Company Announcement
- Based on the topline results from the EPCORE™ NHL-1
clinical trial, Genmab and AbbVie will engage
with global regulatory authorities to
discuss next steps
- Data from the clinical trial
will be presented at a future medical
meeting
- Follicular Lymphoma is a common form
of non-Hodgkin’s lymphoma (NHL) and currently has limited treatment
options, particularly in the relapsed/refractory
setting
COPENHAGEN, Denmark;
June 28,
2023 –
Genmab A/S
(Nasdaq:
GMAB) and AbbVie (NYSE:
ABBV) today announced topline
results from the follicular
lymphoma (FL) cohort of the
phase 1/2 EPCORE™ NHL-1 clinical
trial evaluating epcoritamab (DuoBody® CD3xCD20), an
investigational T-cell engaging bispecific antibody administered
subcutaneously. The study cohort includes 128 adult patients with
relapsed/refractory follicular lymphoma (FL) who received at least
two prior lines of systemic therapy. 70.3 percent of patients were
double refractory to an anti-CD20 monoclonal antibody and an
alkylating agent. Based on the topline results, the companies will
engage with global regulatory authorities to determine next steps.
Epcoritamab is being co-developed by Genmab and AbbVie as part of
the companies' oncology collaboration.
The topline results from this cohort showed an overall response
rate (ORR) of 82 percent as confirmed by an independent review
committee (IRC), which exceeded the protocol prespecified threshold
for efficacy. The observed median duration of response (DOR) was
not reached. No new safety signals were observed with epcoritamab
in this study at the time of analysis. The most common
treatment-emergent adverse event was cytokine release syndrome
(CRS) with 66.4 percent (1.6 percent grade >2). Aligned with the
U.S. Food and Drug Administration’s (FDA) Project Optimus, the
optimization part of the trial is continuing to evaluate
alternative step-up dosing regimens to mitigate the risk of CRS;
preliminary data on the initial patients enrolled indicate a
clinically meaningful improvement in CRS rate. The results from
this cohort, along with the results from the optimization part of
the trial, will be submitted for presentation at an upcoming
medical congress.
“These topline results are encouraging for relapsed or
refractory follicular lymphoma patients who are in need of new
therapeutic options,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. “With our partner AbbVie, we are
committed to evaluating epcoritamab as a potential core therapy
across B-cell malignancies. We look forward to sharing the full
results from this study cohort at an upcoming medical congress and
discussing the results with global regulatory authorities.”
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 2 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 phase 2
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
further minimize grade 2 CRS and mitigate the risk of 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 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.ii,iii Although FL is
an indolent lymphoma, it is considered incurable with conventional
therapy.iv,v
About Epcoritamab Epcoritamab is an
investigational 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.vi
Epcoritamab-bysp (EPKINLYTM) was recently approved in the United
States and is indicated for the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not
otherwise specified (NOS), including DLBCL arising from indolent
lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more
lines of systemic therapy. This indication is approved under
accelerated approval based on response rate and durability of
response. Continued approval for this indication is contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In October 2022, a Marketing Authorization Application was
submitted for epcoritamab for the treatment of patients with R/R
DLBCL after two or more lines of systemic therapy, which was
validated by the European Medicines Agency. Additionally, in
December 2022, a Japan new drug application was submitted to the
Ministry of Health, Labor and Welfare of Japan for epcoritamab for
the treatment of patients with R/R LBCL after two or more lines of
systemic therapy. Epcoritamab is not approved in the European Union
and Japan. The companies will share commercial responsibilities in
the U.S. and Japan, with AbbVie responsible for further global
commercialization. AbbVie will continue to pursue regulatory
submissions for epcoritamab across international markets excluding
the U.S. and Japan throughout the year.
Genmab and AbbVie are continuing to evaluate the use of
epcoritamab as a monotherapy, and in combination, across lines of
therapy in a range of hematologic malignancies. This includes an
ongoing phase 3, open-label, randomized trial evaluating
epcoritamab as a monotherapy in patients with R/R DLBCL (NCT:
04628494), an ongoing phase 3, open-label, randomized trial
evaluating epcoritamab in combination in adult participants with
newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label
clinical trial evaluating epcoritamab in combination in patients
with R/R follicular lymphoma (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.
