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

GND
1107039339
ORCID
1107039339
Zugehörigkeit
Klinik für Innere Medizin II, Universitätsklinikum Jena
Hochhaus, Andreas;
Zugehörigkeit
University of Milano-Bicocca, Monza, Italy
Gambacorti-Passerini, Carlo;
Zugehörigkeit
Washington University School of Medicine, St. Louis, USA
Abboud, Camille;
Zugehörigkeit
Haukeland University Hospital, Helse Bergen, and University of Bergen, Bergen, Norway
Gjertsen, Bjørn Tore;
Zugehörigkeit
Universitätsklinikum RWTH Aachen, Aachen, Germany
Brümmendorf, Tim H.;
Zugehörigkeit
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, USA
Smith, B. Douglas;
GND
129357685
Zugehörigkeit
Klinik für Innere Medizin II, Universitätsklinikum Jena
Ernst, Thomas;
Zugehörigkeit
CIBER Enfermedades Raras, Miguel Servet University Hospital, Zaragoza, Spain
Giraldo-Castellano, Pilar;
Zugehörigkeit
University of Uppsala and Department of Hematology, University Hospital, Uppsala, Sweden
Olsson-Strömberg, Ulla;
Zugehörigkeit
Universitätsmedizin Mannheim, Heidelberg University, Mannheim, Germany
Saussele, Susanne;
Zugehörigkeit
Pfizer International Operation-Oncology, Paris, France
Bardy-Bouxin, Nathalie;
Zugehörigkeit
Pfizer SLU, Madrid, Spain
Viqueira, Andrea;
Zugehörigkeit
Pfizer Inc, Cambridge, USA
Leip, Eric;
Zugehörigkeit
Pfizer Inc, New York, USA
Russell-Smith, T. Alexander;
Zugehörigkeit
Pfizer Inc, Cambridge, USA
Leone, Jocelyn;
Zugehörigkeit
University Hospital, University of Bologna, Bologna, Italy
Rosti, Gianantonio;
Zugehörigkeit
University of Miami, Sylvester Comprehensive Cancer Center, Miami, USA
Watts, Justin;
Zugehörigkeit
Developmental Therapeutics Consortium, Chicago, USA
Giles, Francis J.

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.

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