GEN Genuit Group Plc

 
TIDMGEN 
 

Media Release

COPENHAGEN, Denmark; November 27, 2023

   -- U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy 
      Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or 
      refractory (R/R) follicular lymphoma (FL) after two or more lines of 
      systemic therapy 
 
   -- European Medicines Agency (EMA) validates regulatory application for 
      epcoritamab for the same indication 
 
   -- The regulatory actions are supported by data from the phase 1/2 
      EPCORE(TM) NHL-1 trial 

https://www.globenewswire.com/Tracker?data=bJzRITyE4CiOAoJYG3T140XLlgpzxwLFSHrdUcD3xRQf0Y94V-E92NDAwbsMNU-FsU3mTJcFJfgV_pGm7QLY5A== Genmab A/S (Nasdaq: GMAB) today announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. BTD may expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.

Additionally, the EMA has validated a Type II variation application for epcoritamab for the same indication. EMA validation confirms that the application is complete and commences the scientific review process by the EMA's Committee for Medicinal Products for Human Use (CHMP). If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.

"Despite recent treatment advances in relapsed or refractory follicular lymphoma, a need still exists for more treatment options," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are encouraged by these recent decisions from the regulatory authorities, and we are hopeful that this may help accelerate the process of delivering epcoritamab to people living with this disease. We're committed to working with AbbVie to explore the full potential of epcoritamab as a potential core therapy for patients with B-cell malignancies."

These regulatory actions were supported by previously announced https://www.globenewswire.com/Tracker?data=SPD5PRVoJEy6GlOWZNHIa9SjrW4o_Yovd-HbslmDaVkDLii4U1xUXQlKDMmiJqy-tl2tY8dDSPTJxCpZHvLgnGNkSqP1pIzeuoGWUAae2GYZHQqqio3qUXLUOgz1l3-Cx4TgcJFnwLxnYS7_T56O65LkMdhevBgsxGl9ZSiADNGCsiK5lsGGeP1F4svLZavq-6zmyeE2349Ib9DyZsaE8w== results from the phase 1/2 EPCORE NHL-1 clinical trial, an open-label, multi-center safety and preliminary efficacy study evaluating subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including FL. Updated results from the R/R FL cohort of the EPCORE(TM) NHL-1 trial, including an optimized dosing schedule allowing for outpatient administration, will be presented at the upcoming 65(th) Annual Meeting and Exposition of the American Society of Hematology (ASH) taking place December 9-12 in San Diego, California.

About Follicular Lymphoma (FL)

FL is typically an indolent, or slow-growing, form of non-Hodgkin's lymphoma (NHL) that arises from B-cell lymphocytes.(i) FL is the second most common form of NHL overall, accounting for 20 to 30 percent of all NHL cases, and representing 10 to 20 percent of all lymphomas in the Western world.(ii) (,) (iii) Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.(iv) (,) (v)

About the Phase 1/2 EPCORE(TM) NHL-1 Trial

EPCORE(TM) NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a phase 1 first-in-human, dose escalation part; a phase 2a expansion part; and a phase 2a dose optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (B-NHL), including FL. In the phase 2a expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The dose optimization part evaluates the potential for alternative step-up dosing regimens to help further minimize Grade 2 cytokine release syndrome (CRS) and mitigate Grade >=3 CRS. The application for BTD included additional data from this cohort of patients. The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints.

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody(R) 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.(vi)

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. Use of epcoritamab in FL is not approved in the U.S. or in the EU. 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 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 investigator's 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.

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 more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted 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(TM)) 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 https://www.globenewswire.com/Tracker?data=bJzRITyE4CiOAoJYG3T14zuPMVW-hypzTn06YYC4hvxwS4QJp8ayc5rRIcifGPuUj-9EaLmfch_siGdKqULkdw== and follow us on Twitter.com/Genmab https://www.globenewswire.com/Tracker?data=vJPVlSvXKfuZi6TM_tZGMjbhgkP6c3PYdbaFuNsZSPx0-NlbZWA2fQM430zKycwNku1vQWsw6Ti_pXPl2_yIYm9EsswN9P6nwyun-pkK6EA= .

Contact:

David Freundel, Senior Director, Global Communications & Corporate Affairs

T: +1 609 430 2481m; E: dafr@genmab.com https://www.globenewswire.com/Tracker?data=HSgTkMdac0dS5zEwTBDZsqdvveGFByrj_BXpVDr1dJAV6BNMhMBdg8yeVFogyDRFD682mYJwULOHaIk2W3WS8w==

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com https://www.globenewswire.com/Tracker?data=gY61f5tXZgEa853HY8OuQCLs1SFzPqnN8MFuz2MjdZ974e3ukTWiGPH4LHP7RqdldOCcDQo33rKBznpwLUUtKw==

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

https://www.globenewswire.com/Tracker?data=25ollujtpSxg87bgLQGCZyhIVOYu3x6eo5ZZ44gdOz1kLfEX-VrpuU3oGHIKvRv1AvMu_YMGPgDRPvz6nMYuAw== 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 https://www.globenewswire.com/Tracker?data=25ollujtpSxg87bgLQGCZ49L5US2FKxJ1pvwlfOogfucdQjr-QIq9_w24_i-BBcWrR_5Vf9mGVVf0wgC_7_r7aBz9_2PVAbyrsL7fn2uI00= 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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; HexaBody(R) ; DuoHexaBody(R) , HexElect(R) and KYSO(TM). EPCORE(TM), EPKINLY(TM), TEPKINLY(R) and their designs are trademarks of AbbVie Biotechnology Ltd.

(i) What is Lymphoma? Lymphoma Research Foundation. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed September 11, 2023.

(ii) Ma S. Risk factors of follicular lymphoma. Expert Opin Med Diagn. 2012;6:323-333. DOI: 10.1517/17530059.2012.686996.

(iii) Luminari S, Bellei M, Biasoli I, et al. Follicular lymphoma--treatment and prognostic factors. Rev Bras Hematol Hemoter. 2012;34:54-59. DOI: 10.5581/1516-8484.20120015.

(iv) Link BK, Day BM, Zhou X, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in the United States: Data From the Observational National LymphoCare Study. Br J Haematol. 2019;184(4):660-663. DOI: 10.1111/bjh.15149.

(v) Ren J, Asche CV, Shou Y, Galaznik A. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the USA. J Comp Eff Res. 2019;8(6):393-402. DOI: 10.2217/cer-2018-0094.

(vi) 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.

Media Release no. 13

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

   -- 231127_MR13 Epcoritamab FL Regulatory Actions 
      https://ml-eu.globenewswire.com/Resource/Download/ce02c7b7-be5d-4af2-a591-39c84fe9dd3d 
 
 
 

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