Ｄｅｌｔａ－Ｆｌｙ Ｐｈａｒｍａ(株)【4598】の掲示板 2024/04/27〜2024/05/07
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965
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GilteritinibのP3試験（r/r FLT3-Mutated AML）
（NCT02421939、N Engl J Med. 2019;381:1728-1740.）
計371症例（Primary end point：OS、CR with full or partial hematologic recovery）
Gilteritinib (n = 247) vs. Salvage chemotherapy (n = 124)
Median OS: 9.3 (95% CI 7.7-10.7) vs. 5.6 (95% CI 4.7-7.3)
(Hazard ratio for death=0.64、95% CI 0.49-0.83, P<0.001)
CR with fHazard ratio for death, 0.64 (95% CI, 0.49-0.83, P<0.001)
ull or partial hematologic recovery: 34.0% vs. 15.3%
(risk difference, 18.6 percentage points; 95% CI, 9.8 to 27.4)
CR: 21.1% vs. 10.5%
(risk difference, 10.6 percentage points; 95% CI, 2.8 to 18.4)
QuizartinibのP3試験（r/r FLT3-ITD AML）
(NCT02039726、Lancet Oncol. 2019;20:984-997.)
計367症例（Primary end point：OS）
Gilteritinib (n = 245) vs. Salvage chemotherapy (n = 122)
Median OS: 6.2 (95% CI 5.3-7.2) vs. 4.7 (95% CI 4.0-5.5)
(OS, hazard ratio 0.76 [95% CI 0.58-0.98; p=0.02]).
Median Age: 55.0 vs. 57.5
far*****
UproleselanのP3試験（r/r AML）(進行中)
NCT03616470（388症例）
NCT05054543（140症例）(Chinese patients)
ElacytarabineのP3試験（r/r AML）
（NCT01147939、Clin Oncol. 2014;32:1919-26.）
計381症例（Primary end point：OS）
Elacytarabine (n = 191) vs. Investigator choice control (n = 190)
OS: 3.5 months (95% CI 2.8 to 4.8) vs. 3.3 months (95% CI 2.9 to 4.4)
CR: 23% vs. 21%
CRi: 15% vs. 12%
Mean Age: 59 vs. 60
No. of previous regimens‖
1: 9% vs. 9%
2: 61% vs. 67%
>=3: 30% vs. 24%
VosaroxinのP3試験（first r/r AML）
（NCT01191801、Lancet Oncol. 2015;16:1025-1036.）
計711症例（Primary end point：OS）
Vosaroxin plus cytarabine (n = 356) vs. cytarabine (n = 355)
Median OS: 7.5 (95% CI 6.4-8.5) vs. 6.1 (95% CI 5.2-7.1)
(Hazard ratio 0.87, 95% CI 0.73-1.02,
Unstratified log-rank p=0.061; stratified p=0.024)
CR: 30% vs. 16%, p<0.0001
CR/CRp/CRi: 37% vs. 19%
mAge: 64 vs. 63
No. of previous induction cycles
1: 274 vs. 259
2: 82 vs. 95
>2: 0 vs.