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

on behalf of the BYOND Study Investigators

doi:10.1038/s41375-020-0915-9

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

on behalf of the BYOND Study Investigators

Jena University Hospital
University of Milano-Bicocca
Washington University School of Medicine in St. Louis
Haukeland University Hospital
University Hospital Aachen
Johns Hopkins Oncology Center
Miguel Servet University Hospital
University Hospital Uppsala
Central Institute of Mental Health, Medical Faculty Mannheim, University Heidelberg
Pfizer Inc.
Pfizer SLU
University of Bologna
Sylvester Comprehensive Cancer Center
Developmental Therapeutics LLC
Sant'Eugenio Hospital
Indiana Blood and Marrow Transplantation
SOD Ematologia
Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS)
Institut Paoli Calmettes
University Hospital of Catania
Bergonié Institute
Hospital Universitario Ramón y Cajal
Institut Lorrain du Coeur et des Vaisseaux University Hospital Nancy – Brabois
Trondheim University Hospital
Centre Hospitalier Universitaire de Nice
University of Southern California
Charité – Universitätsmedizin Berlin
Pozuelo de Alarcon
Seattle Cancer Care Alliance
Hospital Universitari Vall d'Hebron
Ordensklinikum Linz Gmbh Barmherzige Schwestern
Niguarda ca' Granda Hospital
San Luigi Gonzaga SCDU
Institut Universitaire du Cancer Toulouse
New York-Presbyterian Hospital/Weill-Cornell Medical Center
Hopital Andre Mignot
Hospital Universitario de Salamanca
Hospital Universitario Y Politécnico La Fe
University Medical Center Hamburg-Eppendorf
University Hospital Cologne
Medical University Innsbruck
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Hospital de la Princesa
Hematologiskt Centrum

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

74 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	2125-2137
Number of pages	13
Journal	Leukemia
Volume	34
Issue number	8
DOIs	https://doi.org/10.1038/s41375-020-0915-9
Publication status	Published - 1 Aug 2020
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1038/s41375-020-0915-9

Cite this

@article{c07fe8fc11ef4e869d4f7a60c0202fa5,

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

abstract = "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.",

author = "\{on behalf of the BYOND Study Investigators\} and Andreas Hochhaus and Carlo Gambacorti-Passerini and Camille Abboud and Gjertsen, \{Bj{\o}rn Tore\} and Br{\"u}mmendorf, \{Tim H.\} and Smith, \{B. Douglas\} and Thomas Ernst and Pilar Giraldo-Castellano and Ulla Olsson-Str{\"o}mberg and Susanne Saussele and Nathalie Bardy-Bouxin and Andrea Viqueira and Eric Leip and Russell-Smith, \{T. Alexander\} and Jocelyn Leone and Gianantonio Rosti and Justin Watts and Giles, \{Francis J.\} and E. Abruzzese and Akard, \{L. P.\} and A. Bosi and F. Cervantes and A. Charbonnier and \{Di Raimondo\}, F. and G. Etienne and \{Garcia Gutierrez\}, V. and Guerci-Bresler, \{A. P.\} and H. Hjorth-Hansen and Karsenti, \{J. M.\} and Kelly, \{K. R.\} and \{Le Coutre\}, P. and \{Martinez Chamorro\}, C. and Oehler, \{V. G.\} and \{Orti Pascual\}, G. and A. Petzer and E. Pungolino and G. Rege-Cambrin and F. Rigal-Huguet and Roboz, \{G. J.\} and P. Rousselot and Sanchez-Guijo, \{F. M.\} and \{Sanz Santillana\}, G. and P. Schafhausen and C. Scheid and S. Schmidt and G. Specchia and Steegmann, \{J. L.\} and L. Stenke",

note = "Publisher Copyright: {\textcopyright} 2020, The Author(s).",

year = "2020",

month = aug,

day = "1",

doi = "10.1038/s41375-020-0915-9",

language = "English",

volume = "34",

pages = "2125--2137",

journal = "Leukemia",

issn = "0887-6924",

publisher = "Springer Nature",

number = "8",

}

TY - JOUR

T1 - Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia

T2 - primary results of the phase 4 BYOND study

AU - on behalf of the BYOND Study Investigators

AU - Hochhaus, Andreas

AU - Gambacorti-Passerini, Carlo

AU - Abboud, Camille

AU - Gjertsen, Bjørn Tore

AU - Brümmendorf, Tim H.

AU - Smith, B. Douglas

AU - Ernst, Thomas

AU - Giraldo-Castellano, Pilar

AU - Olsson-Strömberg, Ulla

AU - Saussele, Susanne

AU - Bardy-Bouxin, Nathalie

AU - Viqueira, Andrea

AU - Leip, Eric

AU - Russell-Smith, T. Alexander

AU - Leone, Jocelyn

AU - Rosti, Gianantonio

AU - Watts, Justin

AU - Giles, Francis J.

AU - Abruzzese, E.

AU - Akard, L. P.

AU - Bosi, A.

AU - Cervantes, F.

AU - Charbonnier, A.

AU - Di Raimondo, F.

AU - Etienne, G.

AU - Garcia Gutierrez, V.

AU - Guerci-Bresler, A. P.

AU - Hjorth-Hansen, H.

AU - Karsenti, J. M.

AU - Kelly, K. R.

AU - Le Coutre, P.

AU - Martinez Chamorro, C.

AU - Oehler, V. G.

AU - Orti Pascual, G.

AU - Petzer, A.

AU - Pungolino, E.

AU - Rege-Cambrin, G.

AU - Rigal-Huguet, F.

AU - Roboz, G. J.

AU - Rousselot, P.

AU - Sanchez-Guijo, F. M.

AU - Sanz Santillana, G.

AU - Schafhausen, P.

AU - Scheid, C.

AU - Schmidt, S.

AU - Specchia, G.

AU - Steegmann, J. L.

AU - Stenke, L.

PY - 2020/8/1

Y1 - 2020/8/1

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85086777225

U2 - 10.1038/s41375-020-0915-9

DO - 10.1038/s41375-020-0915-9

M3 - Article

C2 - 32572189

AN - SCOPUS:85086777225

SN - 0887-6924

VL - 34

SP - 2125

EP - 2137

JO - Leukemia

JF - Leukemia

IS - 8

ER -

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

Abstract

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