ARIAD Reports Long-Term Safety & Efficacy Data Of Ponatinib From Phase 1 Study

(RTTNews) - ARIAD Pharmaceuticals, Inc. (ARIA) announced long-term follow up data from the Phase 1 trial of Iclusig or ponatinib, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or CML or Philadelphia chromosome-positive acute lymphoblastic leukemia. The trial demonstrates that with a median follow-up of four years in chronic phase CML patients, Iclusig continues to show anti-leukemic activity in patients with limited treatment options and that responses have been maintained in CP-CML patients with 72 percent having a major cytogenetic response, 65 percent having a complete cytogenetic response (CCyR) and 56 percent having a major molecular response (MMR).

The long-term safety data show that careful benefit-risk evaluations should guide decisions to use and maintain ponatinib therapy, mainly in patients who may be at increased risk for arterial thrombotic events.

The Phase 1 dose-escalation study of ponatinib enrolled 81 patients with resistant or refractory hematologic cancers, comprising 43 patients with chronic-phase CML. The company said 60% of CP-CML patients in this study had failed at least three prior tyrosine kinase inhibitors (TKI), and more than 90% received at least two prior TKIs. Twenty-two CP-CML patients remain on study.