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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將在2024年歐洲血液學協會(EHA)大會上公佈評估Epcoritamab在各種B細胞惡性腫瘤中的多項臨床試驗的新結果和更新的結果
GlobeNewswire ·  05/14 10:02

Media Release
COPENHAGEN, Denmark; May 14, 2024

媒體發佈
丹麥哥本哈根;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)
  • 十六份獲准發表和發表的摘要展示了全面的epcoritamab開發計劃的深度和廣度
  • 三場口頭陳述重點介紹了評估復發/難治性(R/R)濾泡性淋巴瘤(FL)患者、用於瀰漫性大B細胞淋巴瘤(DLBCL)一線治療以及裏希特轉化(RT)患者中依普利他單抗的新數據

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(納斯達克股票代碼:GMAB)今天宣佈,將在2024年6月13日至16日在西班牙馬德里舉行的2024年歐洲血液學協會(EHA)大會上發佈多份評估epcoritamab(一種使用皮下給藥的T細胞雙特異性抗體)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.

演講將包括來自臨床試驗的數據,這些試驗評估了epcoritamab作爲單一療法以及與標準護理或其他新療法聯合用於多個患者群體的安全性和有效性。三場口頭演講將重點介紹EPCORE NHL-1 評估復發/難治性濾泡淋巴瘤(FL)患者依普利他單抗的關鍵和第一週期劑量優化隊列的數據,這些數據來自評估依普利他單抗與泊拉妥珠單抗、利妥昔單抗、環磷酰胺、多柔比星和潑尼松(Pola-R-R-Prednisone)聯合使用的 EPCORE NHL-5 CHP)作爲瀰漫性大B細胞淋巴瘤(和DLBCL)患者的潛在一線治療方案,來自EPCORE CLL-1,用於評估裏希特轉化(RT)患者中的依普利他單抗。所有獲准發表的摘要均已出版,可通過EHA開放獲取圖書館在線訪問。

"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 執行副總裁兼首席開發官朱迪思·克里莫夫斯基博士表示:“在最近全球監管批准和尚待批准的依普利他單抗的監管決定的基礎上,我們期待在 EHA 2024 上公佈新數據,這些數據重點介紹在開發依普利他單抗作爲治療各種B細胞惡性腫瘤的潛在覈心療法方面取得的關鍵進展。”“我們與AbbVie一起,致力於推進和完善評估epcoritamab作爲單一療法和組合療法的強大開發計劃,涵蓋B細胞惡性腫瘤和環境。”

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

這些研究用途的安全性和有效性尚未確定。

Abstracts accepted for presentation at EHA:

獲准在 EHA 上提交的摘要:

Clinical Research

臨床研究

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
摘要編號 摘要標題 演示文稿類型 演示日期/時間
S163 單一藥物 Epcoritamab 通過裏希特轉化 (RT) 導致患者(pts)的深度反應:EPCORE CLL-1 試驗的主要結果 口服 歐洲中部標準時間6月14日星期五 14:45-16:00
S239 來自皮下 Eporitamab + Polatuzumab Vedotin、利妥昔單抗、環磷酰胺、多柔比星和潑尼松(Pola-R-CHP)治療一線瀰漫性大 B 細胞淋巴瘤(DLBCL)的首批數據:EPCORE NHL-5 口服 歐洲中部標準時間6月14日星期五 14:45-16:00
S234 Epcoritamab 可誘導復發或難治性(R/R)濾泡性淋巴瘤(FL)的深度反應:來自 EPCORE NHL 1 關鍵和週期(C)1 優化(可選)FL 隊列的安全性和合並療效數據 口服 6月15日星期六,歐洲中部標準時間 16:30-17:45
第 1146 頁 Epcoritamab 與利妥昔單抗 + 來那度胺 (R2) 用於先前未經治療的 (1L) 濾泡性淋巴瘤 (FL) 和佛羅里達州依普利他單抗維持療法:EPCORE NHL 2 Arms 6 和 7 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1151 超過2.5年的長期隨訪顯示Epcoritamab單一療法對復發或難治性大B細胞淋巴瘤的完全應答者具有長期療效 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1152 Epcoritamab + GemoX 在復發或難治性瀰漫性大 B 細胞淋巴瘤患者中誘發深度、持久的反應:EPCORE NHL-2 試驗的最新結果 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1161 Epcoritamab + R-DHAX/C 在符合移植條件的復發或難治性瀰漫性大 B 細胞淋巴瘤(包括高風險疾病)患者中引發深入、持久的反應 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
PB2955 EPCORE FL-2:使用利妥昔單抗和來那度胺進行依考利他單抗的三期試驗(R2) 與化學免疫療法或 R 對比2 在以前未經治療的濾泡性淋巴瘤中 電子出版物 歐洲中部標準時間6月14日星期五 9:00

