Ponatinib: Additional Phase II data

Updated interim data from 392 evaluable patients in the single-arm, international, pivotal Phase II PACE trial showed that once-daily 45 mg oral ponatinib produced a MCyR rate of 47% in patients with chronic phase CML (n=248), with 39% of patients achieving a complete cytogenetic response (CCyR), at a median follow-up of 5.6 months. In 57 evaluable chronic phase CML patients with the T315I variant of BCR-ABL tyrosine kinase, ponatinib led to MCyR and CCyR rates of 65% and 58%, respectively. In 191 evaluable chronic phase CML patients without the T315I mutation, the MCyR rate was 41%.

In patients with accelerated phase CML (n=42) or blast phase CML or Ph+ ALL (n=46) in the resistant or intolerant cohort, ponatinib produced a major hematologic response rate of 74% and 37%, respectively. In the T315I-mutated cohort, major hematologic response rates were 46% in patients with accelerated phase CML (n=13) and 37% in patients with blast phase CML or Ph+ ALL (n=43). 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 Hematology meeting in San Diego. Ariad previously reported interim data from 159 evaluable patients (see BioCentury, Nov. 21). ...