Press Release
Press Release
Exelixis Announces Presentation of Updated Phase 2 Data for Cabozantinib in Men with Heavily-Pretreated Metastatic Castration-Resistant Prostate Cancer
-- Median Overall Survival of 10.8 months in a population where 73% of patients had 2+ prior therapies --
-- Responder analyses show that bone scan, circulating tumor cell, and pain responses are associated with longer overall survival --
“This clinical trial enrolled a heavily pretreated mCRPC population that has not been studied previously. These patients experienced disease progression despite treatment with docetaxel and additional therapies that included abiraterone, enzalutamide, or cabazitaxel. In this context the results are encouraging,” said Dr. Scher. “Patients with such advanced disease have limited options, and the data from this cohort suggest that cabozantinib has the potential to be an important treatment option for patients with mCRPC. The preliminary data suggest that these early response indicators are associated with longer median overall survival and warrant further prospective evaluation in phase 3. The ongoing phase 3 trials will help to define the potential utility of cabozantinib in mCRPC.”
The interim results presented today comprise data from 144 men with
mCRPC in the NRE cohort of an ongoing phase 2 randomized discontinuation
trial. All patients had disease progression in either bone or soft
tissue disease within 6 months of completion of docetaxel treatment, and
the protocol differed from typical CRPC studies in that it excluded
patients who progressed by
The median OS in the 144 patients was 10.8 months (95% confidence interval 9.1-13.0). Bone scan response (≥ 30% decrease from baseline in the Technetium-99m methylene diphosphonate bone scan lesion area determined by computer assisted detection) was observed in 65% of evaluable patients, CTC response (conversion from ≥ 5 CTC/7.5 mL of blood to < 5 CTC/7.5 mL of blood) in 32% of evaluable patients, and pain response (≥ 30% decrease from baseline in worst pain observed at 2 consecutive assessments ≥ 6 weeks apart) in 43% of evaluable patients. In univariate analyses, longer OS was associated with bone scan response at week 6, CTC response at week 6, and pain response. These findings were further examined and confirmed in sensitivity analyses after adjusting for significant baseline covariates, such as LDH, presence or absence of visceral metastasis, and bone scan lesion area (bone disease burden), which were selected from a stepwise Cox regression model.
Safety data for the NRE were presented at two medical meetings in 2012.
At the ASCO Annual Meeting in
“These data provide additional evidence that cabozantinib has clinical
activity against multiple aspects of metastatic disease in this patient
population,” said
About Cabozantinib
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
by the
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.
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 belief that the referenced post hoc findings
support the rationale for potential future prospective validation of the
association of bone scan response with OS in the ongoing phase 3 COMET
trials; the belief that the referenced data is encouraging; the
potential for cabozantinib to be an important treatment option for
patients with mCRPC; the belief that the ongoing phase 3 COMET trials
will help define the potential utility of cabozantinib in mCRPC; the
correlation of the NRE cohort and the referenced data with the ongoing
phase 3 COMET trials; and Exelixis’ clinical strategy in mCRPC. Words
such as “show,” “support,” “rationale,” “potential,” “future,”
prospective,” “validation,” “encouraging,” “suggest,” “option,”
“warrant,” “provide,” “evidence,” “being,” “believe,” “continued,”
“strategy,” 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