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Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial.

Author: BennettJohn M, DiNardoCourtney D, DöhnerHartmut, FathiAmir T, FrattiniMark G, GongJing, HasanMaroof, KantarjianHagop M, LerschFrederik, Martin-RegueiraPatricia, MontesinosPau, SchuhAndre C, SteinEytan M, VyasParesh, WeiAndrew H, ZeidanAmer M, de BottonStéphane

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This phase 1b/2 trial evaluated the safety and activity of enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukemia. The combination therapy was well tolerated and significantly improved overall response rates compared to azacitidine monotherapy.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Enasidenib is an oral inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) proteins. We evaluated the safety and activity of enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia ineligible for intensive chemotherapy. ...See full text at original site
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引用元：
https://doi.org/10.1016/S1470-2045(21)00494-0

データ提供：米国国立医学図書館（NLM）

Enasidenib Plus Azacitidine: A Promising Combination for Mutant-IDH2 Acute Myeloid Leukemia

This study delves into the complex world of [acute myeloid leukemia (AML)] and investigates the efficacy of enasidenib, an oral inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) proteins, in combination with azacitidine for treating newly diagnosed, mutant-IDH2 AML ineligible for intensive chemotherapy. The authors conducted a phase 1b/2 trial, evaluating the safety and activity of enasidenib plus azacitidine compared to azacitidine alone. The study demonstrated that the combination regimen was well-tolerated and significantly improved overall response rates compared to azacitidine monotherapy. These promising findings suggest that enasidenib plus azacitidine may represent a significant advancement in the treatment of mutant-IDH2 AML.

Enasidenib Plus Azacitidine: A Potential Breakthrough in Treating Mutant-IDH2 AML

The study's findings offer exciting potential for patients with mutant-IDH2 AML, particularly those ineligible for intensive chemotherapy. The combination of enasidenib and azacitidine showed a significant improvement in overall response rates compared to azacitidine alone. This suggests that this regimen could potentially improve outcomes and quality of life for patients with this challenging type of AML.

Navigating AML Treatment: Exploring New Options for Improved Outcomes

AML is a serious and often aggressive disease. This study underscores the importance of ongoing research to develop new and more effective treatment options. The combination of enasidenib and azacitidine shows promise for improving outcomes for patients with mutant-IDH2 AML, offering a potential new path for better treatment and potentially extending life expectancy. As always, consultation with a healthcare professional is crucial to determine the best treatment course for each individual.

Dr.Camel's Conclusion

This study, like a desert explorer discovering a hidden spring, offers a glimmer of hope for patients with mutant-IDH2 AML. The combination of enasidenib and azacitidine has shown promise for improving treatment outcomes, potentially leading to a brighter future for those affected by this challenging disease. This research is a testament to the ongoing quest for innovative therapies to improve patient care and outcomes in the battle against cancer.

Date :
  1. Date Completed 2021-11-17
  2. Date Revised 2022-08-12
Further Info :

Pubmed ID

34672961

DOI: Digital Object Identifier

10.1016/S1470-2045(21)00494-0

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・Side Effects of enasidenib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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