Genmab Announces Positive Regulatory Updates for Epcoritamab
(EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory
Follicular Lymphoma
Media ReleaseCOPENHAGEN, 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™ NHL-1 trial
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 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™ NHL-1 trial, including an
optimized dosing schedule allowing for outpatient administration,
will be presented at the upcoming 65th 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™ NHL-1 TrialEPCORE™
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 EpcoritamabEpcoritamab 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.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™) 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 Twitter.com/Genmab.
Contact: David
Freundel, Senior Director, Global Communications & Corporate
AffairsT: +1 609 430 2481m; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.comThis 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 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. 13CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 231127_MR13 Epcoritamab FL Regulatory Actions
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