Genmab A/S announced today its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), following at least one prior systemic therapy. .

Genmab A/S 今天宣布，计划在 2025 年上半年向美国食品药物监督管理局 (FDA) 提交一份补充生物制品许可申请 (sBLA)，用于皮下注射的 epcoritamab。这种双特异性抗体正被研究与利妥昔单抗和来那度胺 (R2) 联合使用，以治疗既往至少接受过一种系统性治疗的复发或难治性 (R/R) 滤泡性淋巴瘤 (FL) 成年患者。

The decision to submit the sBLA is supported by positive topline results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab plus R2 versus R2 alone in adult patients with R/R FL. Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001).

提交sBLA的决定得到了3期EPCORE FL-1试验的积极顶线结果的支持，该试验评估了epcoritamab联合R2与单独使用R2在成人R/R FL患者中的效果。根据独立数据监查委员会（IDMC）进行的中期分析，该研究达到了其双重主要终点之一的ORR（完全缓解加部分缓解，p值<0.0001）。

The safety profile of epcoritamab plus R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The full results will be submitted later this year for presentation at an upcoming medical congress and discussed with global regulatory authorities. .

Epcoritamab联合R2在复发/难治性滤泡性淋巴瘤（R/R FL）成人患者中的安全性特征与各单独方案（epcoritamab和R2）的已知安全性特征一致，并与美国epcoritamab处方信息中描述的一致。未观察到新的安全性信号。完整结果将在今年晚些时候提交，并在即将召开的医学大会上展示，同时将与全球监管机构进行讨论。

“We are pleased with the strength of the data that allows us to submit a supplemental Biologics License Application in accordance with the U.S. FDA’s Project Frontrunner, which supports our commitment to advance novel medicines to patients who need them. The interim topline results demonstrate the potential of this investigational epcoritamab combination regimen to treat relapsed or refractory follicular lymphoma patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab.

“我们对数据的力度感到满意，这使我们能够根据美国FDA的Project Frontrunner提交补充生物制品许可申请，这也支持了我们将新型药物带给需要的患者的承诺。初步的顶线结果展示了这种在研的epcoritamab联合治疗方案在治疗复发或难治性滤泡性淋巴瘤患者方面的潜力。”Genmab首席执行官Jan van de Winkel博士表示。

“This milestone represents our commitment to the ongoing development of epcoritamab, with our partner AbbVie, and we look forward to seeing the full results from the study.”.

“这一里程碑代表了我们与合作伙伴艾伯维对epcoritamab持续开发的承诺，我们期待看到这项研究的完整结果。”

Use of epcoritamab plus R2 in R/R FL is not approved in the U.S., in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R/R FL after two or more lines of systemic therapy..

Epcoritamab联合R2用于治疗复发/难治性滤泡性淋巴瘤（R/R FL）尚未在美国、欧盟或任何其他地区获得批准。Epcoritamab作为滤泡性淋巴瘤（FL）联合疗法的安全性和有效性尚未确立。目前，Epcoritamab已获得FDA的加速批准，作为单药疗法用于治疗经过两次或以上系统治疗的成人复发/难治性滤泡性淋巴瘤（R/R FL）。

About Follicular Lymphoma (FL)

关于滤泡性淋巴瘤（FL）

FL is typically an indolent (or slow-growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases.i About 15,000 people develop FL each year in the U.S.ii and it is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse the remission and time to next treatment is shorter.iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v.

滤泡性淋巴瘤（FL）通常是一种惰性（或缓慢生长）的非霍奇金淋巴瘤（NHL），起源于B淋巴细胞，是第二常见的NHL类型，占所有病例的20-30%。i 每年约有15,000人在美国被诊断出患有FL。ii 目前的标准治疗方法尚无法治愈该疾病。iii 患者常出现复发，且每次复发后的缓解期和下次治疗的时间间隔会越来越短。iv 随着时间推移，超过25%的FL患者可能发生转化为弥漫性大B细胞淋巴瘤（DLBCL）的情况，v 这是一种侵袭性较强的NHL类型，与较差的生存结果相关。

About the EPCORE FL-1 Trial

关于EPCORE FL-1试验

EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and progression-free survival assessed by independent review committee (IRC) per Lugano criteria..

