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Genmab to Present New and Updated Results From Multiple Clinical Trials Evaluating Epcoritamab Across Various B-Cell Malignancies at the 2024 European Hematology Association (EHA) Congress

Genmab to Present New and Updated Results From Multiple Clinical Trials Evaluating Epcoritamab Across Various B-Cell Malignancies at the 2024 European Hematology Association (EHA) Congress

Genmab将在2024年欧洲血液学协会(EHA)大会上公布评估Epcoritamab在各种B细胞恶性肿瘤中的多项临床试验的新结果和更新的结果
GlobeNewswire ·  05/14 22:02

Media Release
COPENHAGEN, Denmark; May 14, 2024

媒体发布
丹麦哥本哈根;2024 年 5 月 14 日

  • Sixteen abstracts accepted for presentation and publication demonstrate depth and breadth of comprehensive epcoritamab development program
  • Three oral presentations highlight novel data evaluating epcoritamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL), in combination for first-line treatment of diffuse large B-cell lymphoma (DLBCL), and in Richter's transformation (RT)
  • 十六份获准发表和发表的摘要展示了全面的epcoritamab开发计划的深度和广度
  • 三场口头陈述重点介绍了评估复发/难治性(R/R)滤泡性淋巴瘤(FL)患者、用于弥漫性大B细胞淋巴瘤(DLBCL)一线治疗以及里希特转化(RT)患者中依普利他单抗的新数据

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2024 European Hematology Association (EHA) Congress, being held in Madrid, Spain and virtually, June 13-16, 2024.

Genmab A/S(纳斯达克股票代码:GMAB)今天宣布,将在2024年6月13日至16日在西班牙马德里举行的2024年欧洲血液学协会(EHA)大会上发布多份评估epcoritamab(一种使用皮下给药的T细胞双特异性抗体)的摘要。

Presentations will include data from clinical trials evaluating the safety and efficacy of epcoritamab as a monotherapy and in combination with standard-of-care or other novel therapies across multiple patient populations. Three oral presentations will highlight data from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory follicular lymphoma (FL), from EPCORE NHL-5 evaluating epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as a potential first-line treatment regimen for patients with diffuse large B-cell lymphoma (and DLBCL), and from EPCORE CLL-1 evaluating epcoritamab in patients with Richter's transformation (RT). All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library.

演讲将包括来自临床试验的数据,这些试验评估了epcoritamab作为单一疗法以及与标准护理或其他新疗法联合用于多个患者群体的安全性和有效性。三场口头演讲将重点介绍EPCORE NHL-1 评估复发/难治性滤泡淋巴瘤(FL)患者依普利他单抗的关键和第一周期剂量优化队列的数据,这些数据来自评估依普利他单抗与泊拉妥珠单抗、利妥昔单抗、环磷酰胺、多柔比星和泼尼松(Pola-R-R-Prednisone)联合使用的 EPCORE NHL-5 CHP)作为弥漫性大B细胞淋巴瘤(和DLBCL)患者的潜在一线治疗方案,来自EPCORE CLL-1,用于评估里希特转化(RT)患者中的依普利他单抗。所有获准发表的摘要均已出版,可通过EHA开放获取图书馆在线访问。

"Building on the recent global regulatory approvals and pending regulatory decisions for epcoritamab, we look forward to presenting new data at EHA 2024 that highlight the key progress that has been made developing epcoritamab as a potential core therapy across a variety of B-cell malignances," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we are committed to advancing and evolving the robust development program evaluating epcoritamab, as a monotherapy and in combination, across B-cell malignancies and settings."

Genmab 执行副总裁兼首席开发官朱迪思·克里莫夫斯基博士表示:“在最近全球监管批准和尚待批准的依普利他单抗的监管决定的基础上,我们期待在 EHA 2024 上公布新数据,这些数据重点介绍在开发依普利他单抗作为治疗各种B细胞恶性肿瘤的潜在核心疗法方面取得的关键进展。”“我们与AbbVie一起,致力于推进和完善评估epcoritamab作为单一疗法和组合疗法的强大开发计划,涵盖B细胞恶性肿瘤和环境。”

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

这些研究用途的安全性和有效性尚未确定。

Abstracts accepted for presentation at EHA:

获准在 EHA 上提交的摘要:

