Glasdegib plus intensive or non-intensive chemotherapy for
untreated acute myeloid leukemia: results from the randomized,
phase 3 BRIGHT AML 1019 trial

J 2023

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR et. al.

Basic information

Original name

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial

Authors

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER (203 Czech Republic, belonging to the institution), Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN and Jorge E CORTES

Edition

Leukemia, London, Nature Publishing Group, 2023, 0887-6924

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 11.400 in 2022

RIV identification code

RIV/00216224:14110/23:00132494

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1038/s41375-023-02001-z

UT WoS

001052018400001

Keywords in English

polycythemia vera; ropeginterferon alfa-2b

Abstract

V originále

This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.

Citovat

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER, Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN and Jorge E CORTES. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. London: Nature Publishing Group, 2023, vol. 37, No 10, p. 2017-2026. ISSN 0887-6924. Available from: https://dx.doi.org/10.1038/s41375-023-02001-z.

@article{2348884,
   author = {Sekeres, Mikkael A and Montesinos, Pau and Novak, Jan and Wang, Jianxiang and Jeyakumar, Deepa and Tomlinson, Benjamin and Mayer, Jiří and Jou, Erin and Robak, Tadeusz and Taussig, David C and Dombret, Herve and Merchant, Akil and Shaik, Naveed and Brien, Thomas and Roh, Whijae and Liu, Xueli and Ma, Wendy and DiRienzo, Christine G and Chan, Geoffrey and Cortes, Jorge E},
   article_location = {London},
   article_number = {10},
   doi = {http://dx.doi.org/10.1038/s41375-023-02001-z},
   keywords = {polycythemia vera; ropeginterferon alfa-2b},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial},
   url = {https://www.nature.com/articles/s41375-023-02008-6},
   volume = {37},
   year = {2023}
}

TY  - JOUR
ID  - 2348884
AU  - Sekeres, Mikkael A - Montesinos, Pau - Novak, Jan - Wang, Jianxiang - Jeyakumar, Deepa - Tomlinson, Benjamin - Mayer, Jiří - Jou, Erin - Robak, Tadeusz - Taussig, David C - Dombret, Herve - Merchant, Akil - Shaik, Naveed - Brien, Thomas - Roh, Whijae - Liu, Xueli - Ma, Wendy - DiRienzo, Christine G - Chan, Geoffrey - Cortes, Jorge E
PY  - 2023
TI  - Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial
JF  - Leukemia
VL  - 37
IS  - 10
SP  - 2017-2026
EP  - 2017-2026
PB  - Nature Publishing Group
SN  - 08876924
KW  - polycythemia vera
KW  - ropeginterferon alfa-2b
UR  - https://www.nature.com/articles/s41375-023-02008-6
N2  - This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.
ER  -

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER, Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN and Jorge E CORTES. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. \textit{Leukemia}. London: Nature Publishing Group, 2023, vol.~37, No~10, p.~2017-2026. ISSN~0887-6924. Available from: https://dx.doi.org/10.1038/s41375-023-02001-z.

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