EPCORE FL-1 (NCT05409066) 是一项 III 期开放标签干预性试验，旨在评估依帕伐单抗联合利妥昔单抗和来那度胺（R2）对比单独使用 R2 在复发/难治性（R/R）滤泡性淋巴瘤（FL）患者中的安全性和有效性。双重主要终点是根据卢加诺标准由独立审查委员会（IRC）评估的总缓解率（ORR）和无进展生存期（PFS）。

About Epcoritamab

关于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.vi .

Epcoritamab 是一种使用 Genmab 专有的 DuoBody® 技术制造的 IgG1 双特异性抗体，通过皮下注射给药。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 能够同时结合 T 细胞上的 CD3 和 B 细胞上的 CD20，并诱导 T 细胞介导的对 CD20+ 细胞的杀伤作用。

Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. 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.

Epcoritamab（在美国和日本以商品名EPKINLY®获批，在欧盟以TEPKINLY®获批）已在某些地区获得特定淋巴瘤适应症的监管批准。Epcoritamab由Genmab和AbbVie共同开发，作为双方在肿瘤领域合作的一部分。两家公司将在美国共同承担商业责任。

and Japan, 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. .

和日本，艾伯维负责进一步的全球商业化。两家公司都将寻求额外的国际监管批准，用于研究性的R/R FL适应症，并为R/R DLBCL适应症获取更多批准。

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 (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658).

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，其中包括：一项评估epcoritamab单药治疗与研究者选择的化疗方案在复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者中的比较试验（NCT04628494）；一项评估epcoritamab联合R-CHOP方案用于初诊DLBCL成年患者的试验（NCT05578976）；一项评估epcoritamab联合利妥昔单抗和来那度胺（R2）在复发/难治性滤泡性淋巴瘤（R/R FL）患者中的试验（NCT05409066）；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FL患者中的比较试验（NCT06191744）；以及一项评估epcoritamab联合来那度胺与化疗输注在R/R DLBCL患者中的比较试验（NCT06508658）。

The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information..

Epcoritamab 的安全性和有效性在这些研究性用途中尚未得到证实。有关更多信息，请访问 www.clinicaltrials.gov。

About Genmab

关于Genmab

Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 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, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies.

Genmab是一家国际生物技术公司，其核心目标是引导其不懈努力的团队通过创新和差异化的抗体疗法改善患者的生活。在过去的25年多时间里，其充满热情、创新和协作精神的团队发明了下一代抗体技术平台，并利用转化、定量和数据科学，构建了一条包括双特异性T细胞接合器、抗体药物偶联物、下一代免疫检查点调节剂和效应功能增强型抗体在内的自主产品管线。

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®. .

到 2030 年，Genmab 的愿景是通过令人惊艳 (KYSO) 的抗体药物®，改变癌症及其他重症患者的生活。

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. 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，在北美、欧洲和亚太地区均有业务。欲了解更多信息，请访问 Genmab.com 并在 LinkedIn 和 X 上关注我们。

Contact:

联系：

Marisol Mendez Peron, Senior Vice President, Global Communications & Corporate Affairs

玛丽索尔·门德斯·贝隆，全球传播与企业事务高级副总裁

T: +1 609 955-2392; E: mmp@genmab.com

电话：+1 609 955-2392；电子邮件：mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

安德鲁·卡森，副总裁，投资者关系主管

T: +45 3377 9558; E: acn@genmab.com

电话：+45 3377 9558；邮箱：acn@genmab.com

Source: ir.genmab.com

来源：ir.genmab.com