Outcomes Research

結果研究

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
摘要編號 摘要標題 演示文稿類型 演示日期/時間
P1114 患者報告的Eporitamab治療復發或難治性濾泡性淋巴瘤患者的預後 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1121 經匹配調整的間接比較依普利他單抗與莫蘇尼妥珠單抗或奧多內他單抗治療後復發/難治性濾泡性淋巴瘤的間接比較 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1140 皮下依普利他單抗與標準護理(SCHOLAR-5)對經≥2次全身治療後復發/難治性濾泡性淋巴瘤患者的療效:間接治療比較 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P1133 Epcoritamab與現實世界常規護理在復發/難治性濾泡性淋巴瘤中的比較療效 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P2081 與非霍奇金淋巴瘤 (NHL) 嵌合抗原受體 T 細胞療法 (CAR T) 相關的後勤挑戰:醫療保健專業人員調查 電子海報 歐洲中部標準時間6月14日星期五 9:00

Pharmacokinetic/Translational Research

藥代動力學/轉化研究

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
摘要編號 摘要標題 演示文稿類型 演示日期/時間
P1244 復發或難治性瀰漫性大 B 細胞淋巴瘤患者對依普利他單抗反應的免疫相關性:1/2 期試驗中的劑量擴大 海報 歐洲中部標準時間6月14日星期五 18:00-19:00
P2059 復發/難治性濾泡性淋巴瘤(R/R FL)患者Epcoritamab的兩步加壓給藥的最小殘留疾病(MRD)、藥代動力學(PK)和藥效學(PD)評估 電子海報 歐洲中部標準時間6月14日星期五 9:00
P2060 基於模型的週期 (C) 1 優化復發或難治性 (R/R) 濾泡性淋巴瘤 (FL) 患者依普利他單抗的增量劑量方案 電子海報 歐洲中部標準時間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

關於 Epcoritamab
Epcoritamab 是一種 IgG1 雙特異性抗體,使用 Genmab 的專有 DuoBody 製成 技術和皮下給藥。Genmab 的 duoBody-CD3 技術旨在選擇性地引導細胞毒性 T 細胞,以引發對靶細胞類型的免疫反應。Epcoritamab 旨在同時結合 T 細胞上的 CD3 和 B 細胞上的 CD20,並誘導 T 細胞介導的 CD20+ 細胞殺死。

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已在多個地區的某些淋巴瘤適應症中獲得監管部門的批准。美國、歐盟或任何其他地區均未批准在佛羅里達州使用依普利他單抗。作爲兩家公司腫瘤學合作的一部分,Epcoritamab由Genmab和AbbVie共同開發。兩家公司將在美國和日本分擔商業責任,艾伯維負責進一步的全球商業化。

