– Epcoritamab shows clinically meaningful
efficacy in challenging-to-treat, highly refractory LBCL
patients
– Total patient population achieved
overall response rate (ORR) of 63 percent and complete response
(CR) of 39 percent; CAR T-naïve patients achieved 69 percent ORR
and 42 percent CR; patients previously treated with CAR T achieved
a 54 percent ORR and 34 percent CR
– Safety
profile is consistent with previous findings
observed
– Results were reported as part of a
late-breaking oral presentation selected for the Presidential
Symposium at EHA
NORTH
CHICAGO, Ill., June 11,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced primary results from the large B-cell lymphoma (LBCL)
expansion cohort in the EPCORE™ NHL-1 phase 2 clinical trial
evaluating epcoritamab (DuoBody®-CD3xCD20), an
investigational subcutaneous bispecific antibody. In this study,
epcoritamab demonstrated efficacy with durable responses in
patients who had previously received at least two prior lines of
anti-lymphoma therapy including chimeric antigen receptor (CAR)
T-cell therapy. These data were presented today in a late-breaking
oral presentation as a part of the Presidential Symposium at the
27th Annual Meeting of the European Hematology
Association (EHA2022) in Vienna,
Austria (Abstract #LB2364).
"Large B-cell lymphoma is a fast-growing, difficult to treat
type of aggressive non-Hodgkin's lymphoma. Some treatment
approaches like chemotherapy and immunotherapy have been in place
for decades and newer treatments like CAR T-cell therapies involve
multiple steps before a patient can begin treatment so there is
still a need for additional treatment options," said Professor
Catherine Thieblemont, head of the
Hemato-Oncology Department at Hôpital Saint-Louis, Paris,
France. "The data presented today suggest that epcoritamab
has the potential to provide patients living with LBCL an
accessible, effective treatment with a safety profile that may
fulfill an unmet need."
The study cohort, which included 157 relapsed/refractory LBCL
patients, previously treated with a median of three lines of prior
therapy, demonstrated an overall response rate (ORR) of 63 percent
and a complete response (CR) rate of 39 percent. Baseline
characteristics included 61 percent of patients who were refractory
to primary treatment, 20 percent who had prior autologous stem cell
transplantation (ASCT), and 39 percent who were treated with CAR
T-cell therapy (75 percent of those refractory to CAR T). Patients
enrolled in the study who were naïve to CAR T-cell therapy achieved
a 69 percent ORR and a 42 percent CR and patients who received
prior CAR T-cell therapy achieved a 54 percent ORR and a 34 percent
CR. After a median follow up of 10.7 months, the median duration of
response (mDOR) was estimated to be 12 months, while the mDOR among
patients achieving a CR was not reached, with 89 percent still in
CR at nine months. Topline results from this study were previously
announced in April 2022.
The safety profile of epcoritamab was consistent with previous
findings. The majority of treatment-emergent AEs (TEAEs) occurred
during the first 12 weeks of treatment and resolved. The most
common TEAEs of any grade (greater than or equal to 15 percent)
included cytokine release syndrome (CRS) (49.7 percent), pyrexia
(23.6 percent), fatigue (22.9 percent), neutropenia (21.7 percent),
diarrhea (20.4 percent), injection site reaction (19.7 percent),
nausea (19.7 percent) and anemia (17.8 percent). The most common
Grade 3 or 4 TEAEs (greater than or equal to 5 percent) included
neutropenia (14.6 percent), anemia (10.2 percent), neutrophil count
decrease (6.4 percent), and thrombocytopenia (5.7 percent). The
observed Grade 3 CRS was 2.5 percent. No Grade 4/5 CRS was
observed.
"The epcoritamab data suggests a potentially compelling clinical
profile for patients with relapsed/refractory LBCL, which currently
have limited treatment options," said Mohamed Zaki, M.D., Ph.D., vice president and
head, global oncology development, AbbVie. "Our partnership with
Genmab allows us to continue exploring new standards of care for
patients with blood cancer."
Epcoritamab is being co-developed by AbbVie and Genmab as part
of the companies' broad oncology collaboration. The companies
remain committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy for a variety of hematologic
malignancies, including an ongoing phase 3, open-label, randomized
trial evaluating epcoritamab as a monotherapy in patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (NCT:
04628494).
About Large B-cell Lymphoma (LBCL)
LBCL is a
fast-growing type of non-Hodgkin's lymphoma (NHL) – a cancer that
develops in the lymphatic system – that affects B-cell lymphocytes,
a type of white blood cell. There are an estimated 150,000 new LBCL
cases each year globally. LBCL includes DLBCL, which is the most
common type of NHL worldwide and accounts for approximately 31
percent of all NHL cases.1,2,3,4
About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 an
open-label, multi-center safety and preliminary efficacy trial of
epcoritamab including 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-NHL, including
LBCL and DLBCL, the most common subtype of LBCL. The dose
escalation findings, which determined the recommended phase 2 dose,
were published in The Lancet in 2021. In the phase
2 expansion part, additional patients are treated with epcoritamab
to further explore the safety and efficacy of epcoritamab in three
cohorts of patients with different types of relapsed/refractory
B-NHLs who had limited therapeutic options.
The primary endpoint of the phase 2 expansion part was ORR as
assessed by an IRC. Secondary efficacy endpoints included duration
of response, complete response rate, 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 Epcoritamab
Epcoritamab is an investigational
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. 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.5 CD20 is expressed on B-cells
and a clinically validated therapeutic target in many B-cell
malignancies, including diffuse large B-cell lymphoma, follicular
lymphoma, mantle cell lymphoma and chronic lymphocytic
leukemia.6,7 Epcoritamab is being co-developed by
Genmab and AbbVie as part of the companies' broad oncology
collaboration.
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. For more information, please visit
http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines 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, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie Forward-Looking Statements
Some
statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
1 "Diffuse Large B-Cell Lymphoma." Lymphoma Research
Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/. Date
accessed: 7 June 2022.
2 "Non-Hodgkin Lymphoma." Lymphoma Research Foundation,
https://lymphoma.org/aboutlymphoma/nhl/. Date accessed:
7 June 2022.
3 Sehn, Salles. "Diffuse Large B-Cell Lymphoma." N Engl
J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612
4 Martelli, Ferreri, Agostinelli, et al. "Diffuse large
B-cell lymphoma." Crit Rev Oncol Hematol. 2013;87(2):146-71. DOI:
10.1016/j.critrevonc.2012.12.009
5 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
6 Rafiq, Butchar, Cheney, 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
7 Singh, Gupta, Almasan. "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
View original
content:https://www.prnewswire.com/news-releases/abbvie-announces-late-breaking-results-from-phase-2-trial-of-investigational-epcoritamab-duobody-cd3xcd20-in-patients-with-relapsedrefractory-large-b-cell-lymphoma-lbcl-at-the-european-hematology-association-eha-annual-con-301566151.html
SOURCE AbbVie