WALTHAM, Mass., March 27, 2017 /PRNewswire/ -- TESARO, Inc.
(NASDAQ: TSRO), an oncology-focused biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
has approved ZEJULA™ (niraparib), an oral, once-daily
poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance
treatment of women with recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are in a complete or partial
response (CR or PR) to platinum-based chemotherapy. ZEJULA is the
first PARP inhibitor to be approved by the FDA that does not
require BRCA mutation or other biomarker testing. TESARO
anticipates launching ZEJULA in the
United States in late April.
Multimedia materials accompanying this release are available at:
https://www.multivu.com/players/English/8050551-tesaro-zejula-niraparib-fda-approval/.
ZEJULA is the only PARP inhibitor that has demonstrated a
clinically meaningful increase in progression-free survival (PFS)
in women with recurrent ovarian cancer, regardless of BRCA
mutation or biomarker status, in a randomized, prospectively
designed Phase 3 clinical trial. ZEJULA offers oral, once-daily
dosing, enabling convenient administration for maintenance
treatment. FDA approval of ZEJULA is based upon data from the
international Phase 3 ENGOT-OV16/NOVA trial, a double-blind,
placebo-controlled study that enrolled 553 patients with recurrent
ovarian cancer who had achieved either a PR or CR to their most
recent platinum-based chemotherapy. Approximately two-thirds of
study participants did not have germline BRCA mutations.
Progression in the NOVA study was determined by robust, unbiased,
blinded central review, to be the earlier of radiographic or
clinical progression. ZEJULA significantly increased PFS in
patients with and without germline BRCA mutations as
compared to control. Treatment with ZEJULA reduced the risk of
disease progression or death by 74% in patients with germline
BRCA mutations (HR 0.26) and by 55% in patients without
germline BRCA mutations (HR 0.45). The magnitude of benefit
was similar for patients entering the trial with a PR or a CR.
The most common grade 3/4 adverse reactions to ZEJULA in the
NOVA trial included thrombocytopenia (29%), anemia (25%),
neutropenia (20%), and hypertension (9%). The majority of
hematologic adverse events were successfully managed via dose
modification, and discontinuation of therapy due to
thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and
1.4% of patients, respectively. Following dose adjustment based on
individual tolerability, the incidence of grade 3/4
thrombocytopenia was low; approximately <1% after month 2.
Please see the "Select Important Safety Information" below for
warnings, precautions and adverse events.
"We are so gratified to bring this unique new medicine to women
with ovarian cancer, and would like to thank the patients who gave
selflessly to participate in this trial with the assistance of
their caregivers and physicians. We consider clinical trial
participants to be the most important contributors to the success
of the ZEJULA clinical development program," said Mary Lynne Hedley, Ph.D., President and Chief
Operating Officer of TESARO. "We would also like to express
our appreciation to the FDA for its rapid and thorough assessment
of the ZEJULA application in less than three months after it was
accepted for review, as well as our partners at ENGOT for their
diligence and care in executing the NOVA clinical trial. TESARO is
committed to supporting women bravely facing ovarian cancer and we
are planning to work with patients, healthcare providers and payers
to ensure access to this paradigm-changing medicine."
"Despite high response rates to platinum-based treatment in
recurrent ovarian cancer patients, the effectiveness of such
chemotherapy diminishes over time. Unfortunately, progression
free survival generally gets shorter after each subsequent
treatment with a platinum-based chemotherapy regimen. Therefore, a
treatment like ZEJULA that can increase progression-free survival
after platinum therapy is very meaningful to patients and their
families," said Dr. Ursula
Matulonis, M.D., Director, Gynecologic Oncology at
Dana-Farber Cancer Institute and Professor of Medicine,
Harvard Medical School. "Until
recently, there have been few treatment advances for women with
recurrent ovarian cancer and even fewer options available for women
who do not harbor BRCA mutations. We are excited to have the
opportunity to offer appropriate patients an oral, once-daily
maintenance treatment that reduces the risk of cancer progression
and extends the time between courses of chemotherapy for patients
who have few treatment options."
"The approval of ZEJULA, the first maintenance therapy approved
in the U.S. for recurrent ovarian cancer, is extremely encouraging
for the ovarian cancer community," said Dr. Mansoor Raza Mirza, M.D., ENGOT-OV16/NOVA Study
Chair and Medical Director of the Nordic Society of Gynaecological
Oncology (NSGO). "The unique design of the NOVA study, which
included women both with and without germline BRCA
mutations, allowed us to determine that ZEJULA provides significant
progression-free survival improvement in a very broad patient
population. Having the option of prescribing ZEJULA without the
need for a diagnostic test could fundamentally change the way we
treat this disease from 'watch and wait' after a response to
chemotherapy, to active treatment. With the significant increase in
PFS observed in NOVA, I believe that we are changing the
course of disease for patients with ovarian cancer, regardless of
platinum sensitivity and independent of BRCA mutation or
biomarker status."
