30May

Independent review: Arterial occlusive events due to ponatinib in PACE trial Ph+ CML

An independent review of arterial occlusive events (AOEs) in the ponatinib (PON) phase II PACE trial (NCT01207440) in patients (pts) with Ph+ leukemia.


Abstract No : 7550

Abstract Type : Poster Discussion Session

Indication : Chronic Myeloid Leukemia (CML)

Intervention : Ponatinib

Company : ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Technology : Small molecule


Results:

The PACE review included 449 heavily pretreated pts with Ph+ leukemia (median age, 59 y; 47% female; 93% ≥2 tyrosine kinase inhibitors). With median follow-up 37.3 mo in all pts, AOEs were identified by MedDRA PT search in 25% of pts and EAC-verified in 17% (Table). In each category listed in the table, the EAC verification identified fewer AOEs and serious AOEs. Serious AOEs were identified by MedDRA PT search in 20% of pts and EAC-verified in 16%. Events that were not associated with a cardiovascular etiology or failed to meet the MACE definition set forth by the ACC/AHA were determined by the EAC not to be an AOE


Conclusion:

The independent EAC review showed a lower rate of clinically relevant AOEs than was reported in PACE, suggesting an earlier possible overestimation that may not accurately reflect the risk of AOEs with PON. The ongoing PON dose-ranging OPTIC study will further evaluate the PON risk:benefit profile.


Commentary:

Data provides contextual insights regarding safety profile of Ponatinib, further assessment ongoing in OPTIC study.


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