On May 23, 2024 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024 (Press release, Genmab, MAY 23, 2024, View Source [SID1234643596]).

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"The data being presented this year at ASCO (Free ASCO Whitepaper) demonstrate Genmab’s significant progress towards our mission to develop novel antibody therapies with the goal of improving the lives of people impacted by cancer," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.

Presentations will include data from multiple clinical trials evaluating the efficacy and safety of epcoritamab in a variety of treatment settings and patient populations, including a rapid oral presentation evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with previously untreated follicular lymphoma (FL) and a second rapid oral presentation showcasing results from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory (R/R) FL.

Data from the Phase 2 innovaTV 207 trial, evaluating tisotumab vedotin in pretreated patients with relapsed/metastatic head and neck squamous cell carcinoma will be presented during a rapid oral session. Additionally, results from the Phase 3 innovaTV 301 trial evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy will be presented.

Finally, data from the Phase 2 clinical trial evaluating acasunlimab as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic non-small cell lung cancer (mNSCLC) will be presented for the first time during a poster presentation.

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

Virtual mid- to late-stage pipeline update at ASCO (Free ASCO Whitepaper) 2024
On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO (Free ASCO Whitepaper) from its mid- to late-stage pipeline. 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 ASCO (Free ASCO Whitepaper) Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed online via the ASCO (Free ASCO Whitepaper) Meeting Library.

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

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7014 Epcoritamab with rituximab + lenalidomide (R2) in previously untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance in FL: EPCORE NHL 2 arms 6 and 7 Rapid Oral June 2, 4:30-6:00 PM CDT
7015 EPCORE NHL 1 follicular lymphoma (FL) cycle (C) 1 optimization (OPT) cohort: Expanding the clinical utility of epcoritamab in relapsed or refractory (R/R) FL Rapid Oral June 2,
4:30-6:00 PM CDT
7029 Subcutaneous Epcoritamab (SC epcor) administered outpatient (outpt) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL): Results from Phase 2 EPCORE NHL-6 Poster June 3, 9:00 AM-12:00 PM CDT
7032 Epcoritamab + R-DHAX/C in transplant-eligible patients (pts) with high-risk relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Poster June 3, 9:00 AM-12:00 PM CDT
7037 Subcutaneous epcoritamab + GemOx in patients with relapsed or refractory DLBCL: Updated results from EPCORE NHL-2 Poster June 3, 9:00 AM-12:00 PM CDT
7039 Extended follow-up results beyond 2.5 years from the pivotal NHL-1 EPCORE trial: Subcutaneous epcoritamab monotherapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) Poster June 3, 9:00 AM-12:00 PM CDT

TPS7084 EPCORE FL-2: Phase 3 trial of epcoritamab with rituximab and lenalidomide (R2) vs chemoimmunotherapy or R2 in previously untreated follicular lymphoma Poster June 3, 9:00 AM-12:00 PM CDT
Tisotumab Vedotin:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
6012 Tisotumab vedotin in head and neck squamous cell carcinoma: updated analysis from innovaTV 207 Part C Rapid Oral June 3, 8:00-9:30 AM CDT
5531 Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301 Poster June 3, 9:00 AM-12:00 PM CDT
Acasunlimab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
2533 Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): initial results of a randomized, open-label, Phase 2 trial Poster June 1, 9:00 AM-12:00 PM CDT
About Epcoritamab
Epcoritamab-bysp 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. 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 is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration.

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.

About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. Tisotumab vedotin is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis.

Tisotumab vedotin has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU.

About Acasunlimab (GEN1046/BNT311)
Acasunlimab (GEN1046/BNT311) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab’s proprietary DuoBody technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.
Acasunlimab is being developed in collaboration with BioNTech SE under a license and collaboration agreement and is currently in Phase 2 of development.

Please visit www.clinicaltrials.gov for more information about Genmab’s clinical trials.