弥漫性大B细胞淋巴瘤患者的双特异性抗体治疗可能需要在某些初始剂量后以及后续剂量后根据需要进行细胞因子释放综合征的住院监测。

, M.D., disease chair, hematology research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene,

医学博士，疾病主席，血液学研究，莎拉·坎农研究所（SCRI）威拉米特山谷癌症研究所，尤金市。

. 'The possibility of treating patients in the outpatient setting is encouraging, and it may enable more people to have access to this treatment option across various sites of care, including community settings.'

“在门诊环境中治疗患者的可能性令人鼓舞，并且这可能会让更多人在不同的护理场所，包括社区环境中获得这种治疗选择。”

The study also showed an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow-up of 5.8 months, in patients (n=42) treated with epcoritamab after only one prior line of systemic therapy. In patients treated with epcoritamab following two or more lines of systemic therapy (n=50), with a median follow-up of 10.8 months, the study showed an ORR of 60.0% and a CR rate of 38.0%.

该研究还显示，在仅接受过一线系统治疗后使用Epcoritamab治疗的患者（n=42）中，总体缓解率（ORR）为64.3%，完全缓解（CR）率为47.6%，中位随访时间为5.8个月。而在接受二线或更多线系统治疗后使用Epcoritamab的患者（n=50）中，中位随访时间为10.8个月，研究显示ORR为60.0%，CR率为38.0%。

Currently, epcoritamab is approved for R/R DLBCL after two or more prior lines of systemic therapy and is being investigated for use in earlier lines of therapy. See approved indication and important safety information below..

目前，epcoritamab 已获批用于接受过两种或更多先前系统治疗后的 R/R DLBCL，并正在研究其在更早期治疗中的应用。批准的适应症和重要的安全信息见下文。

'The updated EPCORE

更新后的EPCORE

NHL-6 trial findings presented at the Society of Hematologic Oncology Annual Meeting suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting. This potential shift to outpatient care could help improve access to treatment,' said .

NHL-6试验结果在血液肿瘤学会年会上公布，表明在门诊环境中使用epcoritamab治疗复发/难治性弥漫性大B细胞淋巴瘤可能是安全的。这种潜在的门诊治疗转变可能有助于提高治疗的可及性。

Svetlana Kobina

斯维特兰娜·科比纳

, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. 'AbbVie remains committed to building on our leadership in blood cancer, which includes advancing research with our partner Genmab, that firmly establishes the impact of investigational epcoritamab in successive lines of treatment across B-cell malignancies.'.

医学博士、哲学博士、艾伯维肿瘤医学事务副总裁表示：“艾伯维将继续致力于巩固我们在血液癌症领域的领导地位，这包括与合作伙伴Genmab共同推进研究，以充分验证在研药物epcoritamab在B细胞恶性肿瘤连续治疗中的影响。”

DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25-30% of all NHL cases.

DLBCL 是全球最常见的非霍奇金淋巴瘤 (NHL) 类型，约占所有 NHL 病例的 25%-30%。

In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.

在美国，每年大约有25,000例新诊断的DLBCL病例。

DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.

DLBCL 可以发生在淋巴结以及淋巴系统外的器官中，更常见于老年人，并且在男性中略为多发。

DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment.

DLBCL是一种快速增长的NHL（非霍奇金淋巴瘤），这是一种在淋巴系统中发展的癌症，影响B细胞淋巴细胞，一种白细胞。对于许多患有DLBCL的人来说，他们的癌症要么复发，这意味着它可能在治疗后再次出现，要么变得难治，意味着它对治疗没有反应。

Although new therapies have become available, management can still be challenging..

尽管已有新的治疗方法可用，但治疗仍然具有挑战性。

The use of epcoritamab in an outpatient setting for the first full dose in R/R DLBCL and as monotherapy in DLBCL in the second-line setting has not been approved by the U.S. FDA or any other Health Authority.

在复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）中门诊使用epcoritamab进行首次全剂量治疗，以及在二线治疗中作为单一疗法用于DLBCL，尚未获得美国FDA或其他任何卫生监管机构的批准。

About the EPCORE

关于EPCORE

NHL-6 Trial

NHL-6 试验

EPCORE

核心电商平台

NHL-6 is a Phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab as monotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The primary objective of the trial was to assess adverse events within three months of treatment initiation with epcoritamab monotherapy.

NHL-6是一项二期开放标签临床试验，评估在复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）成年患者中门诊给予皮下注射epcoritamab单药治疗的安全性。该试验的主要目的是在开始epcoritamab单药治疗的三个月内评估不良事件。

The primary outcome measures were the percentage of participants experiencing Grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events, and/or neurotoxicity (Ntox) events. Secondary outcomes included responses to treatment as determined by Lugano 2014 criteria and assessed by investigators..

