oben wieder etwas enger.
Exelixis Announces Positive Top-Line Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib versus Everolimus in Patients with Metastatic Renal Cell Carcinoma SOUTH SAN FRANCISCO, Calif., Jul 20, 2015 (BUSINESS WIRE) -- Exelixis, Inc. EXEL, +49.36% today announced positive top-line results from the primary analysis of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
The trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the everolimus arm (hazard ratio [HR]=0.58, 95 percent CI 0.45-0.75, p<0.0001).
Data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. A prespecified interim analysis, triggered by the primary analysis for PFS, showed a trend in OS favoring cabozantinib (HR = 0.67, unadjusted 95 percent CI 0.51 - 0.89; p=0.005). At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached.
Mit EXEL liege ich hier akt. um die 350 Prozent vorn. Das zieht, weil sich der Rest gut hält.
PP
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