GE9 Genmab AS

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

Media ReleaseCOPENHAGEN, Denmark; May 14, 2024

• 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)

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.

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.

“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.”

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

Abstracts accepted for presentation at EHA:

Clinical Research

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

Outcomes Research

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

Pharmacokinetic/Translational Research

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

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

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.

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.

About GenmabGenmab 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.

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.

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

Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis 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 www.genmab.com 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.

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®, HexElect® and KYSO™. EPCORE™, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.

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.

 

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