TESARO Announces Niraparib Data Presentations at the 2017 SGO Annual Meeting on Women’s Cancer
March 12 2017 - 8:38AM
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced two niraparib presentations at the 2017
Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s
Cancer, March 12 to 15, 2017, in National Harbor, Maryland.
Please visit TESARO during SGO at Booth #325 for
information about VARUBI®, niraparib and our pipeline.
Presentation Details:
Monday, March 13, 2017 10:45 AM to 11:45 AM ENGOT-OV16/NOVA:
Results of secondary efficacy endpoints of niraparib maintenance
therapy in ovarian cancer Abstract: 8084, Oral Presentation,
Location: Hall A, Time: 11:10 AM Monday, March 13, 2017 3:30 PM –
5:00 PM and Tuesday, March 14, 2017 3:30 PM – 4:30 PMA Phase 3,
randomized, double-blind, placebo-controlled, multicenter study of
niraparib maintenance treatment in patients with advanced ovarian
cancer following response on frontline platinum-based chemotherapy
– Trial-in-progress (PRIMA)Abstract:8121, Poster Presentation 203,
Location: Hall BC |
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About Niraparib
Niraparib is an oral, once-daily PARP inhibitor
that is currently being evaluated in three pivotal trials. In
pre-clinical studies, niraparib was found to concentrate in the
tumor relative to plasma, delivering selective, greater than 90%
durable PARP inhibition and a persistent anti-tumor effect.
TESARO is building a robust niraparib franchise
by assessing activity across multiple tumor types and by evaluating
several potential combinations of niraparib with other
therapeutics. The ongoing development program for niraparib
includes a Phase 3 trial in patients who have received first-line
treatment for ovarian cancer (the PRIMA trial), a registrational
Phase 2 trial in patients who have received multiple lines of
treatment for ovarian cancer (the QUADRA trial), and a Phase 3
trial for the treatment of patients with germline BRCA-mutated,
metastatic breast cancer (the BRAVO trial). Several combination
studies are also underway, including trials of niraparib plus
pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has
licensed rights to develop and commercialize niraparib specifically
for patients with prostate cancer worldwide, except in Japan.
The niraparib New Drug Application (NDA) has
been accepted for priority review by the FDA and is supported by
data from the ENGOT-OV16/NOVA trial, a double-blind,
placebo-controlled, international Phase 3 study that enrolled 553
patients, either with or without a germline BRCA mutation, with
recurrent ovarian cancer following complete or partial response to
their most recent platinum-based chemotherapy. The full results of
the ENGOT-OV16/NOVA trial were presented in detail at the European
Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on
October 8, 2016 by Dr. Mansoor Raza Mirza, M.D., Medical Director
of the Nordic Society of Gynecologic Oncology (NSGO) and principal
investigator. These data were simultaneously published in the New
England Journal of Medicine.
Regulatory applications are under review for
niraparib in the U.S. and Europe and TESARO expects to launch
niraparib in the U.S. in the first half of 2017 and in Europe by
year-end 2017, pending regulatory approvals. Niraparib is an
investigational agent and, as such, has not been approved by the
U.S. FDA, European Medicines Agency (EMA), or any other regulatory
agencies.
About Ovarian
CancerApproximately 22,000 women are diagnosed each year
with ovarian cancer in the United States, and more than 65,000
women are diagnosed annually in Europe. Ovarian cancer is the fifth
most frequent cause of cancer death among women. Despite high
response rates to platinum-based chemotherapy in the second-line
advanced treatment setting, approximately 85% of patients will
experience recurrence within two years. Without an active treatment
following chemotherapy, the majority of women who have responded to
platinum-based chemotherapy undergo “watchful waiting” – a period
without any anti-cancer treatment during which a patient and their
healthcare provider will monitor signs of the disease returning. If
approved, niraparib may address the difficult “watchful waiting”
periods experienced by patients with recurrent ovarian cancer in
between cycles of platinum-based chemotherapy.
About TESAROTESARO is an
oncology-focused biopharmaceutical company dedicated to improving
the lives of cancer patients by acquiring, developing and
commercializing safer and more effective therapeutics. For more
information, visit www.tesarobio.com.
Investor/Media Contact:Jennifer
DavisVice President, Corporate Affairs & Investor
Relations+1.781.325.1116 or jdavis@tesarobio.com
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
TESARO, 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. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this release 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 expectations with
respect to niraparib regulatory submissions and approvals, and
other matters that could affect the availability or commercial
potential of our drug candidates. TESARO undertakes no obligation
to update or revise any forward-looking statements. TESARO
undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of the Company in general, see TESARO's
Annual Report on Form 10-K for the year ended December 31, 2015,
and its Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016.
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