Press Release
Press Release
Exelixis Initiates Randomized Phase 2 Clinical Trial of Cabozantinib Plus Abiraterone in Chemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate Cancer
“A growing body of data support the potential clinical utility of
cabozantinib in treating patients with metastatic CRPC,” said
The phase 2 trial will compare abiraterone/prednisone against
abiraterone/prednisone in combination with one of the three cabozantinib
doses: 40 mg daily, 20 mg daily, or 20 mg every other day. The trial is
expected to enroll 280 chemotherapy-naïve CRPC patients who have bone
metastases, and will be conducted at approximately 50 sites in
“With its differentiated mechanism targeting MET, RET, and VEGFR2, we
believe cabozantinib has the potential to be therapeutically
complementary with prostate cancer therapies such as abiraterone and
enzalutamide,” said
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including MET,
RET 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
by the
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 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.
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.
About
Forward-Looking Statements
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 potential clinical utility of cabozantinib in
treating patients with metastatic CRPC; the potential for cabozantinib
as a new treatment option for CRPC patients who have bone metastases but
have not yet received chemotherapy; the belief that continued study of
cabozantinib in a variety of CRPC indications may help to advance the
treatment of the disease; the belief that cabozantinib has the potential
to be therapeutically complementary with prostate cancer therapies such
as abiraterone and enzalutamide; plans to initiate a phase 1 clinical
trial of cabozantinib in combination with enzalutamide and the expected
timing thereof; the belief that the referenced phase 2 and phase 1
trials of cabozantinib should support Exelixis’ efforts to realize the
full clinical and commercial potential of cabozantinib in CRPC; and the
design, plans and goals for the referenced phase 2 trial of
cabozantinib, and the potential success thereof. Words such as
“endpoint,” “support,” “potential,” “utility,” “can,” “opening the
door,” “new,” “continued,” “may,” “will,” “expected,” “believe,”
“provide,” “might,” “should,” “efforts,” “realize,” and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon
Source:
Exelixis, Inc.
Charles Butler, 650-837-7277
Vice President,
Investor Relations and Corporate Communications
cbutler@exelixis.com