May 12, 2014 11:20am EDT
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Achieved Primary Endpoint of Complete Response (CR) in the Delayed
Period (24 to 120 Hours) Following Initiation of Chemotherapy
Achieved Key Secondary Endpoints of CR in the Acute and Overall
Periods
Achieved All Secondary Endpoints, Including No Significant Nausea
Adverse Event Profile Consistent with Earlier Clinical Trials
New Drug Application (NDA) Submission to U.S. FDA On Track for
Mid-2014
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), reported that its licensee, TESARO, Inc.
(Nasdaq:TSRO), announced positive top-line results from the third and
final Phase 3 trial of rolapitant, an investigational neurokinin-1
(NK-1) receptor antagonist in development for the prevention of
chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in
this trial, which enrolled patients receiving cisplatin-based, highly
emetogenic chemotherapy (HEC), successfully achieved statistical
significance over the standard therapy arm for the primary and all
secondary endpoints. The adverse event profile for rolapitant remains
consistent with that seen in previous clinical studies.
The third Phase 3 study of rolapitant was an international, multicenter,
randomized, double-blind, active-controlled study that enrolled 532
cancer patients receiving cisplatin-based chemotherapy regimens at a
dose equal to or greater than 60 mg/m 2 . Patients were
randomized to receive either control, which consisted of a 5-HT 3
receptor antagonist plus dexamethasone, or 200 milligrams of oral
rolapitant plus control. The rolapitant arm in this study successfully
achieved statistical significance over the control arm for the primary
endpoint of complete response (CR) in the delayed phase of CINV. In
addition, the rolapitant arm also successfully achieved statistical
significance over the control arm for the key secondary endpoints of CR
in the acute (0 to 24 hour) and overall (0 to 120 hour) phases of CINV,
for the secondary endpoint of no significant nausea, and for all other
secondary endpoints.
Safety and tolerability data for patients who received rolapitant were
similar to the results for those who received control, and were
consistent with earlier clinical studies. The most frequently observed
adverse events were balanced across treatment arms and included fatigue,
constipation and loss of appetite.
TESARO continues preparations in support of a submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) in
mid-2014. The oral rolapitant NDA will include data from one Phase 3
study in patients receiving moderately emetogenic chemotherapy (MEC), in
addition to one Phase 2 and two Phase 3 trials in patients receiving
cisplatin-based, highly emetogenic chemotherapy (HEC), including the
trial announced today. The top-line results of the Phase 3 trial in MEC
and the prior Phase 3 trial in HEC were previously announced by TESARO
in December 2013.
Rolapitant is an investigational agent and, as such, has not been
approved by the U.S. FDA or any regulatory agencies.
About Rolapitant
Rolapitant is a potent and selective neurokinin-1 (NK-1) receptor
antagonist with an extended plasma half-life that is being developed for
the prevention of chemotherapy-induced nausea and vomiting (CINV). NK-1
receptors are highly concentrated in the brain and bind the neurokinin
substance P. Activation of NK-1 receptors plays a central role in nausea
and vomiting induced by emetogenic stimuli, including certain cancer
chemotherapies. NK-1 receptor antagonists have been demonstrated to
improve the management of nausea and vomiting experienced by cancer
patients undergoing chemotherapy. The safety and tolerability of single
and repeat doses of rolapitant have been assessed in more than 2,500
healthy volunteers and patients. Rolapitant is being developed both in
oral and intravenous formulations. TESARO licensed exclusive rights for
the development, manufacture, commercialization and distribution of
rolapitant from OPKO.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing
chemotherapy and, if not prevented, may possibly result in a delay or
even discontinuation of chemotherapy treatment. Prolonged nausea and
vomiting may result in unwanted weight loss, dehydration and
malnutrition, as well as hospitalization.
About TESARO, Inc.
TESARO is an oncology-focused biopharmaceutical company dedicated to
improving the lives of cancer patients by acquiring, developing and
commercializing safer and more effective therapeutics.
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding expected benefits of rolapitant,
whether rolapitant will ever be successfully developed or
commercialized, the expected timing of an NDA, Tesaro’s ability to
market and sell rolapitant, as well as other non-historical statements
about our expectations, beliefs or intentions regarding our business,
technologies and products, financial condition, strategies or prospects.
Many factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements. These factors include those described in our
Annual Reports on Form 10-K filed and to be filed with the Securities
and Exchange Commission and in our other filings with the Securities and
Exchange Commission, as well as the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that rolapitant and/or any
of our compounds or diagnostic products under development may fail, may
not achieve the expected results or effectiveness and may not generate
data that would support the approval or marketing of products for the
indications being studied or for other indications, that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released May 12, 2014
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