Clinical Research

临床研究

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S163 Single-Agent Epcoritamab Leads to Deep Responses in Patients (pts) with Richter's Transformation (RT): Primary Results from the EPCORE CLL-1 Trial Oral Friday, June 14, 14:45-16:00 CEST
S239 First Data from Subcutaneous Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for First-line Diffuse Large B-Cell Lymphoma (DLBCL): EPCORE NHL-5 Oral Friday, June 14, 14:45-16:00 CEST
S234 Epcoritamab Induces Deep Responses in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Safety and Pooled Efficacy Data from EPCORE NHL 1 Pivotal and Cycle (C) 1 Optimization (Opt) FL Cohorts Oral Saturday, June 15, 16:30-17:45 CEST
P1146 Epcoritamab with Rituximab + Lenalidomide (R2) in Previously Untreated (1L) Follicular Lymphoma (FL) and Epcoritamab Maintenance Therapy in FL: EPCORE NHL 2 Arms 6 and 7 Poster Friday, June 14, 18:00-19:00 CEST
P1151 Extended Follow-Up Beyond 2.5 Years Shows Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P1152 Epcoritamab + GemOx Induces Deep, Durable Responses in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma: Updated Results From the EPCORE NHL-2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P1161 Epcoritamab + R-DHAX/C Elicits Deep, Durable Responses in Transplant-Eligible Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Including High-Risk Disease Poster Friday, June 14, 18:00-19:00 CEST
PB2955 EPCORE FL-2: Phase 3 Trial of Epcoritamab with Rituximab and Lenalidomide (R2) vs Chemoimmunotherapy or R2 in Previously Untreated Follicular Lymphoma Electronic Publication Friday, June 14, 9:00 CEST
摘要编号 摘要标题 演示文稿类型 演示日期/时间
S163 单一药物 Epcoritamab 通过里希特转化 (RT) 导致患者(pts)的深度反应:EPCORE CLL-1 试验的主要结果 口服 欧洲中部标准时间6月14日星期五 14:45-16:00
S239 来自皮下 Eporitamab + Polatuzumab Vedotin、利妥昔单抗、环磷酰胺、多柔比星和泼尼松(Pola-R-CHP)治疗一线弥漫性大 B 细胞淋巴瘤(DLBCL)的首批数据:EPCORE NHL-5 口服 欧洲中部标准时间6月14日星期五 14:45-16:00
S234 Epcoritamab 可诱导复发或难治性(R/R)滤泡性淋巴瘤(FL)的深度反应:来自 EPCORE NHL 1 关键和周期(C)1 优化(可选)FL 队列的安全性和合并疗效数据 口服 6月15日星期六,欧洲中部标准时间 16:30-17:45
第 1146 页 Epcoritamab 与利妥昔单抗 + 来那度胺 (R2) 用于先前未经治疗的 (1L) 滤泡性淋巴瘤 (FL) 和佛罗里达州依普利他单抗维持疗法:EPCORE NHL 2 Arms 6 和 7 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1151 超过2.5年的长期随访显示Epcoritamab单一疗法对复发或难治性大B细胞淋巴瘤的完全应答者具有长期疗效 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1152 Epcoritamab + GemoX 在复发或难治性弥漫性大 B 细胞淋巴瘤患者中诱发深度、持久的反应:EPCORE NHL-2 试验的最新结果 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1161 Epcoritamab + R-DHAX/C 在符合移植条件的复发或难治性弥漫性大 B 细胞淋巴瘤(包括高风险疾病)患者中引发深入、持久的反应 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
PB2955 EPCORE FL-2:使用利妥昔单抗和来那度胺进行依考利他单抗的三期试验(R2) 与化学免疫疗法或 R 对比2 在以前未经治疗的滤泡性淋巴瘤中 电子出版物 欧洲中部标准时间6月14日星期五 9:00

