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news.ARIAD Pharmaceuticals (ARIA) announced that the first patient has been treated in its OPTIC (Optimizing Ponatinib Treatment In CML) trial of Iclusig (ponatinib).
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This randomized, dose-ranging trial is designed to evaluate three starting doses of ponatinib in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML) and is expected to inform the optimal use of Iclusig in these patients. Approximately 450 patients will be enrolled at clinical sites around the world.
"Ongoing analyses of dose reductions among patients enrolled in the Phase 1 trial and Phase 2 PACE trial of ponatinib have shown sustained responses among patients whose ponatinib dosages were reduced," stated Jorge E. Cortes, M.D., Professor and Deputy Chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center.
"The trial will provide randomized clinical data on the benefit and risk of initiating this treatment at lower doses. It is hoped that it will help us make treatment decisions for patients with CML who have become resistant to other tyrosine-kinase inhibitors (TKIs)."
This study will enroll patients with CP-CML who are resistant to at least two approved TKIs. These patients will be randomized equally to receive once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or 15 mg (cohort C) of ponatinib. Patients in cohorts A and B will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR).
The primary endpoint of the trial is MCyR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each dose cohort, rates of adverse events and rates of serious adverse events.
Other secondary endpoints include cytogenetic, molecular and hematologic response rates, tolerability, duration of response, time to response, disease control rate, progression-free survival and overall survival. Preliminary data from the OPTIC trial is expected at the end of 2016.
"The OPTIC trial is expected to provide important data regarding the efficacy and safety of starting doses of ponatinib lower than the currently approved dose of 45 mg/day," said Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD.
"The trial will give us the opportunity to prospectively evaluate strategies for dose reductions after patients have achieved a major cytogenetic response, with a goal of minimizing risk, while helping to maintain patients on a lower dose and to optimize therapy."