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Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial

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Abstract

Bosutinib is approved in the United States, Europe, Japan, and other countries for treatment of newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML), and CML resistant/intolerant to prior therapy. In the phase 3 BFORE trial (Clinicaltrials.gov, NCT02130557), patients were randomized 1:1 to first-line bosutinib or imatinib 400 mg once daily. We examined efficacy, safety, and patient-reported outcomes of bosutinib vs imatinib and pharmacokinetics of bosutinib in the Asian (n = 33 vs 34) and non-Asian (n = 235 vs 234) subpopulations of BFORE followed for at least 24 months. At the data cutoff date, 72.7 vs 66.7% of Asian and 70.6 vs 66.4% of non-Asian patients remained on treatment. The major molecular response rate at 24 months favored bosutinib vs imatinib among Asian (63.6 vs 38.2%) and non-Asian (60.9 vs 52.6%) patients, as did the complete cytogenetic response rate by 24 months (86.7 vs 76.7%, 81.5 vs 76.3%). Treatment-emergent adverse events in both subpopulations were consistent with the primary BFORE results. Trough bosutinib concentration levels tended to be higher in Asian patients. Health-related quality of life was maintained after 12 months of bosutinib in both subpopulations. These results support bosutinib as a first-line treatment option in Asian patients with CP CML.

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Acknowledgements

The authors would like to thank Dong-Wook Kim for his contributions to the provision of study materials/patients and the collection and assembly of data. This study was sponsored by Pfizer. Medical writing support was provided by Emily Balevich, PhD, of Engage Scientific Solutions and was funded by Pfizer.

Author information

Authors and Affiliations

  1. Singapore General Hospital, Duke-NUS Medical School, 20 College Road, Singapore, 169856, Singapore

    Charles Chuah

  2. National University Cancer Institute, Singapore, Singapore

    Liang Piu Koh

  3. Phramongkutklao Hospital, Phramongkutklao College of Medicine, Bangkok, Thailand

    Tontanai Numbenjapon

  4. Hallym University Sacred Heart Hospital, Anyang, Republic of Korea

    Dae Young Zang

  5. Tan Tock Seng Hospital, Singapore, Singapore

    Kiat Hoe Ong

  6. Dongsan Medical Center, Keimyung University, Daegu, Republic of Korea

    Young Rok Do

  7. Pfizer R&D Japan GK, Tokyo, Japan

    Masayuki Ohkura

  8. Pfizer Japan Inc, Tokyo, Japan

    Chiho Ono

  9. Pfizer SLU, Madrid, Spain

    Andrea Viqueira

  10. Georgia Cancer Center at Augusta University, Augusta, GA, USA

    Jorge E. Cortes

  11. Universitätsklinikum RWTH Aachen, Aachen, Germany

    Tim H. Brümmendorf

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Correspondence to Charles Chuah.

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Conflict of interest

Charles Chuah has received research funding from Bristol-Myers Squibb and honoraria from Bristol-Myers Squibb, Novartis, Korea Otsuka Pharmaceuticals and Chiltern International. Kiat Hoe Ong served on advisory boards for Abbvie, AstraZeneca, Johnson & Johnson, and Novartis; received speaker fees from Johnson & Johnson and Novartis; and received conference registration/travel accommodations from Amgen, Bristol-Myers Squib, and Celgene. Young Rok Do served as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Ilynag Pharma. Masayuki Ohkura and Chiho Ono are employees of Pfizer. Andrea Viqueira is an employee of and owns stock in Pfizer. Jorge E. Cortes has received research funding from Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Sun Pharma and served as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Fusion Pharma. Tim H. Brümmendorf has received research funding from Novartis and Pfizer and participated in advisory boards and/or satellite symposia for Ariad, Bristol-Myers Squibb, Janssen, Merck, Novartis, and Pfizer. Liang Piu Koh, Tontanai Numbenjapon, and Dae Young Zang declare that they have no conflicts of interest.

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Chuah, C., Koh, L.P., Numbenjapon, T. et al. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol 114, 65–78 (2021). https://doi.org/10.1007/s12185-021-03144-4

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  • DOI: https://doi.org/10.1007/s12185-021-03144-4

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