Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

Summary

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

Timeline

Start

2012-06

Primary completion

2013-10

Completion

2013-10

Outcome

Missed primary endpoint

Stopped: “Study terminated based on evaluation of safety data.”

registry Ponatinib vs Imatinib; p = 0.074; Cochran-Mantel-Haenszel NCT01650805 ↗

paper did not differ significantly between the two groups (eight [80%] of ten patients given ponatinib and five [38%] of 13 patients given imatinib; p=0·074). PMID 27083332 ↗

Publications

• Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2022 Apr;62(4):555-567. doi: 10.1002/jcph.1990. Epub 2021 Dec 16.
• Lipton JH, Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Assouline S, Etienne G, Nicolini FE, le Coutre P, Clark RE, Stenke L, Andorsky D, Oehler V, Lustgarten S, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian HM, Shah NP, Talpaz M, Deininger MW; EPIC investigators. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2016 May;17(5):612-21. doi: 10.1016/S1470-2045(16)00080-2. Epub 2016 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Imatinib	Small molecule	400 mg	Oral
Subject	Ponatinib	Small molecule	45 mg	Oral

Indications