GMAB Genmab AS

 

Genmab A/S (Nasdaq: GMAB):

• More than 20 abstracts, including four oral presentations, with new clinical data across lines of therapy and subgroups of non-Hodgkin’s lymphoma (NHL) patients
• New and updated data from EPCORE® clinical trial program reinforce the potential of epcoritamab as a monotherapy and in combination to treat multiple B-cell malignancies across lines of therapy

Genmab A/S (Nasdaq: GMAB) announced today more than 20 abstracts evaluating epcoritamab-bysp (EPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL) subtypes, will be presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the San Diego Convention Center in San Diego, California, and online, December 7-10.

The breadth of the epcoritamab development program will be featured at this year's ASH in four oral presentations. Three of the oral presentations will highlight data evaluating fixed-duration subcutaneous epcoritamab in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), large B-cell lymphoma (LBCL), and relapsed/refractory (R/R) follicular lymphoma (FL). The fourth oral presentation will feature the results of a study evaluating epcoritamab monotherapy in patients with R/R chronic lymphocytic leukemia (CLL). Additionally, three-year efficacy and safety data for subcutaneous epcoritamab in patients with R/R DLBCL from the EPCORE® NHL-1 trial will be presented.

“The data evaluating epcoritamab being presented at this year’s ASH highlight the encouraging clinical results we have seen across epcoritamab clinical trials and demonstrate its potential as a core therapy for B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “This has been a pivotal year for epcoritamab, and alongside our partner AbbVie, we are committed to progressing the comprehensive epcoritamab development program with the goal of potentially providing additional therapeutic options to patients in need of treatments.”

All abstracts accepted for presentation have been published on the ASH Website.

2024 R&D Update and ASH Data Review

On Wednesday, December 11, at 11:00 AM EST (5:00 PM CET/4:00 PM GMT), Genmab will host its 2024 R&D Update and ASH Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH Annual Meeting.

Abstracts accepted for presentation at ASH include:

Oral Presentations

Abstract Number

Abstract Title

Type of Presentation

Date/Time of Presentation

342

Fixed-Duration Epcoritamab + R2 Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: 2-Year Follow-Up from Arm 2 of the EPCORE NHL-2 Trial

Oral

Saturday, December 7, 4:00 - 5:30 PM PT

 

 

 

581

Fixed-Duration Epcoritamab + R-CHOP Induces High Complete Response Rates in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma with High-Risk Features: Long-Term Results from the EPCORE NHL-2 Trial

Oral

Sunday, December 8, 12:00 - 1:30 PM PT

867

EPCORE DLBCL-3 First Disclosure: Fixed-Duration Epcoritamab Monotherapy in Older (≥75 y), Anthracycline-Ineligible Patients with Previously Untreated Large B-Cell Lymphoma

Oral

Monday, December 9, 2:45 - 4:15 PM PT

883

Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of EPCORE CLL-1

Oral

Monday, December 9, 2:45 - 4:15 PM PT

Poster Presentations

Abstract Number

Abstract Title

Type of Presentation

Date/Time of Presentation

1414

Exposure-Response Analyses Supporting Optimal Epcoritamab 48 mg Full Dose and Dosing Schedule in Relapsed or Refractory Follicular Lymphoma

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

1622

Epcoritamab with R-CHOP Overcomes Poor Risk Features of High Metabolic Tumor Volume in High-Risk Large B-Cell Lymphoma

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

1627

Fixed-Duration Epcoritamab in Combination with Bendamustine + Rituximab for First-Line Treatment of Follicular Lymphoma: Initial Results from EPCORE NHL-2 Arm 3

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

1703

Trends in All-Cause Mortality Rates in Patients with Follicular Lymphoma in the US before and during the COVID-19 Pandemic: A Retrospective Observational Study

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

1734

Immune Biomarkers of Mechanism of Action of Epcoritamab (Epcor) Plus Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) in Frontline DLBCL

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

1737

Efficacy and Safety of Epcoritamab Monotherapy in Patients with Relapsed or Refractory LBCL Not Previously Exposed to CAR T: Subanalysis of the EPCORE NHL-1 Trial

Poster

Saturday December 7, 5:30 - 7:30 PM PT

2349

Indirect Comparisons of the Efficacy of Epcoritamab Vs Glofitamab in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

2998

Epcoritamab Induces in vitro-derived Terminally Differentiated Exhausted T Cells to Kill B Cells

Poster

Saturday, December 7, 5:30 - 7:30 PM PT

3106

Fixed-Duration Epcoritamab + R-Mini-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose R-CHOP: Updated Results from Arm 8 of the EPCORE NHL-2 Trial

Poster

Sunday, December 8, 6:00 - 8:00 PM PT

3110

Fixed-Duration Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results from Arm 1 of the Epcore NHL-5 Trial

Poster

Sunday, December 8, 6:00 - 8:00 PM PT

3115

Prior Bendamustine (Benda) Exposure Did Not Impact Clinical Outcomes and Decreased CD4+ but Not CD8+ T-Cells in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Treated with the Bispecific Antibody Epcoritamab (Epcor)

Poster

Sunday, December 8, 6:00 - 8:00 PM PT

3231

T cells from CLL patients on venetoclax mount potent cytotoxic responses in combination with epcoritamab, a CD20/CD3 bispecific antibody.

Poster

Sunday, December 8, 6:00 - 8:00 PM PT

3723

Patient Characteristics and Treatment Patterns for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) By CAR T Eligibility and Treatment Status in France, Germany, Italy, Spain, the UK, and Japan

Poster

Sunday, December 8, 6:00 - 8:00 PM PT

4480

3-Year Update from the EPCORE NHL-1 Trial: Epcoritamab Leads to Deep and Durable Responses in Relapsed or Refractory Large B-Cell Lymphoma

Poster

Monday, December 9, 6:00 - 8:00 PM PT

4491

Three-Factor Prediction Model for Grade 2+Cytokine Release Syndrome in Large B-Cell Lymphoma Patients Receiving Epcoritamab Monotherapy

Poster

Monday, December 9, 6:00 - 8:00 PM PT

5124

Epcoritamab for Relapsed/ Refractory B cell Lymphoma – the Israeli Real-World Experience

Poster

Monday, December 9, 6:00 - 8:00 PM PT

E-publications

Abstract Number

Abstract Title

Type of Presentation

Date/Time of Presentation

7614

Cost-Effectiveness of Epcoritamab Versus Glofitamab in Relapsed or Refractory Large B-Cell Lymphoma after at Least Two Lines of Therapy in the United States

E-publication

N/A

7617

A Canadian Cost-Utility Analysis of Epcoritamab Versus Current Therapies in Third-Line or Later Large B-Cell Lymphoma

E-publication

N/A

7757

Epcoritamab plus Gemcitabine and Oxaliplatin versus Glofitamab or Rituximab plus Gemcitabine and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis

E-publication

N/A

7760

Epcoritamab plus Gemcitabine and Oxaliplatin versus Rituximab, Gemcitabine, and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis

E-publication

N/A

7802

Matching-Adjusted Indirect Treatment Comparison of Epcoritamab versus Zanubrutinib Plus Obinutuzumab in Relapsed or Refractory Follicular Lymphoma

E-publication

N/A

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

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 (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. 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.

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 (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

EPKINLY® (epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION

Important Warnings—EPKINLY can cause serious side effects, including:

• Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
• Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.

People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

• Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
• Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.

In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

About 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 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. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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 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™.

_______________________________ 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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David Freundel, Senior Director, Global Communications & Corporate Affairs T: +1 609 613 0504; E: dafr@genmab.com

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