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news.Sanofi-Aventis has announced positive results of a randomized Phase III study in adult patients with hematological malignancies at high or potential risk for tumor lysis syndrome which demonstrated that Elitek significantly reduced plasma uric acid levels compared to allopurinol alone.
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The study also compared a sequential combination of the two agents versus allopurinol alone, which showed a reduction in plasma uric acid levels for the sequential combination versus allopurinol alone (p=0.06).
The primary objective of the multi-center, open-label, randomized, parallel group comparative study was to compare the adequacy of control of plasma uric acid (PUA) concentration and the safety profile in three treatment arms. Among the three treatment arms, plasma uric acid response rate was 87% of patients treated with Elitek compared to 66% receiving allopurinol alone (p=0.001) and 78% with Elitek/allopurinol (p=0.06).
Among patients at high risk for tumor lysis syndrome, the PUA response rate was 89% with Elitek versus 68% with allopurinol and 79% with the Elitek/allopurinol combination (p=0.0012). The PUA response rate among patients with baseline hyperuricemia defined as plasma uric acid >7.5mg/dL was 90% with Elitek versus 53% with allopurinol and 77% with Elitek/allopurinol (p=0.0151).
The time to control, or normalize, PUA in hyperuricemic patients was 4.1 hours among patients treated with Elitek (n=18 [95% CI=4.0 to 4.5]), 4.1 hours with the Elitek/allopurinol combination (n=12 [95% CI=3.9 to 4.5) and 27 hours in the allopurinol alone arm (n=17 [95% CI=4.0 to 49.0]). These study results will form the basis for a supplemental new drug application submission to the FDA.
Jorge Cortes, principal investigator of the study, said: In this investigational study, Elitek controlled plasma uric acid in a larger percentage of patients and in a shorter period of time than allopurinol, the current US standard treatment in adults.