TESARO Announces Expansion to Second Stage of JASPER Trial of ZEJULA® in Combination With TSR-042 in Non-Small Cell Lung Can...
September 04 2018 - 4:15PM
TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical
company, today announced it has initiated the second stage of the
JASPER study that is designed to assess clinical benefit of ZEJULA®
in combination with an anti-PD-1 antibody in first-line non-small
cell lung cancer (NSCLC) patients. The decision to advance the
trial was based on achieving the protocol defined response criteria
in the initial cohort of 16 treated patients with high PD-L1
expression, of which 14 were evaluable for a response. Nine of the
14 patients had objective responses by RECIST criteria at the time
of the analysis1; with all 14 patients experiencing tumor
shrinkage.
“These JASPER data provide preliminary evidence
that the combination of ZEJULA and an anti-PD-1 antibody could be
active as a first-line treatment for patients with non-small cell
lung cancer and high levels of PD-L1 expression,” said Mary Lynne
Hedley, Ph.D., President and COO of TESARO. “In the second stage of
the trial, 36 additional patients will be enrolled and treated with
ZEJULA in combination with TSR-042, our anti-PD-1 antibody. TSR-042
is the foundation of our lung cancer strategy, and is also being
studied as a monotherapy in our GARNET trial in anti-PD-(L)1 naïve
patients who have progressed on chemotherapy, and in combination
with TSR-022, our anti-TIM-3 antibody, in AMBER, a study in
late-line NSCLC patients that have progressed after anti-PD-(L)1
therapy. We look forward to sharing lung cancer data from both
GARNET and AMBER at the Society for the Immunotherapy of Cancer
(SITC) Annual Meeting in November.”
About the JASPER Clinical
TrialJASPER is a Phase 2, open-label, single arm trial
designed to evaluate the safety and efficacy of ZEJULA in
combination with an anti-PD-1 antibody for the treatment of
first-line NSCLC. Patients were enrolled in stage 1 of the
study and received a starting dose of 200 milligrams of niraparib
once per day and 200 milligrams Q3 weeks of an anti-PD-1 antibody.
The primary endpoint of stage 1 of the study was objective response
rate (ORR) per RECIST. Other endpoints include durability of
response, disease control rate, progression free survival (PFS),
overall survival (OS) and safety and tolerability.
About ZEJULA®
(Niraparib)Niraparib is marketed in the United States and
Europe under trade name ZEJULA®. ZEJULA (niraparib) is a
poly(ADP-ribose) polymerase (PARP) inhibitor indicated 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.
ZEJULA (niraparib) Select Important
Safety InformationMyelodysplastic Syndrome/Acute Myeloid
Leukemia (MDS/AML) was reported in patients treated with ZEJULA in
some 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.
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
Kate RauschDirector, Investor
Relations+1.781.257.2505 or krausch@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.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our clinical
development plans, our intent to enroll the second stage or the
JASPER trial, and our intent to present GARNET and AMBER data in
the second half of 2018. Forward-looking statements in this release
involve substantial risks and uncertainties that could cause our
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 the execution and completion of clinical trials and
regulatory submissions, uncertainties surrounding the timing of
availability of data from clinical trials, uncertainties
surrounding potential actions by regulatory authorities such as the
US FDA, risks related to manufacturing and supply, risks related to
intellectual property, and other matters that could affect our
ongoing and planned development programs, and/or 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, 2017, and Quarterly Report on Form 10-Q for
the quarter ended June 30, 2018.
1 Includes both confirmed and unconfirmed responses.
Tesaro, Inc. (NASDAQ:TSRO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tesaro, Inc. (NASDAQ:TSRO)
Historical Stock Chart
From Apr 2023 to Apr 2024