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Conference Call on
The COMET-1 results are the subject of ongoing analyses.
As a result of the outcome of COMET-1,
“We are very disappointed that COMET-1 did not meet its primary endpoint
of extending overall survival in men with mCRPC,” said Michael M.
Morrissey, Ph.D., president and chief executive officer of
Dr. Morrissey continued, “We have thoughtfully prepared for this
scenario and the resulting very difficult decisions. The workforce
reduction we have announced today is necessary to significantly reduce
our corporate operating expenses. I would like to personally express my
deep appreciation to the talented and dedicated
Based on the outcome of COMET-1,
Investor Conference Call and Webcast
An archived replay of the conference call will be available on the Event
Calendar page under Investors & Media at www.exelixis.com
and via phone until
About the COMET-1 Phase 3 Pivotal Trial
COMET-1 was a randomized, double-blind, controlled trial that enrolled 960 patients with mCRPC who had previously been treated with and progressed after treatment with docetaxel, abiraterone and/or enzalutamide. The primary endpoint of the trial was OS, and the secondary endpoint was bone scan response as assessed by an independent radiology committee. All patients in the trial had bone metastases, and there was 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 was event-driven and had 90% power to detect a 25% reduction in the risk of death (HR = 0.75) at the time of final analysis, which required 578 events.
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 tumor microenvironment.
COMETRIQ® (cabozantinib) is currently approved by the
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 patients.
- COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.
- Wound complications have been reported with COMETRIQ.
- COMETRIQ treatment results in an increase in hypertension.
- Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.
- 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 with COMETRIQ.
- 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, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf
Please refer to the full European Summary of Product Characteristics for
This press release contains forward-looking statements, including,
without limitation, statements related to: the continued development and
clinical, therapeutic and commercial potential of, and opportunities
for, cabozantinib; the results and implications of completed, partial,
and ongoing clinical data analyses; future data presentations; future
discussions with regulatory authorities; anticipated developments and
timing with respect to Exelixis’ ongoing phase 3 pivotal trials of
cabozantinib; plans to focus financial resources, to halt
company-sponsored studies in mCRPC; and plans to initiate a workforce
reduction, including the objectives and anticipated timing thereof.
Words such as “will,” “enable,” “focus,” “anticipates,” “expect,”
“ensure,” “potential,” or other similar expressions, identify
forward-looking statements, but the absence of these words does not
necessarily mean that a statement is not forward-looking. In addition,
any statements that refer to expectations, projections or other
characterizations of future events or circumstances are forward-looking
statements. These forward-looking statements are based upon Exelixis’
current plans, assumptions, beliefs, expectations, estimates and
projections. Forward-looking statements involve risks and uncertainties.
Exelixis’ actual results and the timing of events could differ
materially from those anticipated in the 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 study; the clinical, therapeutic and commercial
value of cabozantinib; Exelixis’ ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; risks and
uncertainties related to regulatory review and approval processes and
Exelixis’ compliance with applicable legal and regulatory requirements;
the general sufficiency of Exelixis’ capital and other resources and the
specific risk of unforeseen expenses that could diminish Exelixis’
financial ability to support its operations through the release of
top-line METEOR results; the uncertain timing and level of expenses
associated with the development of cabozantinib; risks related to
Exelixis’ ability to implement the referenced workforce reduction
according to plan and its impact on Exelixis’ business; expenses and
charges resulting from the referenced workforce reduction; market
competition; changes in economic and business conditions; and other
factors discussed under the caption “Risk Factors” in Exelixis’
quarterly report on Form 10-Q filed with the