TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced a substantial expansion of its niraparib
clinical development program. Following the landmark results of the
Phase 3 NOVA trial of niraparib, a comprehensive portfolio review,
and the FDA approval of ZEJULA™ (niraparib) for patients with
recurrent ovarian cancer, TESARO is implementing its plans to
initiate registration strategies in the settings of metastatic
ovarian, breast and lung cancers.
“Based on the unprecedented results of the NOVA
trial in women with recurrent ovarian cancer, we previously
announced the expansion and refinement of our PRIMA and QUADRA
trials to include a broad patient population, and in the case of
PRIMA, eliminated the enrollment requirement for a biomarker
selected tumor. With the approval of ZEJULA in hand, we will now
begin to execute on our plans to pursue potentially
transformational applications of niraparib in a broad range of
metastatic cancer indications,” said Mary Lynne Hedley, Ph.D.,
President and COO of TESARO. “We plan to expand our first-line
ovarian cancer strategy to include a combination study that
assesses the potential benefit of niraparib plus an anti-PD-1
antibody in the maintenance setting and initiate a clinical study
of niraparib in combination with bevacizumab in patients with a
first recurrence of ovarian cancer, with an intent to replace
chemotherapy in this setting. We remain strongly committed to
studying niraparib in the breast cancer setting and also expect to
initiate a new trial of niraparib in combination with an anti-PD-1
antibody in women with metastatic triple-negative breast
cancer. Finally, our goal to move niraparib into indications
beyond ovarian and breast cancers encompasses plans to initiate a
registration strategy for the first-line treatment of patients with
metastatic non-small cell lung cancer that includes a phase 2 trial
of niraparib in combination with an anti-PD-1 antibody in patients,
regardless of PDL-1 tumor expression, and a phase 3 trial of
niraparib in combination with an anti-PD-1 antibody in patients
with high levels of PDL-1 tumor
expression.”
Niraparib is the only PARP inhibitor approved in
the U.S. for the maintenance treatment of women with recurrent
ovarian, fallopian or primary peritoneal cancers. This approval was
based upon the results of a randomized, prospectively designed
Phase 3 clinical trial where niraparib demonstrated a clinically
meaningful increase in progression-free survival (PFS) in women
with recurrent ovarian cancer following a response to
platinum-based chemotherapy.
The BRAVO study is assessing niraparib in
patients with breast cancer who are germline BRCA mutation
carriers. This study is sponsored by TESARO and is being conducted
by Breast International Group (BIG) and the European Organisation
for Research and Treatment of Cancer (EORTC). Following a recent
interim analysis of data by the independent data monitoring
committee (IDMC), TESARO believes the BRAVO study is unlikely to
produce data that is interpretable and therefore suitable for
registration in this indication. A large number of patients in the
chemotherapy control arm did not continue in the trial long enough
to receive their first radiological scan, which is required to
assess disease progression, resulting in an unusually high rate of
censoring in the control arm. At this time, TESARO believes this is
likely associated with the desire of patients who carry germline
BRCA mutations to be treated with a PARP inhibitor rather than
chemotherapy and the increased availability of PARP inhibitors. A
final determination as to whether the planned enrollment in BRAVO
should be completed will be made by the Steering Committee in the
near term. No safety concerns have been noted by the IDMC with
respect to niraparib. Approximately 5-10% of women with breast
cancer are germline BRCA mutation carriers. TESARO expects the
results and experience gained from the BRAVO trial to be supportive
of the planned trial of niraparib in combination with an anti-PD-1
antibody in women with metastatic triple-negative breast cancer.
Approximately 15-20% of women with breast cancer have triple
negative breast cancer.
The expanded niraparib clinical development
program now includes the following:
Ovarian Cancer
OvCa 3000-03-003: A Phase 3
clinical trial of niraparib in combination with an anti-PD-1
antibody in comparison to niraparib in first-line maintenance
treatment of patients with advanced ovarian cancer who have
responded to platinum induction therapy.
OvCa 3000-03-002: A Phase 3
clinical trial of niraparib in combination with bevacizumab in
comparison to standard of care in patients with a first recurrence
of ovarian cancer.
PRIMA: A Phase
3 clinical trial of niraparib in patients with advanced ovarian
cancer who have responded to platinum induction therapy.
TOPACIO: A
Phase 2 trial to evaluate the preliminary safety and efficacy of
niraparib plus KEYTRUDA® in patients with triple negative breast
cancer and in patients with platinum resistant recurrent ovarian
cancer being conducted by TESARO in collaboration with Merck.
QUADRA: A
registration trial of niraparib for the treatment of patients with
recurrent ovarian cancer who have received three or four regimens
of therapy.
