MONTREAL, Oct. 17,
2023 /CNW/ - AbbVie (NYSE: ABBV), today
announced that EPKINLY™ (epcoritamab
injection/epcoritamab for injection) has received Health Canada
authorization with conditions. It is the first and only
subcutaneous (SC) T-cell engaging bispecific antibody for the
treatment of adult patients with relapsed or refractory (R/R)
diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
DLBCL transformed from indolent lymphoma, high grade B-cell
lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or
follicular lymphoma Grade 3B (FLG3b)
after two or more lines of systemic therapy and who have previously
received or are unable to receive CAR-T cell therapy.1
EPKINLY has been issued marketing authorization with conditions,
pending the results of clinical trials to verify its clinical
benefit. EPKINLY is being co-developed by AbbVie and Genmab as
part of the companies' oncology collaboration.
DLBCL is a type of aggressive, fast-growing non-Hodgkin's
lymphoma (NHL), a cancer that develops in the lymphatic system and
affects B cells, a type of white blood cell. DLBCL is the most
common type of NHL. Although DLBCL is often curable, many patients
are refractory to, or relapse after first-line treatment with
standard chemoimmunotherapy.2 For R/R patients, several
targeted therapies including T-cell mediated treatments have
recently emerged. However, convenient and readily-available
subcutaneous single agent therapies or off-the-shelf treatment
options are limited.1,2,3,4,5,6
"As a non-chemotherapy, single-agent treatment, EPKINLY is a
novel treatment option that fills an unmet need for Canadian
patients with relapsed or refractory large B-cell lymphoma after at
least two prior lines of therapy," says Dr. John Kuruvilla, Hematologist in the Division of
Medical Oncology and Hematology, Princess Margaret Cancer Centre.
"I am looking forward to being able to provide this treatment
option to my patients and have confidence it will have a unique
place in therapy."
EPKINLY's authorization is based on the positive results of the
EPCORE™ NHL-1 clinical trial (NCT03625037)10, in
which EPKINLY delivered an overall response rate of 63
percent, a complete response rate of 39 percent and
median duration of response of 12 months in heavily pretreated R/R
DLBCL patients.1
"DLBCL is an aggressive cancer type that can rapidly progress
and resist treatment. Patients with RR DLBCL need innovative
treatment options," says Antonella
Rizza, CEO, Lymphoma Canada. "Lymphoma Canada welcomes
the authorization of epcoritamab and the hope it brings for
patients living with RR DLBCL."
"Health Canada's authorization
of EPKINLY as a new treatment option with a novel mechanism of
action for the treatment of third line DLBCL patients is an
important milestone in our commitment to transforming standards of
care for blood cancer patients through advancing our innovative
oncology pipeline to make a remarkable impact on the lives of
Canadian patients," says Tracey
Ramsay, Vice President and General Manager, AbbVie
Canada.
About the Health Canada Authorization
The Health Canada authorization is based on the data from the
open-label, multi-cohort, multicenter, single-arm trial (EPCORE
NHL-1; NCT03625037) conducted to evaluate EPKINLY, administered
subcutaneously, as monotherapy in patients with relapsed or
refractory large B-cell lymphoma (LBCL) after two or more lines of
systemic therapy. In this cohort (n=157), patients had received a
median of 3 (range, 2 to 11) prior therapies, including 39% with
prior chimeric antigen receptor (CAR) T-cell therapy (CAR-T).
The majority (83%) had been refractory to their last therapy (29%
refractory to CAR-T). The primary efficacy endpoint was overall
response rate (ORR) determined by Lugano criteria (2014). Results
showed an ORR of 63%. The median time to response (TTR)
was 1.4 months and the median time to CR was 2.7 months. The
median duration of response (mDOR) was 12.0 months.
About EPKINLY
EPKINLY is an IgG1-bispecific antibody
created using Genmab's proprietary
DuoBody® technology. Genmab's DuoBody-CD3
technology is designed to direct cytotoxic T cells selectively to
elicit an immune response towards target cell types. It is designed
to simultaneously bind to CD3 on T cells and CD20 on B-cells and
induces T cell mediated killing of CD20+ cells.5,7,8,9
EPKINLY comes as a concentrate for solution, for SC injection, with
each vial containing 4 mg in 0.8 mL (5 mg/mL) and a solution for SC
injection, with each vial containing 48 mg in 0.8 mL (60 mg/mL) of
epcoritamab.
AbbVie and Genmab 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
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.
Please consult the EPKINLY™ Product Monograph at
abbvie.ca.
About AbbVie in Oncology
At AbbVie, we are committed
to transforming standards of care for multiple blood cancers while
advancing a dynamic pipeline of investigational therapies across a
range of cancer types. Our dedicated and experienced team joins
forces with innovative partners to accelerate the delivery of
potentially breakthrough medicines. We are evaluating more than 20
investigational medicines in over 300 clinical trials across some
of the world's most widespread and debilitating cancers. As we work
to have a remarkable impact on people's lives, we are committed to
exploring solutions to help patients obtain access to our cancer
medicines.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines and solutions that solve serious
health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across
several key therapeutic areas – immunology, oncology, neuroscience,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us
at www.abbvie.ca. Follow AbbVie Canada on X
(Twitter), Instagram or find us on LinkedIn.
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1 Epkinly
(epcoritamab injection/for injection) product monograph. AbbVie
Corporation. Available at:
https://www.abbvie.ca/en/our-science/products.html. October
2023.
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2 Sehn et
al, 2020
|
3 What is
Lymphoma. Lymphoma Coalition.
https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24,
2023.
|
4 Kanas G,
Ge W, Quek RGW, et al. Leukemia & Lymphoma.
2022;63(1):54-63.
|
5 Crump M,
Neelapu SS, Farooq U, et
al. Blood. 2017;130(16):1800-1808.
|
6 Chao
MP. Cancer Manag Res. 2013;5:251-269.
|
7 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.
|
8 Rafiq S,
Butchar JP, Cheney C, et al. "Comparative Assessment of Clinically
Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia
Cells Reveals Divergent NK Cell, Monocyte, and Macrophage
Properties." J. Immunol. 2013;190(6):2702-2711.
DOI: 10.4049/jimmunol.1202588.
|
9 Singh V,
Gupta D, Almasan A. "Development of Novel Anti-Cd20 Monoclonal
Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking
to Improve Immunotherapy Response." J Cancer Sci
Ther. 2015;7(11):347-358. DOI:
10.4172/1948-5956.1000373.
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10 EPCORE NHL-1
clinicaltrial.gov
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SOURCE AbbVie Canada