Trial reportBlood2023
Enasidenib vs conventional care in older patients with late-stage mutant-IDH2 relapsed/refractory AML: a randomized phase 3 trial.
Trial report in Blood, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02577406 (A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221), which is not on this map. Cited by 70 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
Who cites it
70 citing papers in PubMed, 2 syntheses or guidelines pooled it, 105 citations in OpenAlex.
- Next-generation sequencing for guiding matched targeted therapies in people with relapsed or metastatic cancer.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy and safety of IDH inhibitors in IDH-mutated cancers: a systematic review and meta-analysis of 4 randomized controlled trials.World journal of surgical oncology · 2024Pooled it
- Trial
- Cost-effectiveness of Enasidenib versus conventional care for older patients withLeukemia & lymphoma · 2025Trial
- Guadecitabine vs TC in relapsed/refractory AML after intensive chemotherapy: a randomized phase 3 ASTRAL-2 trial.Blood advances · 2024Trial
- Dynamic genetic and nongenetic RAS-pathway activation drives resistance to FLT3 and BCL2 inhibitor therapy.Blood · 2026Article
- Increasing TET Expression and 5-Hydroxymethylcytosine Formation by a Carbocyclic 5-Aza-2'-deoxy-cytidine Antimetabolite.Angewandte Chemie (International ed. in English) · 2026Article
- Real-World Outcomes of Acute Myeloid Leukemia Patients Undergoing Treatment With Tyrosine Kinase Inhibitor (TKI) Therapy Targeting FLT3, IDH1, or IDH2.Cancer reports (Hoboken, N.J.) · 2026Article
- DNMT3A/TET2-mediated epigenetic alteration in Type-1 diabetes dysregulates the haematopoiesis.Molecular biology reports · 2026Review
- The new era of AML therapy: current standards and emerging targets.International journal of clinical oncology · 2026Review
- Maintenance Therapy in Acute Myeloid Leukemia: Current Perspectives and Future Directions.Current oncology (Toronto, Ont.) · 2026Review
- Novel treatment strategies in acute myeloid leukemia.Blood research · 2026Review
- Article
- Identification and Management of Differentiation Syndrome in Emergency Settings: A Narrative Review.Cancers · 2026Review
- Review
- Article
- Improvements in Real-World Survival in the Setting of a Recent Paradigm Shift in Acute Myeloid Leukemia Treatment.European journal of haematology · 2026Article
- Targeted Therapy in Acute Myeloid Leukemia: Current Approaches and Novel Directions.Journal of personalized medicine · 2026Review
- Cancer Metabolism and Its Historical & Molecular Foundations: An Overview.Drugs and drug candidates · 2026Article
- Overcoming therapeutic challenges in acute myeloid leukemia: active targeting strategies by nano-drug delivery systems.Journal of translational medicine · 2026Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
27 authors at 20 institutions in 11 countries.
Funding
Abstract
This open-label, randomized, phase 3 trial (NCT02577406) compared enasidenib, an oral IDH2 (isocitrate dehydrogenase 2) inhibitor, with conventional care regimens (CCRs) in patients aged ≥60 years with late-stage, mutant-IDH2 acute myeloid leukemia (AML) relapsed/refractory (R/R) to 2 or 3 prior AML-directed therapies. Patients were first preselected to a CCR (azacitidine, intermediate-dose cytarabine, low-dose cytarabine, or supportive care) and then randomized (1:1) to enasidenib 100 mg per day or CCR. The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), time to treatment failure (TTF), overall response rate (ORR), hematologic improvement (HI), and transfusion independence (TI). Overall, 319 patients were randomized to enasidenib (n = 158) or CCR (n = 161). The median age was 71 years, median (range) enasidenib exposure was 142 days (3 to 1270), and CCR was 36 days (1 to 1166). One enasidenib (0.6%) and 20 CCR (12%) patients received no randomized treatment, and 30% and 43%, respectively, received subsequent AML-directed therapies during follow-up. The median OS with enasidenib vs CCR was 6.5 vs 6.2 months (HR [hazard ratio], 0.86; P = .23); 1-year survival was 37.5% vs 26.1%. Enasidenib meaningfully improved EFS (median, 4.9 vs 2.6 months with CCR; HR, 0.68; P = .008), TTF (median, 4.9 vs 1.9 months; HR, 0.53; P < .001), ORR (40.5% vs 9.9%; P <.001), HI (42.4% vs 11.2%), and red blood cell (RBC)-TI (31.7% vs 9.3%). Enasidenib safety was consistent with prior reports. The primary study endpoint was not met, but OS was confounded by early dropout and subsequent AML-directed therapies. Enasidenib provided meaningful benefits in EFS, TTF, ORR, HI, and RBC-TI in this heavily pretreated older mutant-IDH2 R/R AML population.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.