A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

Summary

The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. The efficacy of HQP1351 is determined by evaluating the subjects' event free survival (EFS).

Timeline

Start

2019-10-21

Primary completion

2024-08-01

Completion

2024-08-01

Outcome

Met primary endpoint

release “patients with CML-CP resistant/intolerant to prior treatment with TKIs, the olverembatinib arm, compared with the BAT arm, achieved statistically significant improvement in event-free survival (EFS)” ascentage.com ↗

release “therefore meeting the primary endpoint of the study.” ascentage.com ↗

release “Olverembatinib demonstrated clear therapeutic advantage over the BAT arm in patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs.” ascentage.com ↗

Publications

• Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Homoharringtonine	Small molecule	—	—
Comparator	Hydroxyurea	Other / unclassified	—	—
Comparator	Imatinib	Small molecule	—	—
Comparator	Nilotinib	Small molecule	—	—
Subject	Olverembatinib	Small molecule	40 mg	Oral
Comparator	dasatinib anhydrous	Small molecule	—	—

Indications