[October 23, 2014] |
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Clovis Oncology Announces First Patient Enrolled in Lucitanib Phase 2 Study in Squamous Non-small Cell Lung Cancer
BOULDER, Colo. --(Business Wire)--
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that its global
Phase 2 study of lucitanib in patients with FGFR1-amplified squamous
non-small cell lung cancer (NSCLC) has commenced and the first patient
has been dosed at a U.S. study site. Lucitanib is the Company's oral,
potent inhibitor of the tyrosine kinase activity of fibroblast growth
factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth
factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth
factor receptors alpha and beta (PDGFR a-ß).
"The lucitanib data presented to date in patients with FGF-aberrant
breast cancer are very encouraging, and we know that FGFR1
amplification occurs in approximately 15 percent of patients with
squamous non-small cell lung cancer," said Dr. Benjamin Besse, Head of
Thoracic Oncology, Institut Gustave Roussy, and the lead investigator of
the study in squamous NSCLC. "Accordingly, we are very enthusiastic to
explore lucitanib in this selected population of patients with lung
cancer, for whom there is significant need for novel therapies."
"Less than a year after acquiring lucitanib, we are commencing a broad
clinical development program, which includes this study in FGFR1-amplified
squamous NSCLC, as well as our ongoing study currently underway in
FGF-aberrant breast cancer," said Patrick J. Mahaffy, President and CEO
of Clovis Oncology. "We are enthusiastic about the opportunity to
explore lucitanib in these indications, and potentially in other solid
tumors exhibiting FGFR pathway activation."
The Phase 2 study will enroll FGFR1-amplified squamous NSCLC
patients with advanced disease who have progressed on at least one prior
line of therapy. The global study will assess objective response rate,
progression-free survival, and duration of response, as well as the
safety, tolerability, and pharmacokinetics of lucitanib.
Lucitanib is unique among tyrosine kinase inhibitors being developed for
cancer therapy, as it effectively targets fibroblast growth factor
receptors (FGFR)1-3, vascular endothelial growth factor receptors
(VEGFR)1-3, and platelet-derived growth facto receptors (PDGFR) alpha
and beta with minimal off-target activity. This selectivity profile
allows lucitanib to provide a potential benefit to cancer patients by
targeting multiple pathways of tumor development. Specifically, by
targeting the FGFR pathway, lucitanib can have a direct antitumor effect
in FGF/FGFR driven tumors such as breast or lung cancers harboring
amplification of the FGFR1 gene. In addition, by targeting the FGFR,
VEGFR and PDGFR receptors lucitanib also can inhibit the development of
blood vessels that are required by the tumor to grow and spread.
In addition to this Clovis-sponsored Phase 2 study in squamous NSCLC, a
global development program for lucitanib in breast cancer is underway,
which includes the Clovis-sponsored Phase 2 study in FGF-aberrant
advanced breast cancer being conducted in the U.S., the
Servier-sponsored FINESSE study of lucitanib monotherapy being conducted
in Europe, Canada and Australia as well as the Servier-sponsored INES
study evaluating lucitanib in combination with fulvestrant after failure
of endocrine therapy.
About FGF-aberrant Squamous NSCLC
Lung cancer is the most common cancer worldwide with 1.7 million new
cases annually, with NSCLC accounting for almost 85 percent of all lung
cancers. Squamous non-small cell lung carcinoma is a sub-type of NSCLC
derived from the cells which line the lung's major airways. Squamous
NSCLC accounts for approximately 25-30 percent of lung cancer cases, and
is generally diagnosed in patients with a history of smoking. FGFR1-amplification
is a hallmark of squamous NSCLC and observed in roughly 15 percent of
squamous NSCLC tumors. There are no approved targeted therapies
specifically for patients with squamous NSCLC.
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity
of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular
endothelial growth factor receptors 1 through 3 (VEGFR1-3) and
platelet-derived growth factor receptors alpha and beta (PDGFR a-ß).
Clovis owns exclusive development and commercial rights to lucitanib on
a global basis, excluding China. Lucitanib rights to markets outside of
the U.S. and Japan have been sublicensed to Servier. Clovis is
collaborating with Servier on the global clinical development of
lucitanib.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops diagnostic tools that direct a
compound in development to the population that is most likely to benefit
from its use.
To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve substantial risks and uncertainties
that could cause our clinical development programs, future results,
performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in the
initiation of future clinical trials, availability of data from ongoing
clinical trials, expectations for regulatory approvals, and other
matters that could affect the availability or commercial potential of
our drug candidates. Clovis Oncology undertakes no obligation to update
or revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well as
risks relating to the business of the company in general, see Clovis
Oncology's Annual Report on Form 10-K for the year ended December 31,
2013 and its other reports filed with the Securities and Exchange
Commission.
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