Outcomes Research

结果研究

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1114 Patient-Reported Outcomes in Patients with Relapsed or Refractory Follicular Lymphoma Treated With Epcoritamab Poster Friday, June 14, 18:00-19:00 CEST
P1121 Matching-Adjusted Indirect Comparisons of Epcoritamab vs Mosunetuzumab or Odronextamab in Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies Poster Friday, June 14, 18:00-19:00 CEST
P1140 The Efficacy of Subcutaneous Epcoritamab vs Standard-of-Care (SCHOLAR-5) in Patients With Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies: An Indirect Treatment Comparison Poster Friday, June 14, 18:00-19:00 CEST
P1133 Comparative Effectiveness of Epcoritamab versus Real-World Usual Care in Relapsed/Refractory Follicular Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P2081 Logistical Challenges Associated with Chimeric Antigen Receptor T-Cell Therapy (CAR T) in Non-Hodgkin Lymphoma (NHL): A Survey of Healthcare Professionals Electronic Poster Friday, June 14, 9:00 CEST
摘要编号 摘要标题 演示文稿类型 演示日期/时间
P1114 患者报告的Eporitamab治疗复发或难治性滤泡性淋巴瘤患者的预后 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1121 经匹配调整的间接比较依普利他单抗与莫苏尼妥珠单抗或奥多内他单抗治疗后复发/难治性滤泡性淋巴瘤的间接比较 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1140 皮下依普利他单抗与标准护理(SCHOLAR-5)对经≥2次全身治疗后复发/难治性滤泡性淋巴瘤患者的疗效:间接治疗比较 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P1133 Epcoritamab与现实世界常规护理在复发/难治性滤泡性淋巴瘤中的比较疗效 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P2081 与非霍奇金淋巴瘤 (NHL) 嵌合抗原受体 T 细胞疗法 (CAR T) 相关的后勤挑战:医疗保健专业人员调查 电子海报 欧洲中部标准时间6月14日星期五 9:00

Pharmacokinetic/Translational Research

药代动力学/转化研究

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1244 Immune Correlates of Response to Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Dose Expansion in a Phase 1/2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P2059 Minimal Residual Disease (MRD), Pharmacokinetic (PK), and Pharmacodynamic (PD) Assessment of Epcoritamab 2-vs 3-step Step-up Dosing in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) Electronic Poster Friday, June 14, 9:00 CEST
P2060 Model-Based Cycle (C) 1 Optimization of Step-Up Dose Regimen For Epcoritamab in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Electronic Poster Friday, June 14, 9:00 CEST
摘要编号 摘要标题 演示文稿类型 演示日期/时间
P1244 复发或难治性弥漫性大 B 细胞淋巴瘤患者对依普利他单抗反应的免疫相关性:1/2 期试验中的剂量扩大 海报 欧洲中部标准时间6月14日星期五 18:00-19:00
P2059 复发/难治性滤泡性淋巴瘤(R/R FL)患者Epcoritamab的两步加压给药的最小残留疾病(MRD)、药代动力学(PK)和药效学(PD)评估 电子海报 欧洲中部标准时间6月14日星期五 9:00
P2060 基于模型的周期 (C) 1 优化复发或难治性 (R/R) 滤泡性淋巴瘤 (FL) 患者依普利他单抗的增量剂量方案 电子海报 欧洲中部标准时间6月14日星期五 9:00

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

关于 Epcoritamab
Epcoritamab 是一种 IgG1 双特异性抗体,使用 Genmab 的专有 DuoBody 制成 技术和皮下给药。Genmab 的 duoBody-CD3 技术旨在选择性地引导细胞毒性 T 细胞,以引发对靶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+ 细胞杀死。

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Epcoritamab已在多个地区的某些淋巴瘤适应症中获得监管部门的批准。美国、欧盟或任何其他地区均未批准在佛罗里达州使用依普利他单抗。作为两家公司肿瘤学合作的一部分,Epcoritamab由Genmab和AbbVie共同开发。两家公司将在美国和日本分担商业责任,艾伯维负责进一步的全球商业化。

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 four 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 (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

Genmab 和 AbbVie 继续评估将依普利他单抗作为单一疗法的使用,以及联合使用在一系列血液系统恶性肿瘤中的跨线疗法。这包括四项正在进行的3期开放标签随机试验,包括一项评估依普利他单抗与研究者选择的化疗对比的试验(NCT:04628494),一项评估依普利他单抗联合R-CHOP对新诊断的DLBCL的成年参与者的试验(NCT:05578976),一项评估依普利他单抗联合应用于新诊断的DLBCL的成年参与者的试验(NCT:05578976),一项评估依普利他单抗联合应用于新诊断的DLBCL的成年参与者的试验(NCT:05578976)利妥昔单抗和来那度胺治疗复发/难治性流感患者(NCT:05409066),以及一项评估依普利他单抗联合利妥昔单抗和来那度胺(R2)与化疗相比的试验用于先前未接受治疗的 FL 患者(NCT:06191744)。尚未确定依普利他单抗在这些研究用途中的安全性和有效性。请访问 clinicaltrials.gov 了解更多信息。

About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative, and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines.

