NORTH CHICAGO, Ill.,
Jan. 4, 2022 /PRNewswire/
-- AbbVie (NYSE: ABBV) announced today that the U.S. Food and
Drug Administration (FDA) granted Breakthrough Therapy Designation
(BTD) to investigational telisotuzumab vedotin (Teliso-V) for the
treatment of patients with advanced/metastatic epidermal growth
factor receptor (EGFR) wild type, nonsquamous non-small cell lung
cancer (NSCLC) with high levels of c-Met overexpression whose
disease has progressed on or after platinum-based therapy.
The FDA's BTD program is intended to expedite the development
and review of medicines with preliminary clinical evidence that
indicate that the investigational treatment may demonstrate
substantial improvement over existing therapies on one or more
clinically significant endpoints.1
Despite advances in treatment, lung cancer remains the leading
cause of cancer-related deaths in both men and women in the U.S.
and throughout the world. It is the most common cancer in males and
the third most common cancer in females worldwide, with incidence
rates (per 100,000) of 31.5 and 14.6, respectively.2
Approximately 85% of lung cancers are classified as
NSCLC.3 Patients whose disease progresses after
standard of care therapies, including prior platinum, have limited
treatment options and poor prognosis.
"Patients with non-small cell lung cancer have a high unmet need
and Teliso-V has the potential to provide them with an additional
treatment option to manage their disease," said Mohamed Zaki, M.D., Ph.D., Vice President and
Global Head of Oncology Clinical Development at AbbVie. "Today's
announcement marks an important step in our mission to advance new
oncology treatments across tumor types to improve standards of care
for patients with cancer."
This BTD designation is supported by data from LUMINOSITY (Study
M14-239), 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 primary endpoint is overall response rate (ORR)
per central review in patients with ≥ 12 weeks follow-up. Among
patients with EGFR WT nonsquamous NSCLC, ORR was 53.8% in the c-Met
high group and 25.0% in the c-Met intermediate group at a
previously reported interim analysis. Teliso-V is also being
evaluated in combination with osimertinib in the ongoing Phase 1
study M14-237 in patients with previously treated c-Met
overexpressing NSCLC. In addition, it will be further evaluated as
monotherapy in patients with previously treated c-Met
overexpressing NSCLC in the randomized Phase 3 study TeliMET
NSCLC-01 (Study M18-868).
AbbVie will present Teliso-V data at upcoming scientific
congresses. Additional information on clinical trials for Teliso-V
is available at www.clinicaltrials.gov.
Teliso-V is an investigational antibody-drug conjugate (ADC)
targeting c-Met, a receptor tyrosine kinase that is overexpressed
in tumors including NSCLC. Teliso-V is not approved by any
regulatory authority and its safety and efficacy have not been
established. Currently there are no approved cancer therapies
specifically for patients with c-Met overexpressing NSCLC.
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.
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 2020 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 U.S. Food and Drug Administration.
Breakthrough Therapy.
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies. Accessed
December 17, 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 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.
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