Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-04-25

AUTHORS

Arinobu Tojo, Taiichi Kyo, Kazuhito Yamamoto, Hirohisa Nakamae, Naoto Takahashi, Yukio Kobayashi, Tetsuzo Tauchi, Shinichiro Okamoto, Koichi Miyamura, Kiyohiko Hatake, Hiromi Iwasaki, Itaru Matsumura, Noriko Usui, Tomoki Naoe, Meera Tugnait, Narayana I. Narasimhan, Stephanie Lustgarten, Heinrich Farin, Frank Haluska, Kazuma Ohyashiki

ABSTRACT

In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and Ph+ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. More... »

PAGES

385-397

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-017-2238-9

DOI

http://dx.doi.org/10.1007/s12185-017-2238-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085069121

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28444644


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380 rdf:type schema:Organization
381 grid-institutes:grid.470114.7 schema:alternateName Osaka City University Hospital, Osaka, Japan
382 schema:name Osaka City University Hospital, Osaka, Japan
383 rdf:type schema:Organization
 




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