AVANOVA: An
NSGO (Nordic Society of Gynaecological Oncology) Phase 1/2 trial
(in collaboration with ENGOT) evaluating niraparib plus bevacizumab
in patients with recurrent ovarian cancer.
Breast Cancer
TNBC 3000-03-004: A Phase 3
clinical trial of niraparib in combination with anti- PD-1 antibody
in comparison to standard of care in patients with advanced triple
negative breast cancer.
TOPACIO: A
Phase 2 clinical trial to evaluate the safety and efficacy of
niraparib plus KEYTRUDA® in patients with triple negative breast
cancer and patients with platinum resistant recurrent ovarian
cancer being conducted by TESARO in collaboration with Merck.
Lung Cancer
Lung 3000-02-001: A Phase 2
clinical trial of niraparib in combination with an anti-PD-1
antibody in patients with advanced NSCLC and niraparib alone in
patients with advanced squamous cell carcinoma of the lung.
Lung 3000-03-001: A Phase 3
clinical trial of niraparib in combination with an anti-PD-1
antibody in comparison to anti-PD-1 alone in patients with advanced
NSCLC and high levels of PDL-1 tumor expression.
Prostate Cancer
Janssen Biotech has licensed rights to develop
and commercialize niraparib specifically for patients with prostate
cancer worldwide, except in Japan.
TESARO Investor Conference Call and
WebcastTESARO will webcast a conference call with
investors and analysts today, March 27, 2017 at 4:30 PM ET.
Investors and analysts may access this call by dialing (877)
853-5334 (U.S. and Canada) or (970) 315-0307 (international); no
passcode is necessary. During this conference call, TESARO
management will review the approval of ZEJULA and expanded
niraparib development program, as well as answer questions from
investors and analysts. This event will be webcast live and
archived for 30 days, and may be accessed from the TESARO Investor
Events and Presentations webpage at www.tesarobio.com.
About ZEJULA (Niraparib)ZEJULA
(niraparib) is an oral, once-daily poly(ADP-ribose) polymerase
(PARP) 1/2 inhibitor that is indicated in the U.S. for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in a
complete or partial response to platinum-based chemotherapy. In
preclinical studies, ZEJULA concentrates in the tumor relative to
plasma, delivering greater than 90% durable inhibition of PARP 1/2
and a persistent antitumor effect.
Select Important Safety
Information Myelodysplastic Syndrome/Acute Myeloid
Leukemia (MDS/AML) was reported in patients treated with ZEJULA in
all clinical studies. Discontinue ZEJULA if MDS/AML is
confirmed.
Hematologic adverse reactions (thrombocytopenia,
anemia and neutropenia) have been reported in patients treated with
ZEJULA. Do not start ZEJULA until patients have recovered
from hematological toxicity caused by previous chemotherapy (≤
Grade 1). Monitor complete blood counts weekly for the first month,
monthly for the next 11 months of treatment, and periodically after
this time.
Hypertension and hypertensive crisis have been
reported in patients treated with ZEJULA. Monitor blood pressure
and heart rate monthly for the first year and periodically
thereafter during treatment with ZEJULA. Closely monitor patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can
cause fetal harm. Advise females of reproductive potential of
the potential risk to a fetus and to use effective contraception
during treatment and for six months after receiving the final
dose. Because of the potential for serious adverse reactions
in breastfed infants from ZEJULA, advise a lactating woman not to
breastfeed during treatment with ZEJULA and for one month after
receiving the final dose.
In clinical studies, the most common adverse
reactions included: thrombocytopenia, anemia, neutropenia, nausea,
constipation, vomiting, abdominal pain/distension,
mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased
appetite, headache, insomnia, nasopharyngitis, dyspnea, rash and
hypertension.
Please see full Prescribing Information for
additional Safety Information.
About TESAROTESARO is an
oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more
information, visit www.tesarobio.com, and follow us on Twitter and
LinkedIn.
Investor/Media
Contact: Jennifer Davis Vice President, Corporate
Affairs & Investor Relations +1.781.325.1116 or
jdavis@tesarobio.com
Forward Looking Statements
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 include statements
regarding the proposed design, details and timing of our plans for
new niraparib clinical studies for the first-line treatment of
patients in ovarian, breast and lung cancer indications, the
potential transformational nature of those proposed indications,
and our belief that the BRAVO trial is unlikely to produce
interpretable data suitable to support a registration of niraparib
in breast cancer. These 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, uncertainties inherent in the execution and
completion of clinical trials, uncertainties surrounding the
timing of availability of data from clinical trials, uncertainties
surrounding discussions with and potential actions by regulatory
authorities, uncertainties surrounding enrollment in clinical
trials, risks associated with our reliance upon third parties for
the conduct of clinical trials, risks related to manufacturing and
supply, and other matters that could affect the timing of
availability of data from or initiation of our clinical trials.
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,
2016.
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