Ariad Reveals Ponatinib's Long-Term Safety And Efficacy Data From Stage 2 Clinical Study

ARIAD Pharmaceuticals, Inc. ARIA revealed long-term follow-up data from its pivotal Phase 2 PACE clinical study of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). According to the company, responses were maintained long-term in chronic phase CML (CP-CML) patients.

ARIAD said the trial showed that patients treated with Iclusig continued to demonstrate anti-leukemic activity with a median follow-up of 4.0 years for CP-CML. Additionally, 96 percent of CP-CML patients who underwent ponatinib dose reductions while in response maintained their responses (MCyR) at the four year timepoint.

Professor and deputy chair, department of leukemia, University of Texas MD Anderson Cancer Center, Jorgoe Cortes, said, "We remain very pleased by these continued responses in the PACE study in such a heavily pretreated patient population, as 59 percent of patients had previously received three or more approved tyrosine kinase inhibitors (TKIs). Altogether, 82 percent of CP-CML patients who achieved MCyR are estimated to remain in MCyR at four years."

He added, "These data showing long-term major cytogenic response offer the optimism of favorable outcomes for many patients who previously had no or very limited treatment options available."

The company indicated that data were featured at the 21st Conference of the European Hematology Association (EHA) in Copenhagen, Denmark.

The stock traded 1.57 percent down on Monday.