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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 |
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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) |
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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. |
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