Clovis Oncology Announces Negative Outcome of CO-101 in Pivotal LEAP
Pancreatic Cancer Study
No difference in overall survival versus gemcitabine in hENT1-low patients
hENT1 biomarker also not predictive for gemcitabine outcomes
BOULDER, Colo. -- November 12, 2012
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the results from its LEAP
(Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 versus
gemcitabine in metastatic pancreatic cancer. There was no difference in
overall survival between the two arms in either the primary analysis of the
hENT1-low patient population, or in the overall intent-to-treat population.
Median survival in each arm was approximately six months with a hazard ratio
of 0.99, and is entirely consistent with the survival results from other
gemcitabine studies in metastatic pancreatic cancer. Toxicities were
comparable between the two arms, and no differences were observed in any
subgroup analyses. Key prognostic variables, including performance status and
age, were balanced between the hENT1-low and -high groups.
Importantly, the study also demonstrated that, contrary to the results of
numerous published retrospective studies, hENT1 status had no impact on
survival for patients on gemcitabine.
“We are obviously disappointed with these results, which are unambiguous,”
said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “We would like
to thank the investigators, and mostly the patients, who participated in this
trial and we wish the best for the developers of other agents to treat this
devastating, very difficult to treat disease.”
As a consequence of these results, Clovis will suspend all development of
CO-101, pending further evaluation of the LEAP data, and focus its resources
on the three product candidates in its portfolio.
Clovis’ product pipeline includes: CO-1686, an orally-available, epidermal
growth factor receptor (EGFR) covalent inhibitor, currently in a Phase I/II
study for the treatment of non-small cell lung cancer (NSCLC) in patients with
initial activating EGFR mutations as well as the T790M primary resistance
mutation; rucaparib, an orally-available, small molecule poly (ADP-ribose)
polymerase (PARP) inhibitor being developed for certain ovarian and breast
cancers that is currently in a Phase I/II clinical program both as monotherapy
and in combination with chemotherapy; and, a novel cKIT inhibitor targeting
resistance mutations for the treatment of gastrointestinal stromal tumors
(GIST), currently in the discovery phase.
For both CO-1686 and rucaparib, the Company currently anticipates presenting
Phase I data at ASCO in June 2013. For CO-1686, Clovis expects to have
evidence of efficacy data in the T790M population from the ongoing Phase I/II
study in the second half of 2013, and, if data are positive, commence a
registration study in the first half of 2014. Pending positive data from the
rucaparib studies, the Company plans to initiate a global registration study
in 2013 in platinum-sensitive ovarian cancer patients with deficiencies in
BRCA and other DNA repair genes.
Clovis anticipates ending 2012 with approximately $140 million in cash, which
provides sufficient resources to demonstrate meaningful evidence of efficacy
for both CO-1686 and rucaparib.
Conference Call Details
Clovis will hold a conference call to discuss these results later this
morning, November 12, at 8:30 am Eastern time. The conference call will be
simultaneously webcast on the Company’s website at www.clovisoncology.com, and
archived for future review. Dial-in numbers for the conference call for
institutional investors and analysts are as follows: US 866.730.5766,
international 857.350.1590, passcode 99196369.
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, and has additional offices in San
Francisco, California and Cambridge, UK.
Forward Looking Statements
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, including the
results of our clinical trials, the corresponding development strategies for
companion diagnostics for our product candidates, 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
Breanna Burkart, 303-625-5023
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