- ABBV-383 is a B-cell maturation antigen (BCMA) bispecific
antibody T-cell engager being evaluated in relapsed/refractory
multiple myeloma (r/r MM)
- The CERVINO Phase 3 trial will evaluate the efficacy,
safety, and tolerability of ABBV-383 monotherapy compared with
standard available therapies (SATs) in patients with r/r MM who
have received at least two lines of prior therapy
NORTH
CHICAGO, Ill., June 5, 2024
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the
first patient has been treated with investigational ABBV-383 in the
CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation
antigen (BCMA) and CD3 bispecific antibody T-cell engager
composed of bivalent BCMA-binding domains allowing
for high BCMA-avidity and a low-affinity CD3 binding
domain.1 ABBV-383 is being evaluated in a Phase 3,
multicenter, randomized, open-label study compared with standard
available therapies in patients with r/r MM who received at least
two lines of prior therapy.
"Despite notable advances in treatment, most patients with
multiple myeloma will eventually relapse. Patients with advanced
disease, especially in the community setting, often have limited
access to novel treatment options and existing options have a high
treatment burden, including frequent dosing," said Dr. Peter Voorhees, clinical professor of medicine,
director of plasma cell disorders, Atrium Health Levine Cancer
Institute. "The CERVINO Phase 3 trial is designed to evaluate
the efficacy of ABBV-383 with monthly dosing and we look forward to
seeing the data as it emerges."
Multiple myeloma is a blood cancer characterized by abnormal
proliferation of plasma cells, which can cause end-organ damage and
is the second most commonly occurring blood cancer in the
world.2 An estimated 176,000 people globally were
diagnosed with multiple myeloma in 2020, and 117,000 people died
from the disease.3
"The start of the CERVINO Phase 3 trial marks an important step
forward in AbbVie's continued commitment to advance new oncology
treatments and elevate the standard of care for blood cancer
patients," said Mariana Cota
Stirner, M.D., vice president, therapeutic area head
oncology, hematology, AbbVie. "ABBV-383 is being evaluated with
monthly dosing from the beginning of treatment, with the goal of
maximizing treatment simplicity for physicians and patients, if
proven in the clinical trials."
About the CERVINO Study
CERVINO (NCT06158841) is a global, Phase 3, multicenter,
randomized, open-label, parallel-group study evaluating ABBV-383 in
adult patients (≥18 years) with r/r MM and an Eastern Cooperative
Oncology Group performance status ≤2 who received at least two
prior lines of therapy, including exposure to a PI, an IMiD, and an
anti-CD38 mAb. Patients who received prior BCMA-targeted therapy
will be excluded. Patients will be randomized 1:1 to receive
intravenous ABBV-383 60mg Q4W or the investigator's choice of SAT
(carfilzomib + dexamethasone, elotuzumab + pomalidomide +
dexamethasone, or selinexor + bortezomib + dexamethasone), and will
continue treatment until confirmed progressive disease or other
discontinuation criteria are met.
The dual primary end points are progression-free survival and
overall response rate. Secondary end points include overall
survival, complete response (CR) or better, very good partial
response or better, rate of minimum residual disease negativity,
and change in disease symptoms and physical functioning.
Approximately 140 sites globally will enroll approximately 380
total patients.
Additional information about the study can be found at
https://clinicaltrials.gov/ under the identifier NCT06158841.
About ABBV-383
ABBV-383 is an investigational distinctive BCMA x CD3 bispecific
antibody T-cell engager composed of bivalent high-avidity
BCMA-binding domains, a low-affinity CD3-binding domain designed to
reduce cytokine release, and a silenced Fc tail designed for an
extended half-life that may support once every 4-week (Q4W) dosing.
Clinical relevance of these structure activity relationships has
not been established.
BCMA is highly expressed on the surface of malignant plasma
cells in multiple myeloma, making it an ideal target for therapy.
BCMA plays a crucial role in the survival of myeloma cells by
promoting their growth and inhibiting their apoptosis (programmed
cell death).4
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care
for patients living with difficult-to-treat cancers. We are
advancing a dynamic pipeline of investigational therapies across a
range of cancer types in both blood cancers and solid tumors. We
are focusing on creating targeted medicines that either impede the
reproduction of cancer cells or enable their elimination. We
achieve this through various, targeted treatment modalities
including Antibody Drug Conjugates (ADCs), Immuno-Oncology, and
bi-specific and CAR-T platforms. Our dedicated and experienced team
joins forces with innovative partners to accelerate the delivery of
potential breakthrough medicines.
Today, our expansive oncology portfolio is comprised of approved
and investigational treatments for a wide range of blood and solid
tumors. We are evaluating more than 20 investigational medicines
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
us at http://www.abbvie.com/oncology.
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.com. Follow @abbvie on
LinkedIn, Facebook, Instagram, X (formerly Twitter), and
YouTube.
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 and uses
of future or conditional verbs, 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 expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. 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 2023 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, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 Foureau DM, Bhutani M, Robinson M, et al: Ex vivo
efficacy of BCMA-bispecific antibody TNB-383B in
relapsed/refractory multiple myeloma. EJHaem 1:113-121, 2020
2 International Myeloma Foundation. What is
Multiple
Myeloma? https://www.myeloma.org/what-is-multiple-myeloma
3 Cancer.Net. Multiple Myeloma:
Statistics. https://www.cancer.net/cancer-types/multiple-myeloma/statistics.
4 Cho SF, Anderson KC, Tai YT: Targeting B Cell
Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of
BCMA-Based Immunotherapy. Front Immunol 9:1821, 2018
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