Idhifa (enasidenib) / BMS, Royalty, Servier, Schrodinger - LARVOL DELTA

Real-world outcomes of myelodysplastic syndrome and chronic myelomonocytic leukemia treated with IDH1 and IDH2 inhibitors in the frontline setting (ASH 2025) - "Selective IDH1/2 inhibitors including ivosidenib (IDH1), olutasidenib (IDH1), and enasidenib (IDH2) are currently approved for IDH1/2-mutated (mIDH1/2) relapsed/refractory (r/r) acute myeloid leukemia; ivosidenib is also approved for mIDH1 r/r MDS based on clinical benefit observed in 18 patients on trial AG120-C-001...Patients previously treated with venetoclax (VEN) or a hypomethylating agent (HMA) were excluded... This study highlights safety and efficacy of IDH inhibitors, particularly among older adults with treatment-naïve MDS or CMML. Nearly half of our cohort were adults >80 years, a group often underrepresented in pivotal clinical trials. The overall response rate (CR + CRl + CRh) was 88.9% among 9 patients with BME; 50% of the entire cohort achieved PB-CR and median OS was 26 months."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • IDH1 • IDH2

Utilization patterns of venetoclax-based regimens for AML in a community based setting & representative populational analyses (ASH 2025) - "In first line setting, 22 patients (52.3%) received Venetoclax with azacitidine, 17 patients 40.1% received decitabine, 2 patients (4.8%) with cladribine and cytarabine, and 2 patients (4.8%) received Venetoclax alone...6 patients (40%) received azacitidine with venetcloax, 6 patients (40%) received decitabine, 1 patient (6.7%) received cytarabine, 1 patient (6.7%) received enasidenib, and one patient (6.7%) received nelarabine, cyclophosphamide, and cytarabine... The median age at diagnosis was 64 years (range 21-86). 47% patients were female gender. 24.5% of patients were Black or African-American, 71.4% were White, 1% were Asian, and 3.1% were more than one race."

Clinical • Acute Myelogenous Leukemia • Febrile Neutropenia • Hepatology • Liver Failure • Neutropenia • Renal Disease • CEBPA • DDX41 • NPM1 • TP53

Efficacy and safety of salvage therapies in relapsed/refractory Acute Myeloid Leukemia: A systematic review and network meta-analysis (ASH 2025) - "For safety, Cytarabine showed the lowest incidence of AEs (SUCRA = 0.71), while Enasidenib demonstrated the best profile in reducing mortality (SUCRA = 0.87). This NMA highlights Gilteritinib as the most effective and safest salvage therapy for R/R AML, particularly in patients with FLT3-mutated disease. Gemtuzumab Ozogamicin, Apamistamab, and Enasidenib also showed favorable outcomes, depending on molecular profiles and clinical priorities. These findings underscore the importance of individualized therapy selection based on efficacy, safety, and molecular characteristics."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • FLT3

Rhabdomyolysis in patients taking isocitrate dehydrogenase inhibitors for R/R Acute Myeloid Leukemia (ASH 2025) - "She was started on treatment with azacitidine, venetoclax, and magrolimab and achieved MRD-negative CR after cycle 1, then went on to complete 6 cycles of therapy, followed by 4 cycles of maintenance therapy with combination decitabine/cedazuridine and venetoclax prior to relapse. She was then treated with combination decitabine/cedazuridine, venetoclax, and ivosidenib...Azacitidine was discontinued after C33, at which time she continued on enasidenib monotherapy...She was on a stable dose of atorvastatin at the time of this event and had recently started azithromycin for symptoms of upper respiratory tract infection...al 2015). We hypothesize that rhabdomyolysis observed with IDH inhibitors may reflect a convergence of metabolic stressors, particularly in susceptible populations such as elderly patients with low muscle mass, and those on concomitant statins."

Clinical • Acute Myelogenous Leukemia • Brain Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • Glioma • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Leukemia • Musculoskeletal Pain • Myelodysplastic Syndrome • Respiratory Diseases • Solid Tumor • Thrombocytopenia • IDH1 • IDH2

Azacitidine-associated cardiotoxicity: A systematic review of case reports, observational studies, and clinical trials (ASH 2025) - "Concomitant therapies were reported in 5 studies, including case reports and observational studies: venetoclax (n=7), enasidenib (n=1), pembrolizumab (n=1) and cytarabine (n=1), with 4 patients receiving azacitidine monotherapy. Azacitidine-associated cardiotoxicity is a rare but potentially serious complication, most often manifesting as pericarditis or pericardial effusion, with some cases progressing to tamponade. Events typically occurred early in treatment—frequently during the first two cycles—and within the first two weeks of therapy. All reported cases involved patients with AML or MDS, and nearly half were receiving combination therapy, particularly with venetoclax."