"Women with recurrent ovarian cancer often experience
considerable fear and anxiety about future recurrences," said
Audra Moran, President and CEO of
Ovarian Cancer Research Fund Alliance. "ZEJULA may offer patients
and their families a treatment option during this stressful period.
The ovarian cancer community is eager for new treatment options,
and we are glad that ZEJULA will be available to women that have
completed their platinum-based chemotherapy."
The full prescribing information for ZEJULA will be made
available at www.zejula.com. ZEJULA is administered at a starting
dose of 300 milligrams once per day, which can be modified based
upon individual tolerability. TESARO anticipates that ZEJULA will
be made available in the U.S. in late April. A Marketing
Authorisation Application for niraparib is under review by the
European Medicines Agency (EMA).
TESARO Investor Conference Call and Webcast
TESARO 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 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 Ovarian Cancer
Approximately 22,000 women are diagnosed with ovarian cancer each
year 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. Per NCCN guidelines, BRCA testing and
genetic counseling remain important components of the medical
workup for all patients upon a diagnosis with ovarian cancer.
About the ZEJULA™ (Niraparib) ENGOT-OV16/NOVA Clinical
Trial
ENGOT-OV16/NOVA was a double-blind, placebo-controlled,
international Phase 3 trial of niraparib that enrolled 553 patients
with recurrent ovarian cancer who were in a response to their most
recent platinum-based chemotherapy. Patients were enrolled into one
of two independent cohorts based on germline BRCA mutation
status. One cohort enrolled patients who were germline BRCA
mutation carriers (gBRCAmut), and the second cohort enrolled
patients who were not germline BRCA mutation carriers
(non-gBRCAmut) and included patients with HRD-positive and
HRD-negative tumors. Within each cohort, patients were randomized
2:1 to receive niraparib or placebo and were treated continuously
with placebo or 300 milligrams of niraparib, dosed as three 100
milligram tablets once per day, until progression. The primary
endpoint of this study was progression-free survival (PFS).
Secondary endpoints included patient-reported outcomes,
chemotherapy-free interval length, PFS 2, overall survival, and
other measures of safety and tolerability. More information
about this trial is available at
http://clinicaltrials.gov/show/NCT01847274.
Among patients who were germline BRCA mutation carriers,
the niraparib arm successfully achieved statistical significance
over the control arm for the primary endpoint of PFS, with a hazard
ratio of 0.26 (95% CI, 0.173-0.410). The median PFS for patients
treated with niraparib was 21.0 months, compared to 5.5 months for
control (p<0.0001). Niraparib also showed statistical
significance for patients in the non-germline BRCA mutant
cohort. The niraparib arm successfully achieved statistical
significance over the control arm for the primary endpoint of PFS,
with a hazard ratio of 0.45 (95% CI, 0.338-0.607). The median PFS
for patients treated with niraparib was 9.3 months, compared to 3.9
months for control (p<0.0001). Secondary endpoint
analyses, including chemotherapy-free interval, time to first
subsequent treatment, and PFS 2 were all statistically significant
and favored niraparib over control for patients in both the
gBRCAmut and non-gBRCAmut cohorts. Patient-reported
outcome results from validated survey tools indicated that
niraparib-treated patients reported no difference from control in
measures associated with quality of life.
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.
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.
Additional Clinical Trials of ZEJULA (Niraparib)
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) and a registrational Phase 2 trial in
patients who have received multiple lines of treatment for ovarian
cancer (the QUADRA trial). Several combination studies are also
underway, including trials of niraparib plus pembrolizumab (the
TOPACIO trial) and niraparib plus bevacizumab (the AVANOVA trial).
Janssen Biotech has licensed rights to develop and commercialize
niraparib specifically for patients with prostate cancer worldwide,
except in Japan.
About ZEJULA (Niraparib)
ZEJULA 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.
TOGETHER with TESARO™
TOGETHER with TESARO™ is a patient resource program
dedicated to supporting people living with cancer. The
program assists with access issues, so that patients with
cancer can be free to focus on treatment goals and simply
living life. It provides a full suite of
services to meet each patient's needs and individual
experience. A team of access and
affordability experts is available to
help oncology practices and patients gain access
to the medication they require. TOGETHER with TESARO
will continue to evolve and grow to meet provider
and patient needs. For more information, please visit
www.togetherwithtesaro.com or call 1-844-2TESARO
(1-844-283-7276).
About TESARO
TESARO 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.
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 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, risks associated with competition in the PARP market,
risks related to pricing and reimbursement, risks related to
manufacturing and supply, risks related to intellectual
property, and other risks and uncertainties that could
affect the availability or commercial potential of ZEJULA. 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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SOURCE TESARO, Inc.