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

Rhea-AI Summary

Genmab announced that it will present new and updated results from clinical trials evaluating epcoritamab at the 2024 EHA Congress. Sixteen abstracts will be presented, showcasing the depth of their epcoritamab development program. The data includes safety and efficacy results across various B-cell malignancies, such as relapsed/refractory follicular lymphoma, diffuse large B-cell lymphoma, and Richter’s transformation.

Three oral presentations will highlight key findings: single-agent epcoritamab results in Richter’s Transformation, epcoritamab combined with Pola-R-CHP for first-line treatment in diffuse large B-cell lymphoma, and epcoritamab's impact on relapsed/refractory follicular lymphoma. The presentations will occur in Madrid and virtually from June 13-16, 2024.

Genmab, in collaboration with AbbVie, continues to advance epcoritamab's development as both a monotherapy and combination therapy. The abstracts are available via the EHA Open Access Library.

Positive

• Sixteen abstracts accepted for presentation at a major medical congress, showcasing extensive research.
• Three oral presentations highlighting significant clinical trial results.
• Epcoritamab shows promising safety and efficacy data in various B-cell malignancies.
• Collaboration with AbbVie indicates strong partnership and support for epcoritamab's development.

Negative

• The safety and efficacy of the investigational uses have not been established.
• No detailed financial data or revenue impacts provided in the announcement.
• Potential risks remain regarding regulatory approvals and clinical trial outcomes.

Medical Research Analyst

Clinical Trial Insights: The recent presentations on epcoritamab at the 2024 European Hematology Association (EHA) Congress offer a comprehensive view of its development program. Notably, the data presented covers a wide spectrum of B-cell malignancies including relapsed/refractory follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) and Richter’s transformation (RT). These malignancies are highly heterogeneous and resistant to conventional therapies, making the positive results presented for epcoritamab particularly significant.

Specifically, the use of epcoritamab in combination with existing chemotherapy regimens and other novel therapies is promising. Such combinations could potentially enhance the efficacy of current treatment protocols and offer new hope for patients with limited options. The primary results from the EPCORE CLL-1 trial showing deep responses in RT patients indicate a breakthrough, especially given the aggressive nature of RT.

For retail investors, these findings suggest that Genmab's strategic focus on expanding the use of epcoritamab across different B-cell malignancies may lead to substantial market opportunities. The company's commitment to rigorous clinical trials underscores its potential as a leader in the hematology sector. However, it's important to remain cautious until these results translate into long-term patient benefits and receive broader regulatory approvals.

Financial Analyst

Financial Implications: Genmab's extensive presentation at the EHA Congress has several financial implications. Firstly, the breadth of data indicates a robust pipeline and a strong commitment to innovation in the oncology sector. This is important as it demonstrates the company's ability to continually advance its therapeutic offerings.

From a financial perspective, the ongoing trials and the imminent data readouts are likely to affect Genmab’s stock volatility. Positive clinical outcomes generally lead to a boost in investor confidence and potential stock price appreciation. Moreover, the focus on first-line treatments, such as the combination regimen for DLBCL, could tap into larger patient populations, significantly expanding the market potential for epcoritamab.

However, investors should be aware of the risks associated with clinical trials. Failures or delays in obtaining regulatory approvals can have adverse financial effects. Additionally, competition in the B-cell malignancy space is intense, with several biotech firms pursuing similar therapeutic targets. Investors should monitor updates closely, especially those concerning regulatory milestones and partnerships.

Oncology Doctor

Clinical Significance: The new data on epcoritamab presented at the EHA Congress is particularly noteworthy for the medical community. Epcoritamab is a T-cell engaging bispecific antibody, which is an innovative approach in cancer therapy. The mechanism involves bridging T-cells to cancer cells, facilitating a targeted immune response. This method has shown promise in overcoming some resistance seen in traditional therapies.

The results presented for relapsed/refractory follicular lymphoma and DLBCL are compelling. Particularly, the combination therapies presented in the EPCORE NHL-5 trial offer a novel first-line treatment option, potentially improving patient outcomes significantly. The deep responses observed in RT patients also highlight the potential of epcoritamab in treating aggressive and otherwise intractable forms of cancer.

However, it remains important to assess the long-term safety and efficacy of these treatments. Immune-related side effects and the durability of responses are critical factors that need thorough evaluation. As these trials progress, ongoing vigilance in monitoring adverse effects and patient quality of life will be essential.

• 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)

COPENHAGEN, Denmark--(BUSINESS WIRE)-- 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 malignancies,” 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.

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 may receive other medicines before receiving EPKINLY and you will also be given smaller doses of EPKINLY for the first 2 doses (called “step-up” dosing). Your first full dose of EPKINLY will be given on day 15 of your first cycle of treatment and you should be hospitalized for 24 hours after due to risk of CRS and neurologic problems. 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.

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. Do not drive or use heavy machinery or do other dangerous activities if you have any symptoms that impair consciousness until your symptoms go away.

EPKINLY can cause other serious side effects, including:

• Infections that may lead to death. 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 are common during treatment with EPKINLY and 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.

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. These are not all 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 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.

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™. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240514430927/en/

David Freundel, Senior Director, Product Communications

T: +1 609 430 2481; E: dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

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

Source: Genmab A/S

FAQ

What is the significance of Genmab's presentations at the 2024 EHA Congress?

Genmab's presentations will highlight new and updated results from clinical trials evaluating epcoritamab across various B-cell malignancies, showing the depth of their development program.

Which clinical trials will be highlighted in Genmab's presentations at the EHA Congress?

Highlights include trials for relapsed/refractory follicular lymphoma, first-line treatment for diffuse large B-cell lymphoma, and Richter’s transformation.

When and where will Genmab present the new results for epcoritamab?

The presentations will take place at the European Hematology Association Congress in Madrid and virtually from June 13-16, 2024.

What are the potential applications of epcoritamab based on the presented data?

Epcoritamab is being evaluated for use in various B-cell malignancies, including relapsed/refractory follicular lymphoma, diffuse large B-cell lymphoma, and Richter’s transformation.

How many abstracts related to epcoritamab were accepted for presentation at the EHA Congress?

A total of sixteen abstracts related to epcoritamab were accepted for presentation.