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Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study

Andreas Hochhaus, on behalf of the BYOND Study Investigators, Carlo Gambacorti-Passerini, Camille Abboud, Bjørn Tore Gjertsen, Tim H. Brümmendorf, B. Douglas Smith, Thomas Ernst, Pilar Giraldo-Castellano, Ulla Olsson-Strömberg, Susanne Saussele, Nathalie Bardy-Bouxin (+7 others)
2020 Leukemia  

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Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after
more » ... ast enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.
doi:10.1038/s41375-020-0915-9 pmid:32572189 pmcid:PMC7387243 fatcat:rmqxlvgfhjfjdedazzs4x4h43u
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Andreas Hochhaus, on behalf of the BYOND Study Investigators, Carlo Gambacorti-Passerini, Camille Abboud, Bjørn Tore Gjertsen, Tim H. Brümmendorf, B. Douglas Smith, Thomas Ernst, Pilar Giraldo-Castellano, Ulla Olsson-Strömberg, Susanne Saussele, Nathalie Bardy-Bouxin, Andrea Viqueira, Eric Leip, T. Alexander Russell-Smith, Jocelyn Leone, Gianantonio Rosti, Justin Watts, Francis J. Giles. "Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study." Leukemia 34.8 (2020) 2125-2137