TIDMGEN
Media Release
COPENHAGEN, Denmark; December 9, 2023
-- Data from the pivotal phase 1/2 EPCORE(TM) NHL-1 study showed 82 percent
overall response rate (ORR), 63 percent complete response (CR) and 67
percent minimal residual disease (MRD) negativity in patients with
relapsed/refractory (R/R) follicular lymphoma (FL) treated with
subcutaneous epcoritamab
-- Results presented at the 65th American Society of Hematology (ASH) Annual
Meeting and Exposition include data from an optimized step-up dosing
schedule for FL patients showing meaningful reduction in risk and
severity of cytokine release syndrome (CRS)
-- Follicular lymphoma is the second most common form of non-Hodgkin's
lymphoma, is considered incurable and can be difficult to treat in the
R/R setting
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Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced
new data from the ongoing phase 1/2 EPCORE(TM) NHL-1 clinical trial
investigating epcoritamab (DuoBody(R) CD3xCD20), a T-cell engaging
bispecific antibody administered subcutaneously, demonstrated an
overall response rate (ORR) of 82 percent, a complete response (CR)
rate of 63 percent and minimal residual disease (MRD) negativity
rate of 67 percent in patients with relapsed/refractory (R/R)
follicular lymphoma (FL). The presentation included data from an
optimized step-up dosing schedule for FL patients showing a
reduction in risk and severity of Grade 2+ cytokine release
syndrome (CRS), a common side effect of T-cell engaging cancer
treatments. These results were presented today at the 2023 65(th)
Annual Meeting and Exposition of the American Society of Hematology
(ASH), being held in San Diego, California, December 9-12, 2023
(Abstract #1655
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).
"Despite treatment advances for patients with follicular
lymphoma whose disease has unfortunately progressed, treating
relapsed or refractory follicular lymphoma remains highly
challenging, particularly in the third-line plus setting," said
Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology
department, Paris University, Hôpital Saint-Louis
Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The
patients in this trial represent a historically difficult-to-treat
patient population. The data presented today are especially notable
because they demonstrated high overall and complete response rates
for this investigational follicular lymphoma therapy and a preview
for its potential as an alternative treatment option."
Overall results from the pivotal cohort of 128 adult patients
showed that:
-- At a median follow-up of 17.4 months, the study's primary endpoint ORR
was 82 percent, which exceeded the protocol defined threshold for
efficacy, with a CR rate of 63 percent, and 67 percent MRD negativity.
-- The median time to response was 1.4 months and median time to CR was 1.5
months.
-- Median progression-free survival (PFS) for patients who achieved a CR was
not reached nor was the median duration of response, duration of CR, MRD
negativity and overall survival.
-- An estimated 85 percent and 74 percent of patients who experienced a CR
remained in response at 12 and 18 months, respectively.
Among prespecified subgroups, ORR and CR rates were generally
consistent with the overall patient population. Notably, high-risk
patients who were refractory to both anti-CD20 therapy and an
alkylating agent achieved a 76 percent ORR and 56 percent CR;
patients who were refractory to last prior treatment achieved a 74
percent ORR and 51 percent CR rate; and patients whose disease
progressed within two years of first-line immunochemotherapy
(POD24) achieved an 80 percent ORR and 61 percent CR.
Safety findings were consistent with previous epcoritamab
trials, and epcoritamab was generally well tolerated. Following an
optimized step-up dose regimen for FL patients (n=50) to reduce the
risk and severity of CRS, 40 percent of patients experienced Grade
1 CRS and 8 percent experienced Grade 2 (no Grade 3 or higher CRS
were reported) and no Immune Effector Cell-Associated Neurotoxicity
Syndrome (ICANS) was reported. This data may support outpatient
administration. Additional common treatment-emergent adverse events
(TEAEs) from the pivotal cohort (>20 percent) were
injection-site reaction (57 percent), COVID-19 (40 percent),
fatigue (30 percent), neutropenia (29 percent), diarrhea (27
percent) and pyrexia (25 percent). TEAEs leading to treatment
discontinuation occurred in 19 percent of patients, and Grade 5
TEAEs occurred in 13 patients (10 percent).
"Follicular lymphoma patients who have experienced a relapse
following heavy pre-treatment, or whose disease is not responding
to available therapies, are considered high risk and are in need of
alternative therapeutic options," said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab. "The data presented at ASH
reinforce what we have seen from our epcoritamab research and
believe that this investigational bispecific antibody could
potentially represent an important treatment option for patients
living with relapsed or refractory follicular lymphoma. Along with
our partner AbbVie, we look forward to progressing epcoritamab in
clinical trials and discussing the results with regulatory
authorities and remain committed to developing epcoritamab as a
potential future core therapy for B-cell malignancies."
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 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 Follicular Lymphoma (FL)
FL is typically an indolent (or slow growing) form of
non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes.(i) 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.(i) (,) (ii) (,) (iii) Although FL
is an indolent lymphoma, it is considered incurable with
conventional therapy(iv) (,) (v) and patients who achieve remission
also often experience relapse.(vi)
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.(vii)
Epcoritamab (approved under the brand name EPKINLY(R) in the
U.S. and Japan, and TEPKINLY(R) in the EU) has received regulatory
approval in certain lymphoma indications in several territories.
Use of epcoritamab in FL is not approved in any country, including
the U.S. and 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 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(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
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Contact:
David Freundel, Senior Director, Global Communications &
Corporate Affairs
T: +1 609 430 2481m; E: dafr@genmab.com
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Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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
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changes and developments in technology which may render our
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discussion of these risks, please refer to the risk management
sections in Genmab's most recent financial reports, which are
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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.
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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(R) , TEPKINLY(R) and their designs are
trademarks of AbbVie Biotechnology Ltd.
(i) Lymphoma Research Foundation official website.
https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed June 2023.
(ii) Ma S. Risk factors of follicular lymphoma. Expert Opin Med
Diagn. 2012;6:323--33. doi: 10.1517/17530059.2012.686996.
(iii) Luminari S, Bellei M, Biasoli I, Federico M. Follicular
lymphoma--treatment and prognostic factors. Rev Bras Hematol
Hemoter. 2012;34:54--9. doi: 10.5581/1516-8484.20120015.
(iv) Link BK, 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.
(v) Ren J, et al. 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.
(vi) Lymphoma Research Foundation official website.
https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/.
Accessed November 2023.
(vii) 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. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 231209_MR14 ASH Epcoritamab FL Data
https://ml-eu.globenewswire.com/Resource/Download/a1897e25-31c9-405d-8b3b-44381046a216
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