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Jun 09, 2014
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Iclusig ponatinib: Preliminary Phase III data

Preliminary data from the discontinued confirmatory Phase III EPIC trial in 307 newly diagnosed leukemia patients showed that a higher proportion of patients receiving Iclusig achieved <10% BCR-ABL transcript level at 3 months vs. imatinib (94% vs. 68%, p<0.001). Ariad said the measure has been shown in other trials to correlate with OS. Median follow-up was 5 months at the time of termination. Although the primary endpoint could not be assessed due to early termination, the 12-month MMR rate was 80% in evaluable Iclusig-treated patients (n=10) vs. 39% in evaluable imatinib-treated patients (n=13; p=0.074). Additionally, Iclusig increased MMR rates at 3 months (31% vs. 3%), 6 months (62% vs. 22%) and 9 months (86% vs. 33%) vs. imatinib (p=0.001 for all).

Median time to MMR was 100 days in patients receiving Iclusig vs. 169 days for...

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