No difference in overall survival versus gemcitabine in hENT1-low
hENT1 biomarker also not predictive for gemcitabine outcomes
BOULDER, Colo.--(BUSINESS WIRE)--Nov. 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
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.
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
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.
Source: Clovis Oncology, Inc.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022