|[May 31, 2014]
Clovis Oncology Announces Encouraging Data from Phase 1/2a Study Evaluating Lucitanib in Advanced Solid Tumors
BOULDER, Colo. --(Business Wire)--
Clovis Oncology (NASDAQ:CLVS) today announced results from an ongoing
Phase 1/2a monotherapy study evaluating lucitanib, the Company's novel,
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 (PDGFRa-ß). Data from the study were
presented today in an oral presentation by Professor Jean-Charles Soria
at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
"Treatment with lucitanib in this Phase 1/2 clinical trial provided
durable objective RECIST responses in patients with solid tumors.
Specifically, patients with advanced breast cancer with FGF receptor or
FGF ligand alterations experienced a 50% objective response rate and
progression free survival of 9.6 months," said Professor Carlos L.
Arteaga, MD, Associate Director for Clinical Research, Director
of the Center for Cancer Targeted Therapies, and Director
of the Breast Cancer Program at the Vanderbilt-Ingram
Cancer Center of Vanderbilt University. "Although results
to date from this ongoing clinical trial are early, they are still
encouraging as they suggest that determination of genetic alterations in
the FGF pathway could be important for identifying cancer patients most
likely to benefit from treatment with lucitanib."
"We are extremely encouraged with the 50 percent response rate observed
with lucitanib therapy in heavily pre-treated FGF-aberrant patients,"
said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "These
results support the further exploration of lucitanib in tumor types with
FGFR pathway activation, and our Phase 2 program in breast cancer and
squamous non-small cell lung cancer commences enrollment shortly. In
parallel, two breast cancer trials are underway in Europe, sponsored by
our development partner Servier."
Lucitanib is a potent inhibitor of fibroblast growth factor receptor 1-3
(FGFR1-3), vascular endothelial growth factor receptors 1-3 (VEGFR1-3)
and platelet-derived growth factor receptors alpha and beta (PDGFRa-ß).
The FGF, VEGF and PDGF cellular signaling pathways each play a role in
tumor growth and angiogenesis. FGF-related genetic changes, in
particular, have been described in several cancer types, including
breast and squamous non-small cell lung cancer, particularly in the
context of acquired reistance to initial therapies.
Over 100 patients have been treated with lucitanib in this ongoing Phase
1/2a study. All patients treated in the dose-expansion cohorts have been
identified as having FGF-aberrant or angiogenesis-sensitive solid
tumors. Patients in the Phase 1 dose escalation portion of the study
were treated with once-daily (QD) dosing of 5mg, 10mg, 20 mg or 30mg of
lucitanib, data from which led to a recommended continuous dose of 10 to
20mg QD for the cohort-expansion phase of the study.
Evidence of Activity
Objective responses have been seen at starting doses of 10, 15 and 20mg
In the FGF-aberrant subgroup, defined as amplification of either FGFR1
or an FGF ligand-containing amplicon (11q), six of twelve breast cancer
patients achieved objective responses (50 percent), and the remaining 50
percent experienced stable disease. For these patients, median
progression free survival was 9.6 months and median duration of response
was 11.5 months.
In the angiogenesis subgroup, most of whom had progressed on prior
anti-angiogenic therapy, 26 percent (7/27) of patients with measureable
disease achieved an objective response (3 Complete Responses (CRs) and 4
Partial Responses (PRs); and 56 percent (15/27) experienced stable
disease. Median progression-free survival was 5.9 months in the
angiogenesis sub-group and median duration of response was 7.5 months.
Notably, ten patients treated in this study have maintained objective
responses for greater than one year.
Safety and Tolerability
Most drug-related adverse events (AEs) experienced by patients on study
were mild or asymptomatic. The most common drug-related AEs observed
were hypertension (75 percent), proteinuria (51 percent), asthenia (37
percent) and hypothyroidism (32 percent). Hypertension, proteinuria and
hypothyroidism are thought to be a result of VEGFR2 inhibition, and
represent on-target toxicities.
Lucitanib is an oral, potent, selective tyrosine kinase inhibitor of
FGFR1-3, VEGFR1-3 and PDGFRa-ß. Clovis, which holds exclusive U.S. and
Japanese rights to lucitanib, is collaborating with its development
partner, Les Laboratoires Servier, on the clinical development of
lucitanib, initially targeting solid tumors with FGFR pathway
activation, including breast cancer and squamous non-small cell lung
A broad Phase 2 program is being initiated to explore lucitanib in
multiple indications, including a U.S. study in patients with
treatment-refractory FGF-aberrant breast cancer and a global study in
patients with advanced squamous NSCLC with FGFR1 amplification. In
parallel with these Clovis-sponsored studies expected to begin shortly,
two Servier-sponsored studies of lucitanib in patients with advanced
breast cancer are underway in Europe.
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. Clovis Oncology is headquartered in Boulder, Colorado.
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 our
clinical development programs for our drug candidates, the corresponding
development pathways of our companion diagnostics, actions by the FDA,
the EMA (News - Alert) or other regulatory authorities regarding whether to approve
drug applications that may be filed, as well as their decisions
regarding drug labeling, and other matters that could affect the
availability or commercial potential of our drug candidates or companion
diagnostics, including competitive developments. Clovis Oncology
does not undertake to update or revise any forward-looking statements. A
further description of risks and uncertainties can be found in Clovis
Oncology's filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K and its reports on Form 10-Q
and Form 8-K.
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