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“RCC patients who progressed after or who are refractory to initial
treatment with VEGFR-TKI therapy have limited treatment options,” said
METEOR Principal Investigator
METEOR is an open-label trial of cabozantinib in patients with mRCC that
is being conducted at up to 200 sites in up to 26 countries. The trial
is expected to enroll 650 patients with clear cell RCC who have received
and progressed on at least one VEGFR-TKI. Patient enrollment will be
The primary endpoint is progression-free survival (PFS) and the secondary endpoint is overall survival (OS). Exploratory endpoints include patient-reported outcomes, biomarkers, safety, and pharmacokinetics. PFS is an established acceptable endpoint for RCC clinical trials and has been used to support approval of sorafenib, sunitinib, everolimus, axitinib, and pazopanib in this indication.
Based on available clinical trial data, the primary endpoint assumes a median PFS of 5 months for the everolimus arm and 7.5 months for cabozantinib arm. This provides for a hazard ratio (HR) of 0.67 and 90% power and requires 259 PFS events among the first 375 patients randomized. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. This provides for a HR of 0.75 and 80% power and requires 413 events.
“Initiation of this phase 3 pivotal trial in mRCC is an important
component of our development strategy to expand the cabozantinib
franchise by exploring additional indications with the goal of providing
patients with new treatment options,” said
Cabozantinib inhibits the activity of tyrosine kinases including RET,
MET and VEGFR2. 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
COMETRIQ™ Important Safety Information, including Boxed Warning
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 (PPE) Syndrome 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.
- 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.
Drug Interactions – COMETRIQ is a CYP3A4 substrate. Co-administration of strong CYP3A4 inhibitors can increase cabozantinib exposure. Chronic co-administration of strong CYP3A4 inducers can reduce cabozantinib exposure.
For full prescribing information, including Boxed Warning, please visit www.COMETRIQ.com.
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 belief that the cabozantinib data to date in RCC
patients previously treated with VEGFR-TKIs provide a sound rationale
for the design of the METEOR trial; the design, plans and goals for the
METEOR trial, and the potential success thereof; Exelixis’ development
strategy to expand the cabozantinib franchise; Exelixis’ plans to
explore cabozantinib in additional indications; Exelixis’ goal of
providing patients with new treatment options; and Exelixis’ plan to
begin a phase 3 pivotal trial of cabozantinib in metastatic
hepatocellular carcinoma and the expected timing thereof. Words such as
“endpoint,” “encouraging,” “provide,” “rationale,” “design,”
“conducted,” “expected,” “will,” “assumes,” “strategy,” “expand,”
“exploring,” “goal,” “new,” “options,” “intended,” “potential,” “on
track,” and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
Charles Butler, 650-837-7277
Vice President, Investor Relations and Corporate Communications