Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food
and Drug Administration (FDA) has granted Breakthrough Therapy
designation for the Company’s investigational agent CO-1686 as
monotherapy for the treatment of second-line EGFR mutant NSCLC in
patients with the T790M mutation. The Breakthrough Therapy designation
was granted based on interim efficacy and safety results from an ongoing
Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral,
targeted covalent (irreversible) inhibitor of mutant forms of the
epidermal growth factor receptor (EGFR) for the treatment of non-small
cell lung cancer in patients with initial activating EGFR mutations as
well as the dominant resistance mutation T790M.
“We very much appreciate this designation by FDA, which recognizes the
meaningful benefit CO-1686 may provide patients with T790M positive
NSCLC,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
“This designation is well timed for us as well, as the increased
interaction with FDA that it provides will come as we are initiating our
registration studies and preparing to submit our initial New Drug
Application (NDA) by mid-2015.”
Interim results from an ongoing Phase 1/2 study of CO-1686 were
presented at the 4th European Lung Cancer Conference (ELCC)
in Geneva in late March. An objective response rate of 64 percent in 14
of 22 evaluable T790M positive patients was observed. CO-1686 is
well-tolerated, with only one patient who discontinued treatment with
CO-1686 due to adverse events. There was no evidence of systemic
wild-type EGFR inhibition.
The next update of CO-1686 clinical data will be presented at the 2014
American Society of Clinical Oncology Annual Meeting in a Clinical
Science Symposium titled, “Targeting EGFR: The Next 10 Years”, taking
place on Saturday, May 31 in Chicago.
The Company is currently enrolling two Phase 2 expansion cohorts of its
Phase 1/2 study in EGFR mutant patients with the T790M mutation. Data
from the expansion cohorts, combined with data from the TIGER2 study, in
T790M positive patients directly after progression on their first and
only TKI therapy, are expected to serve as the basis of an NDA
submission for CO-1686 by mid-2015.
About Breakthrough Therapy Designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA
Safety and Innovation Act and is intended to expedite development and
review of drugs to treat serious or life-threatening medical conditions
when preliminary clinical evidence demonstrates that the drug may have
substantial improvement on at least one clinically significant endpoint
over available therapies. Breakthrough Therapy designation includes all
the features of the Fast Track designation, as well as more intensive
guidance from the FDA on a drug’s clinical development program.
About CO-1686
CO-1686 is a novel, oral, targeted covalent (irreversible) inhibitor of
the cancer-causing mutant forms of epidermal growth factor receptor
(EGFR) currently being studied for the treatment of non-small cell lung
cancer (NSCLC). CO-1686 was designed to selectively target both the
initial activating EGFR mutations as well as the T790M resistance
mutation, while sparing wild-type, or “normal” EGFR at anticipated
therapeutic doses. Accordingly, it has the potential to treat NSCLC
patients with EGFR mutations both as a first-line or second-line
treatment with a reduced toxicity profile compared to current EGFR
inhibitor therapies. The Company is currently studying CO-1686 in Phase
2 expansion cohorts of NSCLC patients with activating EGFR mutations who
have failed initial EGFR-directed therapy and have developed the T790M
resistance mutation.
About EGFR and Lung Cancer
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. NSCLC progresses rapidly with a five-year survival rate in
advanced NSCLC patients of less than five percent. EGFR activating
mutations occur in approximately 10 to 15 percent of NSCLC cases in
Caucasian patients and approximately 30 to 35 percent in East Asian
patients. These patients experience significant tumor response to
Tarceva and Iressa, which are first-generation EGFR inhibitors. However,
most patients ultimately progress on Tarceva and Iressa therapy, with
approximately 60 percent of patients developing acquired resistance from
a second, or “gatekeeper” mutation, T790M.
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 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.
Copyright Business Wire 2014