BioCentury
ARTICLE | Clinical News

Iclusig ponatinib: Preliminary Phase III data

June 9, 2014 7:00 AM UTC

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 imatinib. Iclusig led to a CCyR in 74% of patients (n=54) at any time vs. 53% for imatinib (n=64; p=0.019). At 6 months, CCyR rate was 86% for Iclusig (n=36) vs. 60% for imatinib (n=50; p=0.012). Additionally, Iclusig increased the proportion of patients with 4 and 4.5 log reductions in BCR-ABL levels at all time points through month 12 vs. imatinib (p<0.02). More adverse events were observed in the Iclusig arm vs. imatinib, including vascular occlusive events (8% vs. 2%); lipases increase (14% vs. 2%); thrombocytopenia (12% vs. 7%) and rash (7% vs. 1%). Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...