BioCentury
ARTICLE | Clinical News

Ponatinib: Additional Phase II data

June 11, 2012 7:00 AM UTC

Updated data from 444 evaluable patients in the single-arm, international, pivotal Phase II PACE trial showed that once-daily 45 mg oral ponatinib produced an MCyR rate of 54% in patients with chronic phase CML (n=267), with 44% of patients achieving a complete cytogenetic response (CCyR) and 37% achieving a major molecular response (MMR). Median follow-up was 10.1 months. MMR is the primary endpoint in Ariad's Phase III trial evaluating ponatinib vs. imatinib that is slated to begin next quarter.

In patients who previously received only 1 tyrosine kinase inhibitor (n=21), 86% achieved an MCyR. In 64 evaluable chronic phase CML patients with the T315I variant of BCR-ABL tyrosine kinase, ponatinib led to an MMR rate of 50%, an MCyR rate of 70% and a CCyR rate of 66%. In 203 evaluable chronic phase CML patients without the T315I mutation, the MCyR rate was 49%. In patients with accelerated phase CML (n=65) or blast phase CML or Ph+ ALL (n=48) in the resistant or intolerant cohort, ponatinib produced a major hematologic response rate of 60% and 35%, respectively. In the T315I-mutated cohort, major hematologic response rates were 50% in patients with accelerated phase CML (n=18) and 33% in patients with blast phase CML or Ph+ ALL (n=46). The MCyR and CCyR rate was 34% and 20% in accelerated phase patients, respectively, and 27% and 23% in patients with blast phase CML or Ph+ ALL patients. Pancreatitis occurred in 6% of patients. The trial enrolled 449 patients who are resistant or intolerant to dasatinib or nilotinib or with the T315l variant of BCR-ABL tyrosine kinase. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Ariad previously reported interim data from 392 evaluable patients (see BioCentury, Dec. 19, 2011). ...