EPKINLY™ (epcoritamab-bysp)
U.S. IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side
effects, including:
- Cytokine Release Syndrome (CRS). CRS is
common during treatment with EPKINLY and can be serious or
life-threatening. Tell your healthcare provider or get medical help
right away if you develop symptoms of CRS, including fever of
100.4°F (38°C) or higher, dizziness or lightheadedness, trouble
breathing, chills, fast heartbeat, feeling anxious, headache,
confusion, shaking (tremors), or problems with balance and
movement, such as trouble walking.Due to the risk of CRS,
you will receive EPKINLY on a "step-up" dosing
schedule. The step-up dosing schedule is when you
receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of
your first cycle of treatment (cycle 1). You will receive your
first full dose of EPKINLY on day 15 of cycle 1. If your dose of
EPKINLY is delayed for any reason, you may need to repeat the
step-up dosing schedule. Before each dose in cycle 1, you will
receive medicines to help reduce your risk of CRS. Your healthcare
provider will decide if you need to receive medicine to help reduce
your risk of CRS with future cycles.
- Neurologic problems. EPKINLY can cause
serious neurologic problems that can be life-threatening and lead
to death. Neurologic problems may happen days or weeks after you
receive EPKINLY. Your healthcare provider may refer you to a
healthcare provider who specializes in neurologic problems. Tell
your healthcare provider right away if you develop any symptoms of
neurologic problems, including trouble speaking or writing,
confusion and disorientation, drowsiness, tiredness or lack of
energy, muscle weakness, shaking (tremors), seizures, or memory
loss.
Due to the risk of CRS and neurologic problems,
you should be hospitalized for 24 hours after receiving your first
full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider
will monitor you for symptoms of CRS and neurologic problems during
treatment with EPKINLY, as well as other side effects, and treat
you if needed. Your healthcare provider may temporarily stop or
completely stop your treatment with EPKINLY if you develop CRS,
neurologic problems, or any other side effects that are severe.
Do not drive or use heavy or potentially
dangerous machinery if you develop dizziness, confusion, tremors,
drowsiness, or any other symptoms that impair consciousness until
your symptoms go away. These may be symptoms of CRS or neurologic
problems.
EPKINLY can also cause other serious side effects,
including:
- Infections. EPKINLY can cause serious
infections that may lead to death. Your healthcare provider will
check you for symptoms of infection before and during treatment.
Tell your healthcare provider right away if you develop any
symptoms of infection during treatment, including fever of 100.4°F
(38°C) or higher, cough, chest pain, tiredness, shortness of
breath, painful rash, sore throat, pain during urination, or
feeling weak or generally unwell.
- Low blood cell counts. Low blood cell
counts are common during treatment with EPKINLY and can be serious
or severe. Your healthcare provider will check your blood cell
counts during treatment. EPKINLY may cause low blood cell counts,
including low white blood cell counts
(neutropenia), which can increase your risk for
infection; low red blood cell counts
(anemia), which can cause tiredness and shortness of
breath; and low platelet counts
(thrombocytopenia), which can cause bruising or bleeding
problems.
Your healthcare provider may temporarily stop or completely stop
treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare
provider about all of your medical conditions, including if
you:
- have an infection.
- are pregnant or plan to become pregnant. EPKINLY may harm your
unborn baby. Females who are able to become
pregnant: Your healthcare provider should do a
pregnancy test before you start treatment with EPKINLY. You should
use effective birth control (contraception) during treatment and
for 4 months after your last dose of EPKINLY. Tell your healthcare
provider if you become pregnant or think that you may be pregnant
during treatment with EPKINLY.
- are breastfeeding or plan to breastfeed. It is not known if
EPKINLY passes into your breast milk. Do not breastfeed during
treatment with EPKINLY and for 4 months after your last dose of
EPKINLY.
Tell your healthcare provider about all of the medicines
you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
The most common side effects of
EPKINLY include CRS, tiredness, muscle and bone pain,
injection site reactions, fever, stomach-area (abdominal) pain,
nausea, and diarrhea.
These are not all the possible side effects of EPKINLY. Call
your doctor for medical advice about side effects.
You are encouraged to report side effects to the FDA at (800)
FDA-1088 or www.fda.gov/medwatch or to Genmab US,
Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see the Full Prescribing Information
and Medication Guide, including Important
Warnings.
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: Marisol
Peron, Senior Vice President, Communications and Corporate
AffairsT: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.com This Company Announcement 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
Company Announcement 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®; DuoBody in combination with the
DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody
logo®; DuoHexaBody® and HexElect®. EPKINLY™ is owned by 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 Engelberts 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
Company Announcement no. 33 CVR no. 2102 3884 LEI Code
529900MTJPDPE4MHJ122
Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark
- 280623-ca33-epcoritamab-fl-topline
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