Press Release
Press Release
Exelixis Completes Enrollment of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Metastatic Renal Cell Carcinoma
-- Top-Line Data from METEOR Expected in Q2 2015 --
-- Primary Analysis of PFS Endpoint to Be Conducted on First 375 Patients Enrolled --
“METEOR was designed to evaluate cabozantinib’s potential as a treatment
for metastatic renal cell carcinoma, an aggressive form of the disease
that is usually incurable,” said
About METEOR
METEOR is an open-label, event-driven trial with the primary endpoint of
progression-free survival (PFS). The trial is being conducted at up to
200 sites in up to 26 countries, and enrollment has been weighted toward
Based on available clinical trial data, the primary endpoint of METEOR
assumes a median PFS of 5 months for the everolimus arm and 7.5 months
for the cabozantinib arm. The trial protocol specifies that the primary
analysis will be conducted on the first 375 patients enrolled, and will
be triggered after at least 259 events occur, providing 90% power to
detect a hazard ratio (HR) of 0.67. Enrollment of the first 375 patients
was completed in
Secondary endpoints for METEOR include overall survival and objective response rate. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. The study was designed to observe 408 deaths in the entire intention-to-treat population, providing 80% power to detect a HR of 0.75.
About Cabozantinib
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
full
About
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: expected timing of future
data results with respect to Exelixis’ ongoing phase 3 pivotal trial of
cabozantinib in patients with metastatic RCC and the continued
development and clinical, therapeutic and commercial potential of
cabozantinib. Words such as “expected,” “potential,” “look forward,” 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
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 testing; the clinical, therapeutic and
commercial value of cabozantinib; 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 results from
METEOR; the uncertain timing and level of expenses associated with the
development of cabozantinib; risks related to Exelixis’ ability to
implement its previously-announced workforce reduction according to plan
and its impact on Exelixis’ business; charges, expenses and cash
expenditures 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
Source:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor
Relations and Corporate Communications
shubbard@exelixis.com