- Subcutaneous EPKINLY™ (epcoritamab) is the
first and only bispecific antibody approved in Japan to treat adult
patients with certain types of relapsed/refractory (R/R) large
B-cell lymphoma (LBCL) after two or more lines of systemic
therapy
- Approval based on results of EPCORE™ NHL-3 and
EPCORE™ NHL-1 clinical trials, evaluating EPKINLY
in patients with certain types of R/R LBCL
- LBCL is a common form of non-Hodgkin’s lymphoma (NHL) and
currently has limited treatment options, particularly in the R/R
setting
Genmab A/S (Nasdaq: GMAB) announced today that the Japan
Ministry of Health, Labour and Welfare has approved EPKINLY™
(epcoritamab) as the first and only T-cell engaging bispecific
antibody treatment in Japan of adult patients with certain types of
relapsed or refractory large B-cell lymphoma (LBCL), including
diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma
(HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and
follicular lymphoma grade 3B (FL3B), after two or more lines of
systemic therapy. Epcoritamab is being co-developed by Genmab and
AbbVie as part of the companies' oncology collaboration.
“Despite recent advances in the treatment of LBCL, the prognosis
for patients with relapsed/refractory LBCL remains generally poor,
and there is a need for additional treatment options for patients
whose condition has worsened after multiple lines of treatment,”
said Koji Izutsu, MD, PhD, principal investigator of the phase 1/2
EPCORE NHL-3 trial in Japan and Head of the Hematology Department,
National Cancer Center Hospital. “In the EPCORE NHL-3 trial,
subcutaneous epcoritamab monotherapy demonstrated responses in a
considerable number of patients with relapsed/refractory DLBCL,
indicating that this approval is of great significance.”
The approval of EPKINLY in Japan is based on the results from
two open-label, multi-center studies designed to evaluate the
safety and preliminary efficacy of EPKINLY monotherapy in patients
with R/R LBCL. In the phase 1/2 EPCORE NHL-1 trial, 157 patients
with relapsed or refractory LBCL demonstrated an overall response
rate (ORR) of 63 percent ([95 percent confidence interval (CI):
55.0-70.6]) and a complete response (CR) rate of 39 percent (data
cutoff: January 31, 2022). Of 157 patients treated with EPKINLY,
130 (82.8 percent) experienced treatment related side effects. The
most common side effects (>15 percent) included cytokine release
syndrome (49.7 percent), injection site reactions (19.7 percent),
and neutropenia (17.8 percent).
In the phase 1/2 EPCORE NHL-3 trial, 36 patients with relapsed
or refractory DLBCL after two or more lines of treatment
demonstrated similar results with an ORR of 56 percent ([95 percent
CI: 38.1-72.1]) and a CR rate of 44 percent (data cutoff: January
31, 2022). Of 36 patients treated with EPKINLY, 36 (100 percent)
experienced treatment related side effects. The most common side
effects (>15 percent) included cytokine release syndrome (83.3
percent), injection site reactions (58.3 percent), neutropenia
(30.6 percent), lymphopenia (19.4 percent), decreased appetite
(19.4 percent), thrombocytopenia (19.4 percent), and rash (19.4
percent).
“This approval marks an important milestone for patients in
Japan with relapsed/refractory large B-cell lymphoma who are in
need of alternative therapeutic options and who may now have access
to EPKINLY, the first approved T-cell engaging bispecific
antibody,” said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab. “We are working closely with AbbVie to deliver EPKINLY
to patients in Japan as quickly as possible and we remain committed
to continue evaluating epcoritamab as a potential core therapy
across B-cell malignancies.”
About the EPCORE™ NHL-3 Trial EPCORE™ NHL-3 is an
open-label, multi-center safety and preliminary efficacy trial of
epcoritamab including a phase 1 first-in-human, dose escalation
part; and a phase 2 expansion part. The trial was designed to
evaluate subcutaneous epcoritamab in Japanese patients with
relapsed, progressive or refractory mature B-NHL, including DLBCL.
In the phase 2 expansion part, additional patients are treated with
epcoritamab to further explore the safety and efficacy of
epcoritamab in patients with R/R DLBCL and R/R FL who had limited
therapeutic options.
In the study, 56 percent of the patients had primary refractory
disease and 81 percent of patients were refractory to their last
therapy. The median number of prior therapies was three (range: 2
to 8), with 44 percent of patients receiving two prior therapies,
25 percent receiving three prior therapies, and 31 percent
receiving four or more prior therapies. Nineteen percent had prior
autologous stem cell transplantation (ASCT), no one had prior
chimeric antigen receptor (CAR) T-cell therapy.
About the EPCORE™ NHL-1 Trial EPCORE™ NHL-1 is an
open-label, multi-center safety and preliminary efficacy trial of
epcoritamab that includes a phase 1 first-in-human, dose escalation
part; a phase 2a expansion part; and a dose optimization part. The
trial was designed to evaluate subcutaneous epcoritamab in patients
with relapsed, progressive or refractory CD20+ mature B-cell NHL,
including large B-cell lymphoma (LBCL) and DLBCL.iii Data from the
dose escalation part of the study, which determined the recommended
phase 2 dose, were published in September 2021.iv In the phase 2
expansion part, additional patients were treated with epcoritamab
to further explore the safety and efficacy of epcoritamab in three
cohorts of patients with different types of relapsed/refractory
B-cell NHLs who had limited therapeutic options.iii
The primary endpoint of the phase 2 expansion part was overall
response rate as assessed by an independent review committee.
Secondary efficacy endpoints included duration of response,
complete response rate, progression-free survival, overall
survival, time to response, time to next therapy, and rate of
minimal residual disease negativity.
About Large B-cell Lymphoma (LBCL) LBCL is a type of
non-Hodgkin’s lymphoma (NHL), a cancer that develops in the
lymphatic system, and includes several disease types such as DLBCL,
HGBCL, and PMBCL, which are classified as fast-growing, aggressive
lymphomas. The total number of patients with NHL, which accounts
for more than 90 percent of malignant lymphoma in Japan, is
estimated to be approximately 124,000, and DLBCL is reported to
account for approximately 30 to 40 percent of NHL.i,ii,iii
About Follicular Lymphoma (FL) FL is the second most
frequent B-cell lymphoma after DLBCL, and accounts for 10 to 20
percent of NHL. Grade 3B disease, which is reported to account for
5 to 10 percent of FL, is treated according to aggressive
lymphoma.iv,v
About EPKINLY™ (epcoritamab) Epcoritamab 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 towards target cell types.
EPKINLY 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 (EPKINLY™) was approved in the United States in
May 2023 and is indicated for the treatment of adult patients with
relapsed or refractory (R/R) 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).
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 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.
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 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®
and HexElect®. EPKINLY™ is owned by AbbVie Biotechnology Ltd.
i Patient Survey in 2020 (MHLW),
https://www.mhlw.go.jp/toukei/list/10-20.html (as of August 3,
2023) ii Saito et al, Japanese Journal of Clinical Oncology 2020
Jan 24; 50(1), 96-97. DOI: 10.1093/jjco/hyz202 iii Ghielmini et al,
2013; Annals of Oncology. 2013 Mar;24(3):561-76. DOI:
10.1093/annonc/mds517 iv Practical Guidelines for Hematological
Malignancies 2018, Japanese Society of Hematology v Barraclough et
al, British Journal of Haematolgy, 2021 Oct; 195(1):15-24, DOI:
10.1111/bjh.17404 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.
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David Freundel, Senior Director, Global Communications &
Corporate Affairs T: +1 609 430 2481m; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations T:
+45 3377 9558; E: acn@genmab.com
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