TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced the presentation of secondary endpoint
results from the Phase 3 ENGOT-OV16/NOVA trial of niraparib at the
2017 Society for Gynecologic Oncology (SGO) Annual Meeting on
Women’s Cancer, March 12 to 15, 2017 by Dr. Sven Mahner, M.D.,
Director, Department of Gynecology and Obstetrics, University of
Munich.
“The results of several secondary endpoints from
the ENGOT-OV16/NOVA trial, including chemotherapy-free interval
(CFI), time to second subsequent therapy (TSST), and
progression-free survival 2 (PFS-2), demonstrate the positive and
durable treatment effect of niraparib in a broad population of
patients with ovarian cancer, regardless of germline BRCA mutation
status,” said Mary Lynne Hedley, Ph.D., President and COO of
TESARO. “An assessment of progression-free survival in
patients who have progressed on treatment received after completing
the NOVA study treatment (PFS-2) compared to their first
progression while on the NOVA study (PFS) indicates that niraparib
does not decrease the benefit of subsequent treatment.”
Niraparib is the only PARP inhibitor that has
shown 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.
Secondary Endpoint
Results:Niraparib Significantly Improved
Chemotherapy-free Interval (CFI) Among patients who were
germline BRCA mutation (gBRCAmut) carriers, the niraparib arm
successfully achieved statistical significance over the control arm
for the secondary endpoint of CFI, with a hazard ratio of 0.26 (95%
CI, 0.166-0.409). The median CFI for patients treated with
niraparib was 22.8 months, compared to 9.4 months for control
(p<0.0001).
Among patients without germline BRCA mutations
(non-gBRCAmut), the niraparib arm successfully achieved statistical
significance over the control arm for the secondary endpoint of
CFI, with a hazard ratio of 0.50 (95% CI, 0.370-0.666). The median
CFI for patients treated with niraparib was 12.7 months, compared
to 8.6 months for control (p<0.0001).
Niraparib Significantly Improved Time to
First Subsequent Treatment (TFST) Among patients who were
germline BRCA mutation carriers, the niraparib arm successfully
achieved statistical significance over the control arm for the
secondary endpoint of TFST, with a hazard ratio of 0.31 (95% CI,
0.205-0.481). The median TFST for patients treated with niraparib
was 21.0 months, compared to 8.4 months for control
(p<0.0001).
Among patients without germline BRCA mutations,
the niraparib arm successfully achieved statistical significance
over the control arm for the secondary endpoint of TFST, with a
hazard ratio of 0.55 (95% CI, 0.412-0.721). The median TFST for
patients treated with niraparib was 11.8 months, compared to 7.2
months for control (p<0.0001).
Niraparib Had No Impact on the Efficacy
of Next-Line TherapyFor a pooled group of patients who
have progressed on subsequent therapy (including patients with
germline BRCA mutations and without germline BRCA mutations), each
patient’s initial progression-free survival interval was subtracted
from the progression-free survival 2 interval, which showed no
reduction in benefit of niraparib treatment on the effectiveness of
subsequent chemotherapy, with a hazard ratio of 1.02 (95% CI,
0.765-1.349). In the NOVA study, a HR of 1.0 demonstrates that the
impact of niraparib on efficacy of the subsequent therapy was
clinically indistinguishable from the impact of placebo control on
the efficacy of the subsequent therapy.
Progression-free Surivival-2 and Overall
Survival are Immature, but Favor NiraparibPFS-2 data were
statistically significant and favored niraparib over control for
patients in both the gBRCAmut cohort (HR 0.48; 95% CI, 0.242-0.687)
and non-gBRCAmut cohort (HR 0.69; 95% CI, 0.494-0.964). Given the
relatively long PFS patients experienced on niraparib, PFS-2 was
immature, with only 30% of events captured for patients in the
gBRCAmut cohort and only 50% of events captured for patients in the
non-gBRCAmut cohort. Data for overall survival were also immature
(HR 0.73; 95% CI, 0.480 to 1.125; p=0.1545), as fewer than 20% of
events had occurred at the time of analysis.
Phase 3 ENGOT-OV16/NOVA Trial
Results The ENGOT-OV16/NOVA trial is an international
Phase 3, double-blind, placebo-controlled study that enrolled 553
patients with recurrent ovarian cancer who had achieved either a
partial or complete response (PR or CR) to their most recent
platinum-based chemotherapy. Niraparib significantly increased PFS
in patients with and without germline BRCA mutations as compared to
control, and the magnitude of benefit was similar for patients
entering the trial with a PR or a CR. Results also showed that
treatment with niraparib reduced the risk of disease progression or
death by 73% in patients with germline BRCA mutations (HR 0.27) and
by 55% in patients without germline BRCA mutations (HR 0.45).
Niraparib is the only PARP inhibitor that has shown 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.
The most common grade 3/4 adverse reactions to
niraparib in the NOVA trial included thrombocytopenia (29%), anemia
(25%), neutropenia (20%), and hypertension (9%). The majority of
hematologic adverse events were managed via dose modification.
Discontinuation of therapy due to thrombocytopenia, neutropenia and
anemia occurred in 3.3%, 1.9% and 1.4% of patients,
respectively.
About NiraparibNiraparib 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 U.S. Food and Drug
Administration (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
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.
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. 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.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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