Saturday, December 29, 2012

Meet the newly approved RET/MET/VEGFR inhibitorFromExelixis  

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HAVE WE MET? -- NEW COMETRIQ ™ (cabozantinib)
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COMETRIQ is indicated for the treatment of patients with progressive,
metastatic medullary thyroid cancer (MTC).
COMETRIQ inhibits the activity of tyrosine kinases including RET, MET, and VEGFRs. 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 demonstrated significant efficacy in a phase 3 trial (N=330) in metastatic MTC patients with radiographically confirmed disease progression.*
Significantly prolonged progression-free survival (PFS) vs placebo (HR=0.28; 95% CI: 0.19, 0.40; P<0.0001)
— Median PFS was 11.2 months with COMETRIQ vs 4.0 months with placebo
Objective response rate (ORR) was 27% with COMETRIQ vs 0% with placebo (P<0.0001)
— Median duration of tumor response was 14.7 months (95% CI: 11.1, 19.3)
Adverse reactions occurring in ≥25% of patients treated with COMETRIQ and more frequently than with placebo (≥5% between-arm difference) in order of decreasing frequency were: diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome, decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation; the most common laboratory abnormalities (>25%) were increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.
* Results of the international, multicenter, randomized, double-blind EXAM study in patients (N=330) with progressive, metastatic MTC. Primary endpoint: PFS; secondary endpoints: ORR and overall survival (OS). OS data are not yet mature.
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