- Teliso-V is an investigational antibody-drug
conjugate (ADC) for patients with previously treated nonsquamous
non-small cell lung cancer (NSCLC) with c-Met protein
overexpression.
- Biologics License Application (BLA) submission for
accelerated approval is supported by data from the Phase 2
LUMINOSITY trial (M14-239). Review of the BLA will be conducted
under FDA's Oncology Center of Excellence (OCE) Real-Time Oncology
Review (RTOR) program.
- There are currently no approved anti-cancer therapies
specifically for c-Met overexpressing NSCLC and if approved
Teliso-V would be the first-in-class therapy for this patient
population.
NORTH
CHICAGO, Ill., Sept. 27,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced submission of a Biologics License Application (BLA) to
the U.S. Food and Drug Administration (FDA) for accelerated
approval of telisotuzumab vedotin (Teliso-V) in adult patients with
previously treated, locally advanced or metastatic epidermal growth
factor receptor (EGFR) wild type, nonsquamous non-small cell lung
cancer (NSCLC) with c-Met protein overexpression.
Approximately 85% of lung cancers are classified as
NSCLC1 and despite advances in treatment, lung
cancer remains the leading cause of cancer-related deaths
throughout the world.2 The c-Met protein is a
receptor tyrosine kinase found to be overexpressed in approximately
25% of advanced EGFR wild type, nonsquamous NSCLC
patients3 and is associated with a poor
prognosis.4,5,6 Teliso-V is being evaluated within this
patient population who currently have very limited treatment
options.
"Patients with non-small cell lung cancer have unmet medical
needs and oncologists are looking for new treatment options for
these patients who unfortunately have a poor prognosis," said
Roopal Thakkar, M.D., executive vice
president, research and development, chief scientific officer,
AbbVie. "We are hopeful that Teliso-V will be a differentiated
treatment for certain patients as we look to elevate the
standards of care in oncology."
In December 2021, Teliso-V was
granted Breakthrough Therapy Designation by the FDA. The BLA
submission is supported by data from Phase 2 LUMINOSITY trial
(Study M14-239), an ongoing study designed to characterize the
safety and efficacy of Teliso-V in c-Met overexpressing NSCLC
populations. Data from the LUMINOSITY study were recently presented
at the 2024 American Society of Clinical Oncology congress and
topline data from this trial were shared in 2023. Teliso-V is being
further evaluated as a monotherapy in patients with previously
treated c-Met overexpressing NSCLC in the randomized Phase 3
confirmatory global study TeliMET NSCLC-01. Enrollment in the study
is underway and continues across global clinical trial sites.
Additional information on clinical trials for Teliso-V is
available at www.clinicaltrials.gov.
About Telisotuzumab Vedotin (Teliso-V)
Teliso-V is an investigational, first-in-class, c-Met protein
directed antibody-drug conjugate (ADC) designed to target c-Met
overexpressing tumors. c-Met is a receptor tyrosine kinase that can
be overexpressed in many solid tumors including NSCLC. Further
information on clinical trials for Teliso-V is available
at https://clinicaltrials.gov/. Teliso-V is not approved by
any health regulatory authority.
About the LUMINOSITY
Trial
The LUMINOSITY trial (M14-239), is an
ongoing Phase 2 study designed to identify the target NSCLC
populations that overexpress c-Met best suited for Teliso-V
monotherapy in the second-line or third-line setting, and then to
expand the groups to further evaluate efficacy in the selected
populations. The endpoints include overall response rate
(ORR), duration of response (DoR), disease control rate (DCR) and
progression-free survival (PFS) per independent central review
(ICR) as well as overall survival (OS).
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, bi-specific antibody 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 comprises approved and
investigational treatments for a wide range of blood and solid
tumors. We are evaluating more than 20 investigational medicines in
multiple 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 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.
References:
1 National Cancer Institute.
Non-small cell lung cancer treatment – health professional version.
https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc.
Accessed December 8, 2021.
2 Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL,
Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN
estimates of incidence and mortality worldwide for 36 cancers in
185 countries. CA: A Cancer Journal for Clinicians.
2024;74(3):229-63.
3 Ansell PJ, Baijal S, Liede A, et al. Prevalence and
Characterization of c-MET–Overexpressing Non-small Cell Lung Cancer
(NSCLC) Across Clinical Trial Samples and Real-world Patient
Cohorts From the City of Hope National Medical Center. Cancer
Research UK (CRUK) - Lung Cancer Conference; Manchester,
UK2022.
4 Liang H, Wang M. MET Oncogene in Non-Small Cell Lung
Cancer: Mechanism of MET Dysregulation and Agents Targeting the
HGF/c-Met Axis. Onco Targets Ther. 2020;13:2491-510.
5 Park S, Choi YL, Sung CO, et al. High MET copy number
and MET overexpression: poor outcome in non-small cell lung cancer
patients. Histol Histopathol. 2012;27(2):197-207.
6 Guo B, Cen H, Tan X, et al. Prognostic value of MET
gene copy number and protein expression in patients with surgically
resected non-small cell lung cancer: a meta-analysis of published
literatures. PLoS One. 2014;9(6):e99399.
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