Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials

被引：39

作者：

Cortes, Jorge E. ^{[1
,7
]}

Dombret, Herve ^{[2
]}

Merchant, Akil ^{[3
]}

Tauchi, Tetsuzo ^{[4
]}

DiRienzo, Christine G. ^{[5
]}

Sleight, Barbara ^{[5
]}

Zhang, Xiaoxi ^{[5
]}

Leip, Eric P. ^{[5
]}

Shaik, Naveed ^{[5
]}

Bell, Timothy ^{[5
]}

Chan, Geoffrey ^{[5
]}

Sekeres, Mikkael A. ^{[6
]}

机构：

[1] Augusta Univ, Georgia Canc Ctr, Augusta, GA 30912 USA

[2] Hop St Louis, Inst Univ Hematol, AP HP, Inst Rech St Louis, Paris, France

[3] Univ Southern Calif, Keck Sch Med, Dept Med, Los Angeles, CA 90033 USA

[4] Shin Yurigaoka Gen Hosp, Dept Hematol, Kawasaki, Kanagawa, Japan

[5] Pfizer Inc, Pfizer Oncol, New York, NY 10017 USA

[6] Cleveland Clin, Leukemia Program, Cleveland, OH 44195 USA

[7] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, Houston, TX 77054 USA

来源：

FUTURE ONCOLOGY | 2019年 / 15卷 / 31期

关键词：

acute myeloid leukemia; glasdegib; Hedgehog signaling pathway; intensive chemotherapy; myelodysplastic syndrome; nonintensive chemotherapy; smoothened inhibitor; HEDGEHOG PATHWAY; OLDER PATIENTS; INHIBITOR; PF-04449913; AZACITIDINE; RECOMMENDATIONS; CLASSIFICATION; MALIGNANCIES; COMBINATION; SURVIVAL;

D O I：

10.2217/fon-2019-0373

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Glasdegib, an oral Hedgehog pathway inhibitor, has been associated with significantly improved survival when combined with low-dose cytarabine in patients with untreated acute myeloid leukemia (AML) who were unsuitable for intensive chemotherapy, when compared with low-dose cytarabine alone. BRIGHT AML 1019 (NCT03416179) comprises two independently powered Phase III, randomized (1:1), double-blind global trials evaluating oral glasdegib 100 mg once daily or placebo plus one of two standard chemotherapy regimens in adults with untreated AML. The intensive trial combines glasdegib/placebo with cytarabine and daunorubicin (7 + 3), while the nonintensive trial combines glasdegib/placebo with azacitidine. The primary end point of both studies is overall survival. Secondary end points include response, time to and duration of response, event-free survival, safety, patient-reported outcomes and pharmacokinetics.

引用

页码：3531 / 3545

页数：15

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