主要结局指标是经历 3 级或更高级别细胞因子释放综合征 (CRS) 事件、免疫细胞相关神经毒性综合征 (ICANS) 事件和/或神经毒性 (Ntox) 事件的参与者百分比。次要结局包括根据 Lugano 2014 标准确定并由研究者评估的治疗反应。

EPCORE

核心工程计划

NHL-6 enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. At the time of data cutoff (

NHL-6 入组了92名接受过至少一种先前系统治疗（包括至少一种含抗CD20单克隆抗体的治疗）的复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者。在数据截止时 (

January 15, 2025

2025年1月15日

), 92 patients had received ≥1 dose of epcoritamab (community: n=41; academic: n=51). Median follow-up was 7.6 months (range, 6.0-9.2) and 50% remained on treatment. Median age was 69 years, 83% had

），92名患者接受了≥1剂epcoritamab（社区医院：n=41；学术机构：n=51）。中位随访时间为7.6个月（范围：6.0-9.2），50%的患者仍在接受治疗。中位年龄为69岁，83%的患者有

Ann Arbor

安娜堡

stage III-IV, 24% had prior CAR T, 24% had bulky disease ≥7cm, and 51% had International Prognostic Index (IPI) ≥3. More information can be found at

III-IV期，24%的患者之前接受过CAR T治疗，24%的患者有≥7cm的大包块病灶，51%的患者国际预后指数（IPI）≥3。更多信息可查阅

NCT05451810

NCT05451810

About Epcoritamab

关于Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody

Epcoritamab 是使用 Genmab 专有的 DuoBody 技术创建的 IgG1 双特异性抗体

technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells..

技术和皮下给药。Genmab的DuoBody-CD3技术旨在引导细胞毒性T细胞选择性地引发对目标细胞类型的免疫反应。Epcoritamab旨在同时结合T细胞上的CD3和B细胞上的CD20，并诱导T细胞介导的CD20+细胞杀伤。

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

Epcoritamab由Genmab和AbbVie共同开发，作为双方在肿瘤领域合作的一部分。两家公司在美国共同承担商业责任，并且

Japan

日本

, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

，AbbVie负责进一步的全球商业化。两家公司都将寻求针对研究性R/R FL适应症的更多国际监管批准，以及针对R/R DLBCL适应症的更多批准。

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (.

Genmab和AbbVie继续评估epcoritamab作为单药疗法及联合疗法在多种血液恶性肿瘤中的应用。这包括五项正在进行的III期、开放标签、随机试验，其中一项试验正在评估epcoritamab单药治疗与研究者选择的化疗相比，在R/R DLBCL患者中的效果。

NCT04628494

NCT04628494

), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (

），一项评估epcoritamab联合R-CHOP用于新诊断的DLBCL成人患者的试验（

NCT05578976

NCT05578976

), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (

），一项评估epcoritamab联合利妥昔单抗和来那度胺（R2）治疗复发/难治性滤泡性淋巴瘤（R/R FL）患者的试验（

NCT05409066

NCT05409066

), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (

），一项评估epcoritamab联合利妥昔单抗和来那度胺（R2）与化疗免疫疗法在既往未治疗的FL患者中的对比试验（

NCT06191744

NCT06191744

), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (

），以及一项评估epcoritamab联合来那度胺与化疗输注在R/R DLBCL患者中的对比试验（

NCT06508658

NCT06508658

). The safety and efficacy of epcoritamab have not been established for these investigational uses.

）。Epcoritamab 的安全性和有效性在这些研究用途中尚未得到证实。

EPKINLY

艾匹克拉

(epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION

（epcoritamab-bysp）美国适应症及重要安全信息

What is EPKINLY?

什么是EPKINLY？

EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data.

EPKINLY 是一种处方药，用于治疗患有某些类型弥漫性大B细胞淋巴瘤（DLBCL）、高级别B细胞淋巴瘤或滤泡性淋巴瘤（FL）的成人患者，这些患者的疾病在之前接受过两种或以上治疗后复发或未能响应之前的治疗。EPKINLY 的批准基于患者反应数据。

Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children..

研究正在进行中，以确认EPKINLY的临床益处。目前尚不清楚EPKINLY在儿童中是否安全有效。

About AbbVie in Oncology

关于艾伯维在肿瘤学领域

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.

AbbVie致力于提升护理标准，并为全球难以治疗的癌症患者带来变革性的疗法。我们正在推进一系列癌症类型的血液癌和实体瘤的研究疗法的动态管线。我们专注于创造靶向药物，这些药物要么阻止癌细胞的复制，要么促使它们被清除。

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..

我们通过各种有针对性的治疗方式和生物干预措施来实现这一目标，包括小分子治疗药物、抗体药物偶联物 (ADC)、基于免疫肿瘤学的治疗药物、多特异性抗体以及新型 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，加速潜在突破性药物的交付进程。

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.

如今，我们庞大的肿瘤学产品组合包括已获批和正在研究的针对多种血液癌症和实体瘤的治疗方法。我们正在针对一些世界上最为普遍和致残的癌症进行多项临床试验，评估超过35种在研药物。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。

About AbbVie

艾伯维公司简介

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.

艾伯维的使命是发现并提供创新的药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科护理在内的几个关键治疗领域对人们的生活产生显著影响，以及我们艾尔建美学产品组合中的产品和服务。