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 繼續評估將依普利他單抗作爲單一療法的使用,以及聯合使用在一系列血液系統惡性腫瘤中的跨線療法。這包括四項正在進行的3期開放標籤隨機試驗,包括一項評估依普利他單抗與研究者選擇的化療對比的試驗(NCT:04628494),一項評估依普利他單抗聯合R-CHOP對新診斷的DLBCL的成年參與者的試驗(NCT:05578976),一項評估依普利他單抗聯合應用於新診斷的DLBCL的成年參與者的試驗(NCT:05578976),一項評估依普利他單抗聯合應用於新診斷的DLBCL的成年參與者的試驗(NCT:05578976)利妥昔單抗和來那度胺治療復發/難治性流感患者(NCT:05409066),以及一項評估依普利他單抗聯合利妥昔單抗和來那度胺(R2)與化療相比的試驗用於先前未接受治療的 FL 患者(NCT:06191744)。尚未確定依普利他單抗在這些研究用途中的安全性和有效性。請訪問 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.

關於 Genmab
Genmab 是一家國際生物技術公司,其核心目標是指導其不可阻擋的團隊努力通過創新的差異化抗體療法改善患者的生活。25年來,其充滿激情、富有創新精神和協作精神的團隊發明了下一代抗體技術平台,並利用了轉換、定量和數據科學,形成了包括雙特異性T細胞參與劑、下一代免疫檢查點調節劑、效應器功能增強抗體和抗體藥物偶聯物在內的專有產品線。爲了幫助開發和向患者提供新型抗體療法,Genmab已與生物技術和製藥公司建立了20多個戰略合作伙伴關係。到2030年,Genmab 的願景是通過 knocks-off(KYSO)來改變癌症和其他嚴重疾病患者的生活)抗體藥物。

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 成立於 1999 年,總部位於丹麥哥本哈根,在荷蘭烏得勒支、美國新澤西州普林斯頓和日本東京設有分支機構。欲了解更多信息,請訪問 Genmab.com 並在 LinkedIn 和 X 上關注我們。

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

聯繫人:
David Freundel,產品傳播高級董事
電話:+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.

安德魯·卡爾森,副總裁,投資者關係主管
電話:+45 3377 9558;E:acn@genmab.com
本新聞稿包含前瞻性聲明。“相信”、“期望”、“預測”、“打算” 和 “計劃” 等詞以及類似的表述表示前瞻性陳述。實際結果或業績可能與此類陳述所表達或暗示的任何未來業績或業績存在重大差異。可能導致我們的實際結果或業績出現重大差異的重要因素包括與產品的臨床前和臨床開發相關的風險、與臨床試驗結果和進行相關的不確定性,包括不可預見的安全問題、與產品製造相關的不確定性、我們的產品缺乏市場接受度、我們無法管理增長、與我們的業務領域和市場相關的競爭環境、我們無法吸引和留住合格的人員,我們的專利和專有權利、我們與附屬實體的關係、可能使我們的產品或技術過時的技術變化和發展以及其他因素的不可執行性或缺乏保護。有關這些風險的進一步討論,請參閱Genmab最新財務報告中的風險管理部分,這些報告可在以下網址查閱 以及 Genmab 最新的 20-F 表年度報告和其他文件中包含的風險因素 與美國證券交易委員會 (SEC) 聯繫,可在以下網址獲得 www.sec.gov。除非法律要求,否則Genmab不承擔任何義務更新或修改本新聞稿中的前瞻性陳述,也沒有義務確認此類聲明以反映發佈之後的後續事件或情況或與實際業績相關的情況。

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/或其子公司擁有以下商標:Genmab; Y 形的 Genmab 徽標; Genmab 與 Y 形的 Genmab 徽標相結合; HuMax; duoBody; HexAbody; duoHexBody,Hexelect還有 KYSO。 EPCORE, 令人毛骨悚然地,TEPKINLY 而且它們的設計是艾伯維生物技術有限公司的商標


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 等在臨床前模型中,duobody-CD3xCD20誘導強效的T細胞介導殺死惡性B細胞,併爲皮下給藥提供了機會。 電子生物醫學. 2020; 52:102625. doi: 10.1016/j.ebiom.2019.102625。

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

新聞稿編號:i05
CVR 號 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
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2500 Valby
Denmark

Genmab A/S
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