Clovis Oncology Announces Data Presentations at 2016 ASCO Annual Meeting
May 19 2016 - 4:40PM
Business Wire
- New rucaparib data to be highlighted in
poster presentations
- Rolling New Drug Application (NDA)
submission for rucaparib for the treatment of patients with
advanced ovarian cancer expected to complete during Q2 2016
- European Marketing Authorization
Application (MAA) planned in Q4 2016
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced its
presence at the 2016 American Society of Clinical Oncology (ASCO)
Annual Meeting, where it will share updated results from clinical
studies of rucaparib. ASCO will take place June 3-7, 2016 in
Chicago.
“We look forward to providing updates on rucaparib data in
ovarian cancer, including in patients with mutations beyond BRCA,
as well as the first presentation of our pancreatic cancer data,”
said Patrick J. Mahaffy, CEO and President of Clovis Oncology.
“These datasets demonstrate rucaparib’s encouraging clinical
activity and tolerability profile in the treatment of ovarian and
pancreatic cancers. Both represent diseases in which BRCA mutations
play a significant role in certain patients, as well as areas where
additional treatment options are very much needed.”
Rucaparib is the Company’s oral, potent, small molecule
inhibitor of PARP1-3 currently being developed for the treatment of
ovarian cancer, specifically in patients with tumors with BRCA
mutations and other DNA repair deficiencies beyond BRCA, including
those with high genomic loss of heterozygosity (LOH) commonly
referred to as “BRCA-like." Data from rucaparib studies are the
subject of three poster presentations at the conference:
Abstract 4110 – RUCAPANC: An open-label, phase 2 trial of the
PARP inhibitor rucaparib in patients (pts) with pancreatic cancer
(PC) and a known deleterious germline or somatic BRCA mutation.
- Susan M. Domchek, MD, University of
Pennsylvania, Philadelphia, PA
- Saturday, June 4 from 8:00am-11:30am
CDT
- Location: Hall A, Poster Board
#102
Abstract 5540 – Refinement of prespecified cutoff for genomic
loss of heterozygosity (LOH) in ARIEL2 part 1: A phase II study of
rucaparib in patients (pts) with high grade ovarian carcinoma
(HGOC).
- Robert L. Coleman, MD, The University
of Texas MD Anderson Cancer Center, Houston, TX
- Monday, June 6 from 1:00pm-4:30pm
CDT
- Location: Hall A, Poster Board
#363
Abstract 5549 – Feasibility of monitoring response to the PARP
inhibitor rucaparib with targeted deep sequencing of circulating
tumor DNA (ctDNA) in women with high grade serous carcinoma on the
ARIEL2 trial.
- Anna Piskorz, PhD, Cancer Research UK
Cambridge Institute, University of Cambridge
- Monday, June 6 from 1:00pm-4:30pm
CDT
- Location: Hall A, Poster Board
#372
About Rucaparib
Rucaparib is an oral, potent small molecule inhibitor of PARP1-3
being developed for the treatment of ovarian cancer, specifically
in patients with tumors with BRCA mutations and other DNA repair
deficiencies beyond BRCA, including those with high genomic loss of
heterozygosity (LOH) commonly referred to as “BRCA-like." Clovis is
also exploring rucaparib in other solid tumor types with
significant BRCA and BRCA-like populations, including prostate,
breast and gastroesophageal cancers. Rucaparib was granted
Breakthrough Therapy designation by the U.S. FDA in April 2015.
Clovis holds worldwide rights for rucaparib.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160519006693/en/
Clovis OncologyAnna Sussman,
303-625-5022asussman@clovisoncology.comorBreanna Burkart,
303-625-5023bburkart@clovisoncology.com
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