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ASCO 2020: Early Results of Ponatinib Dose-Range Study in CML

By: Sarah Campen, PharmD
Posted: Thursday, June 4, 2020

Initial data from the OPTIC trial—a phase II study evaluating a range of ponatinib doses in heavily pretreated patients with chronic myeloid leukemia (CML) following the discovery of higher rates of arterial occlusive events associated with ponatinib—indicate a dose-dependent trend toward efficacy and safety. Additionally, some patients in the higher dosing cohorts were able to decrease to 15 mg of ponatinib daily after achievement of ≤ 1% BCR-ABL1IS. The interim analysis results were presented during the ASCO20 Virtual Scientific Program (Abstract 7502).

The OPTIC trial “may provide a refined understanding of the ponatinib benefit-risk profile and its relation to dose,” stated Jorge E. Cortes, MD, Director of the Georgia Cancer Center at Augusta University, and colleagues.

The ongoing study enrolled 283 patients with CML in chronic phase with a T315I mutation or who were resistant or intolerant to two or more tyrosine kinase inhibitors. Patients were randomly assigned to receive ponatinib at a starting daily dose of 45 mg (n = 94), 30 mg (n = 95), or 15 mg (n = 94); for patients in the 45-mg and 30-mg cohorts, doses were reduced to 15 mg daily after achievement of ≤ 1% BCR-ABL1IS.

At the interim data cutoff, 162 patients (57%) remained on the study treatment. At 12 months, 39%, 27%, and 26% of patients in the 45-mg, 30-mg, and 15-mg cohorts had achieved ≤ 1% BCR-ABL1IS, respectively. In the 45-mg and 30-mg cohorts, 35% and 21% of patients were able to reduce the dose to 15 mg due to efficacy.

As for safety, the most common any-grade treatment-emergent adverse event included thrombocytopenia (39%) and neutropenia (25%). Arterial occlusive events were reported in 5%, 4%, and 1% in the 45-mg, 30-mg, and 15-mg cohorts, respectively.

Disclosure: For full disclosures of the authors, visit coi.asco.org.



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