| 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. |
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@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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