Abstract
This long-term follow-up of a completed phase 1/2 study assessed the safety and efficacy of bosutinib in Japanese Philadelphia chromosome-positive, chronic phase (CP) or advanced phase (ADV) chronic myeloid leukemia patients who were resistant/refractory or intolerant to prior tyrosine kinase inhibitor treatment. This analysis included 63 patients with a median bosutinib follow-up of 132 weeks (range 3‒372). In the CP second-line (2L) cohort, the cumulative major cytogenetic response (MCyR) and major molecular response (MMR) rates throughout the study were 73 and 53%, respectively. In the CP third-line (3L) cohort, the cumulative MCyR and MMR rates throughout the study were 70 and 40%, respectively. Of the eight ADV patients, MCyR was attained or maintained by 50% of patients, and complete hematologic response was attained or maintained by 25% of patients. Progression-free survival rate and overall survival rate at 96 weeks were, respectively, 91 and 98% in CP2L, 88 and 100% in CP3L, and 33 and 50% in ADV patients. The most common adverse events (>50%) reported were diarrhea (95%), nasopharyngitis (57%), and rash (57%). Bosutinib demonstrated durable efficacy and a manageable tolerability profile over long-term use in Japanese patients.
ClinicalTrials.gov: NCT00811070.
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Acknowledgements
This study was sponsored by Pfizer Inc. The authors thank Emiko Ohki and Hiroko Godai, of Pfizer Inc, for their contributions. Editorial support was provided by Anny Wu, PharmD, of Complete Healthcare Communications, LLC, and was funded by Pfizer Inc.
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Dr. Takahashi reports grants and personal fees from Pfizer and Novartis and grants from Otsuka Pharmaceutical during the conduct of the study. Dr. Nakaseko reports grants and personal fees from Pfizer and Bristol-Myers Squibb during the conduct of the study. Dr. Kobayashi reports grants from Pfizer, Astellas Pharma, Amgen Astellas BioPharma, Otsuka Pharmaceuticals, and Ariad Pharmaceuticals during the conduct of the study. Drs. Ono, Koide, and Fujii are employees of Pfizer Japan. Drs. Miyamura and Ohnishi have nothing to disclose.
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Takahashi, N., Nakaseko, C., Kobayashi, Y. et al. Long-term treatment with bosutinib in a phase 1/2 study in Japanese chronic myeloid leukemia patients resistant/intolerant to prior tyrosine kinase inhibitor treatment. Int J Hematol 106, 398–410 (2017). https://doi.org/10.1007/s12185-017-2239-8
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DOI: https://doi.org/10.1007/s12185-017-2239-8