U.S. FDA Accepts for Priority Review the Supplemental Biologics
License Application for Epcoritamab (EPKINLY®) for
Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
Media Release
COPENHAGEN, Denmark; February 27, 2024
- FDA grants Priority Review with target action date of
June 28, 2024
- Application based on results from Phase 1/2 EPCORE™
NHL-1 trial demonstrating clinically meaningful treatment responses
in difficult-to-treat patients with relapsed or refractory (R/R)
follicular lymphoma (FL)
- sBLA submission demonstrates Genmab’s commitment to
exploring potential utility of epcoritamab across B-cell
malignancies
Genmab A/S (Nasdaq: GMAB)
and AbbVie (NYSE: ABBV) today
announced the U.S. Food and Drug Administration (FDA) granted
Priority Review for the supplemental Biologics License Application
(sBLA) for epcoritamab-bysp, a T-cell engaging bispecific antibody
administered subcutaneously, for the treatment of adult patients
with relapsed or refractory (R/R) follicular lymphoma (FL) after
two or more lines of systemic therapy.
The FDA grants Priority Review to investigational therapies
that, if approved, may offer significant improvements in the safety
or effectiveness of the treatment, diagnosis, or prevention of
serious conditions when compared to standard applications. This
designation shortens the review period to six months compared to 10
months for Standard Review.i The FDA has assigned a Prescription
Drug User Fee Act (PDUFA) target action date of June 28, 2024.
“While treatment for patients with relapsed and refractory
follicular lymphoma has progressed, there remains an urgent need
for new treatment options, particularly for patients who are
considered difficult to treat due to relapse following standard
therapies and other poor prognostic factors,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. “The acceptance
of the epcoritamab application for Priority Review marks an
important milestone toward potentially providing a new treatment
option to patients affected by R/R follicular lymphoma. Together
with AbbVie, we look forward to working with the FDA during the
review and remain committed to developing epcoritamab as a
potential future core therapy for B-cell malignancies.”
The sBLA is based on results from the Phase 1/2 EPCORE™ NHL-1
clinical trial, which demonstrated high overall and complete
responses in patients with R/R FL treated with epcoritamab. Data
from the FL cohort of the trial were presented at the Annual
Meeting and Exposition of the American Society of Hematology (ASH)
in December 2023. The FDA previously granted Breakthrough Therapy
Designation (BTD) to epcoritamab for the treatment of adult
patients with R/R FL after two or more lines of systemic therapy.
The application for BTD included additional data from the dose
optimization part of EPCORE NHL-1.
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.
About the Phase 1/2 EPCORE™ NHL-1 TrialEPCORE™
NHL-1 is an open-label, multi-center safety and preliminary
efficacy trial of epcoritamab that consists of three parts: a dose
escalation part; an expansion part; and an 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 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 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 primary endpoint of the expansion part was ORR as assessed by
an IRC. Secondary efficacy endpoints included duration of response,
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. The primary endpoint of the
optimization part was the rate of ≥ Grade 2 CRS events and all
grade CRS events from first dose of epcoritamab through 7 days
following administration of the second full dose of
epcoritamab.
About Follicular Lymphoma (FL)FL is
typically an indolent (or slow-growing) form of non-Hodgkin’s
lymphoma (NHL) that arises from B-lymphocytes.ii 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.iii,iv Although FL is an
indolent lymphoma, it is considered incurable with conventional
therapy and patients who achieve remission also often experience
relapse.v,vi,vii Additionally, with each relapse the
remission and time to next treatment is shorterviii, adding
increased cost to the health system and negatively impacting the
patient's quality of life.ix
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.x
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 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 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.
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 U.S. Food and Drug Administration official website.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
Accessed February 2024.ii Lymphoma Research Foundation official
website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed
February 2024.iii Ma S. Risk factors of follicular lymphoma. Expert
Opin Med Diagn. 2012;6:3232333. doi:
10.1517/17530059.2012.686996.iv Luminari S, Bellei M, Biasoli I,
Federico M. Follicular lymphoma—treatment and prognostic factors.
Rev Bras Hematol Hemoter. 2012;34:54-59. doi:
10.5581/1516-8484.20120015.v Link BK, Day BM, Zhou Z, 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.vi 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.vii Lymphoma Research
Foundation official website.
https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/.
Accessed February 2024.viii Rivas‐Delgado, A., Magnano, L.,
Moreno‐Velázquez, et al. Response duration and survival shorten
after each relapse in patients with follicular lymphoma treated in
the rituximab era. Br J Haematol. 2018;184(5):753-759.
doi:10.1111/bjh.15708ix Kuruvilla J, Ewara EM, Elia-Pacitti J, et
al. Estimating the Burden of Illness of Relapsed Follicular
Lymphoma and Marginal Zone Lymphoma in Ontario, Canada. Curr
Oncol. 2023;30(5):4663-4676. doi:10.3390/curroncol30050352x
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. 05CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
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