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PACE and OPTIC Trials Focus on Ponatinib in Resistant Chronic-Phase CML

By: Vanessa A. Carter, BS
Posted: Thursday, January 7, 2021

At the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 647), Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported “high” response rates and “robust” survival outcomes with ponatinib in patients with chronic-phase chronic myeloid leukemia (CML). These patients from the PACE and OPTIC trials had failed to respond to second-generation tyrosine kinase inhibitors.

A total of 350 patients with chronic-phase CML from the PACE and OPTIC trials enrolled in the study. Patients from PACE received starting doses of 45, 30, or 15 mg/day of ponatinib; however, once BCR-ABL1IS levels dropped below 1%, the 45-mg and 30-mg groups were reduced to 15 mg/day. Data from OPTIC were from its interim analysis.

The proportion of individuals from the PACE and OPTIC studies who achieved BCR-ABL1IS levels below 1% at 12 months and 24 months were 42.0% and 47.3% and 45.5% and 51.6%, respectively. At 60 months, 47.1% of PACE participants had met the goal. Progression-free survival rates for PACE and OPTIC patients at 2 years were 67% and 81%, respectively. At 5 years, the rate for PACE participants was 52%. Overall survival rates for PACE and OPTIC participants at 2 years was 85% and 93%, respectively. The overall survival rate for PACE at 5 years was 73%. There were no data available at 5 years for OPTIC patients.

Serious treatment-emergent adverse events affected 63.4% and 31.2% of patients in the PACE and OPTIC groups, respectively; adjudicated arterial occlusive events affected 20.2% and 5.4%, respectively. Overall, the relative risk for adjudicated arterial occlusive events was 64% lower in OPTIC than in PACE.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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