Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia:: primary results of the phase 4 BYOND study Hochhaus, Andreas Gambacorti-Passerini, Carlo Abboud, Camille Gjertsen, Bjørn Tore Brümmendorf, Tim H. Smith, B. Douglas Ernst, Thomas Giraldo-Castellano, Pilar Olsson-Strömberg, Ulla Saussele, Susanne Bardy-Bouxin, Nathalie Viqueira, Andrea Leip, Eric Russell-Smith, T. Alexander Leone, Jocelyn Rosti, Gianantonio Watts, Justin Giles, Francis J. article article article Text https://doi.org/10.1038/s41375-020-0915-9 https://nbn-resolving.org/urn:nbn:de:gbv:27-dbt-20230515-204254-006 https://www.db-thueringen.de/receive/dbt_mods_00057314 https://www.db-thueringen.de/receive/dbt_mods_00057314 doc-type:Article ScholarlyArticle ddc:610 Chronic myeloid leukaemia Drug development 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 last 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. 2020-08 13 Seiten eng Leukemia -- 0887-6924 -- 1476-5551 https://creativecommons.org/licenses/by/4.0/ public info:eu-repo/semantics/openAccess