TY - JOUR
T1 - Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia
T2 - BRIGHT AML 1019 Phase III trials
AU - Cortes, Jorge E.
AU - Dombret, Hervé
AU - Merchant, Akil
AU - Tauchi, Tetsuzo
AU - Dirienzo, Christine G.
AU - Sleight, Barbara
AU - Zhang, Xiaoxi
AU - Leip, Eric P.
AU - Shaik, Naveed
AU - Bell, Timothy
AU - Chan, Geoffrey
AU - Sekeres, Mikkael A.
N1 - Funding Information:
This study is sponsored by Pfizer. JE Cortes receives research support for his institution from BMS, Astellas, Arog, Daiichi, Pfizer, Novartis, Immunogen, Merus, Jazz, Takeda, BergenBio, Tolero, Sun Pharma, Trovagen and Amphivena. He receives consulting honorarium from Astellas, BMS, Daiichi, Pfizer, Novartis, Jazz and Biopath Holdings. H Dombret has a consulting or advisory role for Amgen, Astellas Pharma, AbbVie, Celgene, Cellectis, Daiichi Sankyo, Incyte, Janssen, Jazz Pharmaceuticals, Karyopharm Therapeutics, Immunogen, Shire-Baxalta, Menarini, Novartis, Otsuka, Pfizer, SERVIER and Sunesis Pharmaceuticals. He receives research funding from Amgen, Incyte, Novartis, Jazz Pharmaceuticals, SERVIER and Pfizer.
Funding Information:
This study is sponsored by Pfizer. JE Cortes receives research support for his institution from BMS, Astellas, Arog, Daiichi, Pfizer, Novartis, Immunogen, Merus, Jazz, Takeda, BergenBio, Tolero, Sun Pharma, Trovagen and Amphivena. He receives consulting honorarium from Astellas, BMS, Daiichi, Pfizer, Novartis, Jazz and Biopath Holdings. H Dombret has a consulting or advisory role for Amgen, Astellas Pharma, AbbVie, Celgene, Cellectis, Daiichi Sankyo, Incyte, Janssen, Jazz Pharmaceuticals, Karyopharm Therapeutics, Immunogen, Shire-Baxalta, Menarini, Novartis, Otsuka, Pfizer, SERVIER and Sunesis Pharmaceuticals. He receives research funding from Amgen, Incyte, Novartis, Jazz Pharmaceuticals, SERVIER and Pfizer. AA Merchant acts as a consultant and on the advisory board for Agios and Pfizer, and receives research funding from Pfizer. T Tauchi is in the Speakers’ Bureau for Bristol-Myers Squibb, Novartis and Pfizer. He receives research funding from Novartis. CG DiRienzo, B Sleight, XX Zhang, EP Leip, N Shaik, T Bell and G Chan are employees of Pfizer and own stock in Pfizer. MA Sekeres has a consulting or advisory role for Celgene and Millennium. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by S Li of Engage Scientific Solutions and funded by Pfizer.
Publisher Copyright:
© 2019 Pfizer Inc.
PY - 2019
Y1 - 2019
N2 - 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. Trial registration number: ClinicalTrials.gov identifier: NCT0341617.
AB - 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. Trial registration number: ClinicalTrials.gov identifier: NCT0341617.
KW - Hedgehog signaling pathway
KW - acute myeloid leukemia
KW - glasdegib
KW - intensive chemotherapy
KW - myelodysplastic syndrome
KW - nonintensive chemotherapy
KW - smoothened inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85074380285&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85074380285&partnerID=8YFLogxK
U2 - 10.2217/fon-2019-0373
DO - 10.2217/fon-2019-0373
M3 - Article
C2 - 31516032
AN - SCOPUS:85074380285
SN - 1479-6694
VL - 15
SP - 3531
EP - 3545
JO - Future Oncology
JF - Future Oncology
IS - 31
ER -
