On November 2, 2023 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, across a variety of treatment settings and hematologic malignancies have been accepted for presentation and publication at the 65thAnnual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held in San Diego, California, and virtually, December 9-12 (Press release, Genmab, NOV 2, 2023, View Source [SID1234636760]). The presentations will include two oral and 11 poster presentations highlighting data from several trials evaluating the safety and efficacy of epcoritamab as a monotherapy or in combination for the treatment of patients with various lymphoma subtypes, across lines of therapy including relapsed/refractory (R/R) and newly diagnosed patients.

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Additionally, results from a phase 1/2 trial evaluating GEN3014 (HexaBody-CD38), an investigational novel human CD38 monoclonal antibody, in patients with R/R multiple myeloma (MM), will be presented.

All abstracts accepted for presentation have been published on the ASH (Free ASH Whitepaper) website.

"The breadth and depth of data accepted for presentation at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting underline our dedication to comprehensive evaluation of our investigational medicines and reinforce our joint commitment with AbbVie to develop epcoritamab as a potential core therapy for B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.

2023 R&D Update and ASH (Free ASH Whitepaper) Data Review
On Tuesday, December 12, at 11:00 AM EST (5:00 PM CET/4:00 PM GMT), Genmab will host its 2023 R&D Update and ASH (Free ASH Whitepaper) 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 (Free ASH Whitepaper) Annual Meeting.

Abstracts accepted for presentation at ASH (Free ASH Whitepaper):

Epcoritamab (DuoBody-CD3xCD20)

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
438 Subcutaneous Epcoritamab Plus Lenalidomide in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma from EPCORE NHL-5. Avivi, I et al. Oral Sunday, December 10,
9:30 – 11:00 AM PT
1655 Epcoritamab SC Monotherapy Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: Results from the EPCORE NHL-1 Dose Expansion Cohort. Linton KM et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
1729 CRS Mitigation Strategies: Preliminary Results from the DLBCL Optimization Arm A Cohort of EPCORE NHL-1. Vose J et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
3053 EPCORE FL-1: Phase 3 Trial of Subcutaneous Epcoritamab With Rituximab and Lenalidomide (R2) vs R2 Alone in Patients With Relapsed or Refractory Follicular Lymphoma. Falchi L et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT
3092 Epcoritamab SC + GemOx Leads to High Complete Metabolic Response Rates in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Ineligible for Autologous Stem Cell Transplant: Updated Results from EPCORE NHL-2. Brody J, et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT

3135 Identification of Optimal Dosing Regimen for Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Li, T et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT
4481 Population Pharmacokinetics of Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Li, T et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
4457 Subcutaneous Epcoritamab + R-mini-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose Anthracycline: Results from the EPCORE NHL-2 Phase 1/2 Trial. Vermaat JS et al. Poster Monday, December 11, 6:00 – 8:00 PM PT

GEN3014 (HexaBody-CD38)

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
4757 GEN3014 (HexaBody-CD38) in Anti-CD38 mAb–Naive Patients with Relapsed/Refractory Multiple Myeloma: Preliminary Results from a Dose-Expansion Cohort of a Phase 1/2 Trial. Grosicki S, et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
Outcomes Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
309 Effectiveness of Chemo-Immunotherapy (CIT) and Novel Therapies in Second or Later Line of Therapy (2L+) for Patients with Relapsed/Refractory (R/R) Aggressive Large B-cell Lymphoma (LBCL). Nastoupil L et al. Oral Saturday, December 9, 4:00 – 5:30 PM PT
1683 Real-World Response Rates Across Lines of Therapy Among Patients With Relapsed/Refractory Follicular Lymphoma. Philips T et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
1733 Efficacy of Subcutaneous Epcoritamab vs Tisa-cel in R/R LBCL CAR T-naive and CAR T-eligible Patients: An Indirect Comparison. Salles G et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
5089 Cost-Effectiveness of Epcoritamab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma After At Least Two Lines of Therapy in The United States. Qu et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
5158 Patterns of Care and Resource Use Among Elderly Relapsed/Refractory Follicular Lymphoma Patients: US Medicare Claims Analysis. Chawla SB, et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
NA Practice Efficiency Associated with Epcoritamab for The Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma from an Institutional Perspective. Lei M et al. Publication N/A
NA Estimating the Number of Relapsed/Refractory Follicular Lymphoma Patients on Therapy in the United States. Johnston K et al. Publication N/A
Discovery Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
NA Assessment of ultra-deep DIA mass spectrometry-based proteomics compared to flow cytometry and RNA-based methods for the discovery and validation of therapeutic targets in immune cells; Wah Au et al. Publication N/A
NA Unbiased Subtyping of AML: Unraveling Genomic and Transcriptomic Features for Precision Medicine and Targeted Therapies using Beat-AML and TCGA Data; Karagoz et al Publication N/A
The safety and efficacy of epcoritamab has not been established for these investigational uses. The safety and efficacy of HexaBody-CD38 has not been established.

About Large B-cell Lymphoma (LBCL)
LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally.1,2 There are several subtypes of LBCL, including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B).

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of NHL worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.1,3 DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.1,4

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow growing) form of NHL that arises from B-lymphocytes.5 FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.6,7 Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.8,9

About Epcoritamab
Epcoritamab (approved as EPKINLY) 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 towards target cell types. EPKINLY is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell mediated killing of CD20+ cells.10

EPKINLY (also known as TEPKINLY in certain countries) has received regulatory approval in various indications and conditions in the U.S., Japan, the European Union, the United Kingdom and Canada. In the U.S., epcoritamab was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a treatment option for diffuse large B-cell lymphoma (DLBCL).

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 three ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494) compared to investigators choice chemotherapy, a phase 3 trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066). Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. 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.