|[March 25, 2014]
Exelixis Provides Update on Ongoing COMET-1 Phase 3 Pivotal Trial in Men with Metastatic Castration-Resistant Prostate Cancer
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Exelixis, Inc. (NASDAQ:EXEL) announced that the Independent Data
Monitoring Committee (IDMC) notified the company today that a planned
interim analysis of the COMET-1 phase 3 pivotal trial has been
completed, and that the IDMC recommended the trial proceed to its final
analysis. Exelixis continues to anticipate top-line data from COMET-1 in
About the COMET-1 Trial
COMET-1 is a randomized, double-blind, controlled trial designed to
enroll 960 patients with mCRPC who have progressed after treatment with
docetaxel, abiraterone and/or enzalutamide. All patients in the trial
have bone metastases and there is no limit to the number or type of
prior treatments. Patients were randomized 2:1 to receive cabozantinib
(60 mg daily) or prednisone (5 mg twice daily). The trial is
event-driven and has 90% power to detect a 25% reduction in the risk of
death (HR = 0.75) at the time of final analysis, which requires 578
events. The current interim analysis after 387 events was also planned
to assess if the trial achieved its primary endpoint; it did not include
a futility analysis. The secondary endpoint of the trial is bone scan
response as assessed by an independent radiology facility (IRF).
Cabozantinib inhibits the activity of tyrosine kinases including MET,
VEGFRs and RET. These receptor tyrosine kinases are involved in both
normal cellular function and in pathologic processes such as
oncogenesis, metastasis, tumor angiogenesis, and maintenance of the
COMETRIQ® (cabozantinib) is currently approved by the U.S. Food and Drug
Administration for the treatment of progressive, metastatic medullary
The European Commission granted COMETRIQ conditional approval for the
treatment of adult patients with progressive, unresectable locally
advanced or metastatic medullary thyroid carcinoma (MTC). Similar to
another drug approved in this setting, the approved indication states
that for patients in whom Rearranged during Transfection (RET) mutation
status is not known or is negative, a possible lower benefit should be
taken into account before individual treatment decisions.
Important Safety Information, including Boxed WARNINGS
WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE
Serious and sometimes fatal gastrointestinal perforations and
fistulas occur in COMETRIQ-treated patients.
Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated
COMETRIQ treatment results in an increase in thrombotic events, such
as heart attacks.
Wund complications have been reported with COMETRIQ.
COMETRIQ treatment results in an increase in hypertension.
Osteonecrosis of the jaw has been observed in COMETRIQ-treated
Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients
treated with COMETRIQ.
The kidneys can be adversely affected by COMETRIQ. Proteinuria and
nephrotic syndrome have been reported in patients receiving COMETRIQ.
Reversible Posterior Leukoencephalopathy Syndrome has been observed
Avoid administration of COMETRIQ with agents that are strong CYP3A4
inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or
severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.
Adverse Reactions - The most commonly reported adverse drug reactions
(=25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia
syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue,
oral pain, hair color changes, dysgeusia, hypertension, abdominal pain,
and constipation. The most common laboratory abnormalities (=25%) are
increased AST, increased ALT, lymphopenia, increased alkaline
phosphatase, hypocalcemia, neutropenia, thrombocytopenia,
hypophosphatemia, and hyperbilirubinemia.
Please see full U.S. prescribing information, including Boxed WARNINGS,
Please refer to the full European Summary of Product Characteristics for
full European Union prescribing information, including contraindication,
special warnings and precautions for use at www.sobi.com
Exelixis is a biotechnology company committed to developing small
molecule therapies for the treatment of cancer. Exelixis is focusing its
proprietary resources and development efforts exclusively on
cabozantinib. Exelixis has also established a portfolio of other novel
compounds that it believes have the potential to address serious unmet
medical needs, many of which are being advanced by partners as part of
collaborations. For more information, please visit the company's web
site at www.exelixis.com.
This press release contains forward-looking statements, including,
without limitation, statements related to: the clinical, therapeutic and
commercial potential of cabozantinib; and the expected timing for
top-line data from the COMET-1 pivotal trial. Words such as "planned,"
"continues," "anticipate," "believes," "potential," and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon Exelixis' current plans,
assumptions, beliefs and expectations. Forward-looking statements
involve risks and uncertainties. Exelixis' actual results and the timing
of events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties,
which include, without limitation: the availability of data at the
expected times; risks related to the potential failure of cabozantinib
to demonstrate safety and efficacy in clinical testing; the uncertain
timing and level of expenses associated with the development of
cabozantinib; Exelixis' ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; risks and
uncertainties related to Exelixis' compliance with applicable regulatory
requirements, including healthcare fraud and abuse laws and
post-marketing requirements; Exelixis' dependence on third-party
vendors; the sufficiency of Exelixis' capital and other resources;
market competition; changes in economic and business conditions. These
and other risk factors are discussed under "Risk Factors" and elsewhere
in Exelixis' annual report on Form 10-K filed with the Securities and
Exchange Commission (SEC (News - Alert)) on February 20, 2014 and in Exelixis' other
filings with the SEC. Exelixis expressly disclaims any duty, obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in
Exelixis' expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
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