Bosutinib versus imatinib in newly diagnosed chronic‐phase chronic myeloid leukaemia: results from the 24‐month follow‐up of the BELA trial |
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Authors: | Tim H Brümmendorf Jorge E Cortes Cármino Antonio de Souza Francois Guilhot Ladan Duvillié Dmitri Pavlov Karïn Gogat Athena M Countouriotis Carlo Gambacorti‐Passerini |
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Institution: | 1. Universit?tsklinikum Aachen, RWTH Aachen, Aachen, Germany;2. Universit?tsklinikum Hamburg‐Eppendorf, Hamburg, Germany;3. The University of Texas MD Anderson Cancer Center, Houston, TX, USA;4. University of Campinas, Campinas, SP, Brazil;5. Inserm CIC 1402, CHU de Poitiers, Poitiers, France;6. Pfizer Global Research and Development, Paris, France;7. Pfizer, New York, NY, USA;8. Pfizer, La Jolla, CA, USA;9. University of Milano‐Bicocca, Monza, Italy |
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Abstract: | Bosutinib is an oral, dual SRC/ABL1 tyrosine kinase inhibitor for resistant/intolerant chronic myeloid leukaemia (CML). We assessed the efficacy and safety of bosutinib 500 mg/d (n = 250) versus imatinib 400 mg/d (n = 252) after >24 months from accrual completion in newly diagnosed chronic phase (CP)‐CML (Bosutinib Efficacy and Safety in Newly Diagnosed CML trial BELA]). Cumulative complete cytogenetic response (CCyR) rates by 24 months were similar (bosutinib, 79%; imatinib, 80%); cumulative major molecular response (MMR) rates were 59% for bosutinib and 49% for imatinib. Responses were durable; 151/197 vs. 172/204 and 125/153 vs. 117/131 responders remained on treatment and maintained CCyR and MMR, respectively. Since the 12‐month primary analysis, no new accelerated‐/blast‐phase transformations occurred with bosutinib; four occurred with imatinib. Early response (BCR‐ABL1/ABL1 ≤ 10%, 3 months) was associated with better CCyR and MMR rates by 12 and 24 months (both arms). Gastrointestinal events and liver function test elevations were more common, and neutropenia, musculoskeletal events and oedema were less common with bosutinib. Discontinuations due to adverse events were more common with bosutinib versus imatinib (most commonly alanine aminotransferase elevation: 4% vs. <1%); most occurred within the first 12 months. Cardiovascular adverse events were similar in both arms. Bosutinib continues to demonstrate good efficacy and manageable tolerability in newly diagnosed CP‐CML patients. |
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Keywords: | bosutinib tyrosine kinase inhibitor chronic myeloid leukaemia CML BCR‐ABL1 |
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