Olutasidenib用于突变型异柠檬酸脱氢酶1(mIDH1)急性髓性白血病(AML)患者的治疗。

IF 2.2 4区 医学 Q3 HEMATOLOGY Leukemia & Lymphoma Pub Date : 2024-08-01 Epub Date: 2024-03-27 DOI:10.1080/10428194.2024.2333451
Jorge Cortes, Brian A Jonas, Gary Schiller, Alice Mims, Gail J Roboz, Andrew H Wei, Pau Montesinos, P Brent Ferrell, Karen Wl Yee, Pierre Fenaux, Anthony Schwarer, Justin M Watts
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引用次数: 0

摘要

奥卢他尼是一种强效、选择性、口服、突变型异柠檬酸脱氢酶1(mIDH1)抑制剂,已获美国食品药品管理局批准用于治疗复发/难治性(R/R)急性髓性白血病(AML)。在此,我们报告了奥路替尼在18例mIDH1急性髓性白血病患者中的疗效和安全性,这些患者有的复发(10例),有的难治(6例),有的完全缓解但血液学恢复不完全(CRi;2例),有的接受了venetoclax联合治疗。在16例复发/难治患者中,4例(25%)达到完全缓解(CR),1例(6.3%)达到CR伴部分血液学恢复(CRh),7例(43.8%)达到复合完全缓解(CRc)。达到 CRc 的中位时间为 1.9 个月(1-2.8 个月)。截至数据截止日(2021 年 6 月 18 日),CRc 的中位持续时间尚未达到(范围为 1.2-NR,持续时间为 30.4 个月)。两名在研究开始时有 CRi 的患者都达到了 CR。安全性与奥卢他尼的总体情况一致。Olutasidenib 为既往接受过 venetoclax 治疗的 mIDH1 AML 患者提供了一种有价值的治疗选择。
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Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML).

Olutasidenib, a potent, selective, oral, mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor, is FDA-approved for relapsed/refractory (R/R) acute myeloid leukemia (AML). Here we report efficacy and safety of olutasidenib in 18 patients with mIDH1 AML who were relapsed (10), refractory (6) or had complete remission with incomplete hematologic recovery (CRi; 2) to a venetoclax combination. Of the 16 patients who were R/R, 4 (25%) achieved complete remission (CR), one (6.3%) achieved CR with partial hematologic recovery (CRh), and 7 (43.8%) achieved a composite complete remission (CRc). Median time to CRc was 1.9 months (range 1-2.8). As of data cutoff (18 June 2021), median duration of CRc was not reached (range, 1.2-NR, ongoing at 30.4+ months). Both patients with CRi at study entry achieved a CR. Safety was consistent with the overall profile of olutasidenib. Olutasidenib offers a valuable treatment option for patients with mIDH1 AML previously treated with venetoclax.

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来源期刊
Leukemia & Lymphoma
Leukemia & Lymphoma 医学-血液学
CiteScore
4.10
自引率
3.80%
发文量
384
审稿时长
1.8 months
期刊介绍: Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor
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