- LUMINOSITY trial demonstrated compelling clinical benefits
across key endpoints
- Teliso-V is an investigational first-in-class, c-Met protein
directed antibody-drug conjugate (ADC) being studied in patients
with previously treated non-small cell lung cancer (NSCLC) with
c-Met overexpression
- Data from the study will be presented at a future medical
meeting and we will discuss with global health authorities the
potential to support an accelerated approval
NORTH
CHICAGO, Ill., Nov. 29,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced
today topline results from the single-arm Phase 2 LUMINOSITY trial
evaluating telisotuzumab-vedotin (Teliso-V) in patients with c-Met
protein overexpression, epidermal growth factor receptor (EGFR)
wild type, advanced/metastatic nonsquamous non-small cell lung
cancer (NSCLC). The results demonstrated a compelling overall
response rate per independent central review (ICR) of 35 percent
and 23 percent across c-Met High and c-Met Intermediate patients
respectively.
In addition, other endpoints demonstrated meaningful clinical
outcomes including median duration of response per ICR of 9
months and 7.2 months and a median overall survival of 14.6
months and 14.2 months across c-Met High and c-Met Intermediate
patients respectively.
The safety profile of Teliso-V was consistent with previous
findings and no new safety concerns were identified. Adverse events
with Teliso-V monotherapy were generally well managed and
tolerated. Full data from the LUMINOSITY study will be presented at
a future medical meeting and we will discuss with global health
authorities the potential to support an accelerated approval.
Approximately 85% of lung cancers are classified as
NSCLC1 and despite advances in treatment, lung cancer
remains the leading cause of cancer-related deaths in both men and
women throughout the world.2 C-Met protein
overexpression is found in approximately 25% of advanced EGFR wild
type NSCLC patients3 and is associated with a poor
prognosis for these patients.4,5,6 Teliso-V, an
investigational ADC, is being studied in this patient population
who have very limited treatment options and where there are
currently no approved therapies.
"The results of the Phase 2 LUMINOSITY trial are encouraging for
those patients with non-small cell lung cancer with c-Met
overexpression as there is a critical need for better care and
additional therapy options for them," said Ross Camidge, MD, PhD, University of Colorado Cancer Center, United States, and Principal Investigator for
the trial. "Today's announcement also provides confidence as we
continue to enroll patients into the Phase 3 TeliMET NSCLC-01 trial
and expand our understanding of Teliso-V's potential."
"Results from the Phase 2 LUMINOSITY trial mark an important
step forward for AbbVie's mission to advance new oncology
treatments across our ADC program targeting solid tumor types with
critical patient needs," said Roopal
Thakkar, M.D., senior vice president, development and
regulatory affairs and chief medical officer, AbbVie.
Teliso-V is being evaluated as a monotherapy in patients with
previously treated c-Met overexpressing EGFR wild type nonsquamous
NSCLC in the randomized Phase 3 study TeliMET NSCLC-01, which is
currently enrolling.
Teliso-V has also been granted several designations around the
world including Breakthrough Therapy Designation (BTD) by the U.S.
Food and Drug Administration (FDA) and Taiwanese health
authorities, SAKIGAKE designation in Japan by the Ministry of Health, Labour and
Welfare (MHLW), as well as being awarded an Innovation Passport by
the UK's Medicines and Healthcare products Regulatory Agency
(MHRA).
About Telisotuzumab-Vedotin (Teliso-V)
Teliso-V is an
investigational first-in-class, c-Met protein directed
antibody-drug conjugate (ADC) targeting patients with c-Met
overexpressing tumors. C-Met is a receptor tyrosine kinase that is
overexpressed in many solid tumors including NSCLC. Teliso-V is
being evaluated as a monotherapy in patients with previously
treated c-Met overexpressing EGFR wild type non squamous NSCLC in
the randomized Phase 3 study TeliMET NSCLC-01, which is currently
enrolling. In addition, it is being evaluated in combination with
osimertinib in the ongoing Phase 1 study M14-237, and as a
monotherapy in the Phase 2 LUMINOSITY study. Further information on
clinical trials for Teliso-V is available
at https://clinicaltrials.gov/. Currently there are no
approved cancer therapies specifically for patients with c-Met
overexpressing NSCLC. Teliso-V is not approved by any regulatory
authority and its safety and efficacy have not been
established.
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 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
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 2022 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. 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, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A.
Global cancer statistics 2018: GLOBOCAN estimates of incidence and
mortality worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018
Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. PMID:
30207593.
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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