关于 Genmab
Genmab 是一家国际生物技术公司,其核心目标是指导其不可阻挡的团队努力通过创新的差异化抗体疗法改善患者的生活。25年来,其充满激情、富有创新精神和协作精神的团队发明了下一代抗体技术平台,并利用了转换、定量和数据科学,形成了包括双特异性T细胞参与剂、下一代免疫检查点调节剂、效应器功能增强抗体和抗体药物偶联物在内的专有产品线。为了帮助开发和向患者提供新型抗体疗法,Genmab已与生物技术和制药公司建立了20多个战略合作伙伴关系。到2030年,Genmab 的愿景是通过 knocks-off(KYSO)来改变癌症和其他严重疾病患者的生活)抗体药物。

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab 成立于 1999 年,总部位于丹麦哥本哈根,在荷兰乌得勒支、美国新泽西州普林斯顿和日本东京设有分支机构。欲了解更多信息,请访问 Genmab.com 并在 LinkedIn 和 X 上关注我们。

Contact:
David Freundel, Senior Director, Product Communications
T: +1 609 430 2481; E: dafr@genmab.com

联系人:
David Freundel,产品传播高级董事
电话:+1 609 430 2481;E:dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
This Media Release contains forward looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

安德鲁·卡尔森,副总裁,投资者关系主管
电话:+45 3377 9558;E:acn@genmab.com
本新闻稿包含前瞻性声明。“相信”、“期望”、“预测”、“打算” 和 “计划” 等词以及类似的表述表示前瞻性陈述。实际结果或业绩可能与此类陈述所表达或暗示的任何未来业绩或业绩存在重大差异。可能导致我们的实际结果或业绩出现重大差异的重要因素包括与产品的临床前和临床开发相关的风险、与临床试验结果和进行相关的不确定性,包括不可预见的安全问题、与产品制造相关的不确定性、我们的产品缺乏市场接受度、我们无法管理增长、与我们的业务领域和市场相关的竞争环境、我们无法吸引和留住合格的人员,我们的专利和专有权利、我们与附属实体的关系、可能使我们的产品或技术过时的技术变化和发展以及其他因素的不可执行性或缺乏保护。有关这些风险的进一步讨论,请参阅Genmab最新财务报告中的风险管理部分,这些报告可在以下网址查阅 以及 Genmab 最新的 20-F 表年度报告和其他文件中包含的风险因素 与美国证券交易委员会 (SEC) 联系,可在以下网址获得 www.sec.gov。除非法律要求,否则Genmab不承担任何义务更新或修改本新闻稿中的前瞻性陈述,也没有义务确认此类声明以反映发布之后的后续事件或情况或与实际业绩相关的情况。

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; HexaBody; DuoHexaBody, HexElectand KYSO. EPCORE, EPKINLY, TEPKINLY and their designs are trademarks of AbbVie Biotechnology Ltd.

Genmab A/S 和/或其子公司拥有以下商标:Genmab; Y 形的 Genmab 徽标; Genmab 与 Y 形的 Genmab 徽标相结合; HuMax; duoBody; HexAbody; duoHexBody,Hexelect还有 KYSO。 EPCORE, 令人毛骨悚然地,TEPKINLY 而且它们的设计是艾伯维生物技术有限公司的商标


i Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625.

Engelberts PJ、Hiemstra IH、de Jong B 等在临床前模型中,duobody-CD3xCD20诱导强效的T细胞介导杀死恶性B细胞,并为皮下给药提供了机会。 电子生物医学. 2020; 52:102625. doi: 10.1016/j.ebiom.2019.102625。

Media Release no. i05
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

新闻稿编号:i05
CVR 号 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Genmab A/S
卡尔·雅各布森的 Vej 30
2500 Valby
丹麦

Attachment

附件

  • 140524_MRi05_Genmab EHA 2024 Curtain Raiser Press Release
  • 140524_mri05_Genmab EHA 2024 Curtain Raiser 新闻稿

译文内容由第三方软件翻译。


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