ARIAD Pharma Announces Initiation Of Randomized Phase 3 Trial Of Iclusig

(RTTNews) - ARIAD Pharmaceuticals Inc. (ARIA) announced the initiation of a randomized Phase 3 trial of Iclusig or ponatinib in second-line patients with chronic myeloid leukemia or CML in the chronic phase or CP.

The OPTIC-2L (Optimizing Ponatinib Treatment In CML, Second Line) trial is designed to investigate the efficacy and safety of ponatinib, administered at two starting doses, compared with nilotinib, in patients who are resistant to front-line treatment with imatinib.

The primary endpoint of the OPTIC-2L study, now open for patient enrollment, is major molecular response (MMR) by 12 months. Approximately 600 patients are expected to be enrolled at clinical sites in Europe, Asia, Latin America and Canada.

This study is designed to demonstrate superiority of ponatinib over nilotinib and will enroll patients with CP-CML who have become resistant to imatinib and have received no other tyrosine kinase inhibitor. These patients will be randomized to receive once-daily administration of ponatinib at a starting dose of either 30 mg (cohort A) or 15 mg (cohort B), or 400 mg of nilotinib administered twice daily (cohort C). Patients will be randomized in a ratio of 1:2:1 respectively.

Upon reaching MMR, patients in cohort A will have their daily dose of ponatinib reduced to 15 mg and patients in cohort B will have their dose reduced to 10 mg.

The primary endpoint of the trial is MMR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each cohort, rates of adverse events and rates of serious adverse events.

Patients will be enrolled at up to 90 cancer centers in Europe, Asia, Latin America and Canada.