A phase 1/2 study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia

被引：0

作者：

Sawa, Masashi ^{[1
]}

Miyamoto, Toshihiro ^{[2
]}

Kim, Hee-Je ^{[3
]}

Hiramatsu, Yasushi ^{[4
]}

Cheong, June-Won ^{[5
]}

Ikezoe, Takayuki ^{[6
]}

Naoe, Tomoki ^{[7
]}

Akashi, Koichi ^{[8
]}

Morita, Satoshi ^{[9
]}

Kosako, Masanori ^{[10
]}

Ikegaya, Moyu ^{[10
]}

Terada, Wataru ^{[10
]}

Kadokura, Takeshi ^{[10
]}

Hill, Jason ^{[11
]}

Miyawaki, Shuichi ^{[12
]}

Gill, Stanley C. ^{[11
]}

Heinloth, Alexandra ^{[11
]}

Hasabou, Nahla ^{[11
]}

机构：

[1] Dept Hematol & Oncol, Aichi, Japan

[2] Kanazawa Univ, Dept Hematol, Kanazawa, Ishikawa, Japan

[3] Catholic Univ Korea, Catholic Hematol Hosp, Seoul St Marys Hosp, Dept Hematol,Coll Med, Seoul, South Korea

[4] Japanese Red Cross Soc, Himeji Hosp, Dept Hematol & Oncol, Himeji, Hyogo, Japan

[5] Yonsei Univ Hlth Syst, Severance Hosp, Dept Internal Med, Seoul, South Korea

[6] Fukushima Med Univ Hosp, Dept Pediat Oncol, Fukushima, Japan

[7] Natl Hosp Org Nagoya Med Ctr, Nagoya, Aichi, Japan

[8] Kyushu Univ Hosp, Dept Med & Biosyst Sci, Fukuoka, Japan

[9] Kyoto Univ, Grad Sch Med, Kyoto, Japan

[10] Astellas Pharma Inc, Tokyo, Japan

[11] Astellas Pharm US Inc, Northbrook, IL USA

[12] Tokyo Metropolitan Otsuka Hosp, Div Hematol, Tokyo, Japan

来源：

INTERNATIONAL JOURNAL OF HEMATOLOGY | 2025年 / 121卷 / 01期

关键词：

Acute myeloid leukemia; Chemotherapy; Gilteritinib; Newly diagnosed; FLT3; mutation; MYELOID-LEUKEMIA;

D O I：

10.1007/s12185-024-03840-x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

ObjectiveThis interim analysis of a phase 1/2, open-label, single-arm study assessed the safety, efficacy, and pharmacokinetics of gilteritinib plus chemotherapy in adults with newly diagnosed FLT3 mutation-positive acute myeloid leukemia.MethodsIn sequential phase 1 and 2 studies, induction and consolidation therapy with gilteritinib 120 mg/day plus chemotherapy (induction: idarubicin/cytarabine once daily; consolidation: cytarabine twice daily) was followed by maintenance gilteritinib 120 mg/day monotherapy. Endpoints included maximum tolerated dose (MTD), recommended expansion dose (RED), and dose-limiting toxicity (phase 1), and complete remission (CR) rate following induction therapy (primary endpoint), overall survival (OS), safety, and pharmacokinetics (phase 2).ResultsIn phase 1, MTD was not reached and RED was 120 mg/day. In phase 2, the CR rate was 50.0% after induction (90% confidence interval [CI] 40.4, 59.6); however, the lower confidence limit did not exceed the pre-defined 55% benchmark. Composite CR (CRc) rates were high following induction (86.6%, 95% CI [77.3, 93.1]), consolidation, and maintenance therapy (87.8%, 95% CI [78.7, 94.0], each). The probability of OS was 86.6% at 12 months. No new safety findings were reported.ConclusionIn this interim analysis, gilteritinib 120 mg/day in combination with chemotherapy was well tolerated, with similar CRc rates to previous studies.

引用

页码：56 / 67

页数：12

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