Case report • Clinical • Observational data • Review • Acute Myelogenous Leukemia • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Dyslipidemia • Heart Failure • Hematological Malignancies • Hypertension • Infectious Disease • Leukemia • Metabolic Disorders • Myelodysplastic Syndrome • Renal Disease • Respiratory Diseases • Type 2 Diabetes Mellitus

Maintenance with hypomethylating agent + venetoclax after intensive induction chemotherapy in patients with newly diagnosed Acute Myeloid Leukemia (ASH 2025) - "Background Consolidative therapy with high/intermediate-dose cytarabine is standard practice for fit patients with newly diagnosed acute myeloid leukemia (ND-AML) who achieve complete remission (CR) after receiving intensive induction chemotherapy (IC). Oral azacitidine is approved as maintenance therapy in patients who achieve CR after IC but are unable to complete intensive consolidation therapy...Five patients (20%) received a FLT3 inhibitor with HMA and VEN (3 quizartinib, 2 gilteritinib), and 1 patient (4%) received an IDH-2 inhibitor (enasidenib)...These findings must be interpreted in the context of several limitations: a relatively small sample size, a median of one maintenance cycle, and the absence of scheduled repeat disease assessments. Larger, prospective studies are needed to confirm these observations and better define the role of HMA + VEN in this setting."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • FLT3 • IDH1 • IDH2 • TP53

Efficacy of novel agents in the treatment of acute myeloid leukemia and myelodysplastic syndrome: A systematic review and meta-analysis (ASH 2025) - "Newer agents included for AML were Guadectiabine, Magrolimab, Alvocidib, Enasidenib, Flotetuzumab, Vadastuximab, Mitoxantrone, Pevonedistat, Entospletinib, Eprenetapopt, Belinostat, Onvansertib, Panobinostat, Cediranib Maleate, Nilotinib, Emavusertib, and anti-CD45 antibody (DOTA-BC8). The newer agents investigated for MDS included Rigosertib, Imetelstat, Pembrolizumab, Enasidenib, Sabatolimab, Ivosidenib, Elitercept, Pevonedistat, Emavusertib, Atezolizumab, and Olutasidenib...All patients were treated concomitantly with either azacitidine (77%) or decitabine (23%)... This meta-analysis and systematic review demonstrate promising efficacy for novel agents in AML and MDS patients. There is a need for prospective trials with larger patient populations to investigate these agents further."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • TP53

An investigation of somatic mutations in IDH genes in peripheral blood in the all of us research program (ASH 2025) - "In a general hospital setting, IDH somatic mutation rate was low. Myeloid malignancy or cytopenia were present in majority of the individuals with detected IDH mutations (VAF > 10%). Since IDH mutations can be targeted by ivosidenib or enasidenib, adequate hematological evaluation of individuals with incidental finding of these mutations and enrollment to clinical trials should be considered in the future guidelines."

Acute Myelogenous Leukemia • Autoimmune Hepatitis • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Hepatology • Immunology • Inflammatory Arthritis • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Rheumatoid Arthritis • Rheumatology • IDH1 • IDH2

A multiarm phase 1b study of personalized oral maintenance therapy with decitabine/cedazuridine (ASTX727) plus physician's choice of venetoclax, gilteritinib, enasidenib, or ivosidenib in Acute Myeloid Leukemia (ASH 2025) - P1 | "Pts were required to have received at least 2 courses of intensive chemotherapy(intermediate to high-dose cytarabine-based) or 3 courses of low-intensity therapy (HMA or low-dosecytarabine-based) prior to enrollment. Personalized fully oral maintenance therapy is feasible in AML. Myelosuppression andinfections were the most common adverse events. Further enrollment and follow-up is needed toevaluate efficacy."

Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Leukemia • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • TP53

Healthcare resource utilization and cost of molecular targeted versus non-targeted therapies in acute myeloid leukemia (ASH 2025) - "We examined AML-related HCRU and costs over a 12-month period following treatment initiation.Patients were categorized into two sub-cohorts: (1) those receiving MTT (ivosidenib, enasidenib,midostaurin, gilteritinib) and (2) biomarker-positive patients (IDH1, IDH2, FLT3) treated only with non-MTT. For AML patients with actionable molecular mutations, treatment with MTTs results inreduced healthcare utilization but increased total costs, primarily due to drug expenses. These findingsemphasize the economic trade-offs in precision oncology and highlight the necessity for strategies toenhance the cost-effectiveness of MTTs in routine care."

HEOR • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • FLT3 • IDH1 • IDH2

A randomized Phase II trial of ASTX727 and venetoclax with or without enasidenib for newly diagnosed older adults with IDH2 mutant Acute Myeloid Leukemia: A myelomatch substudy (MM1OA-S03) (ASH 2025) - P2 | "In IDH1 mutant AML, a phase 1btrial of the combination of the IDH1 inhibitor ivosidenib with venetoclax and azacitidine resulted in anoverall response rate of 94% with MRD negativity achieved in 77%, without any patients discontinuingtherapy due to intolerance. The study wasactivated on April 1, 2025 and is expected to continue until October 2027. Funding: Funding: NIH/NCI grants U10CA180888, U10CA180819"

Clinical • P2 data • Acute Myelogenous Leukemia • Multiple Myeloma • IDH1 • IDH2

Early real-world experience with revumenib outside of a clinical trial setting: A single center retrospective review of efficacy and tolerability (ASH 2025) - "13 (72%) pts receivedhypomethylating agents and venetoclax in combination with revumenib and 1 pt received revumenibwith enasidenib. Early real-world data for revumenib confirms good tolerability with no AEs leading todiscontinuations. Early efficacy data shows excellent activity across molecular and disease subsets.Longer term follow-up data, inclusive of outcomes in molecular subsets, will be presented at the meeting."

Real-world • Real-world evidence • Retrospective data • Review • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Infectious Disease • Leukemia • Septic Shock • DNMT3A • FLT3 • IDH1 • KMT2A • NPM1 • NUP98 • TET2 • WT1

Impact of social determinants of health on access to molecular targeted therapy in AML and MDS: A real-world analysis (ASH 2025) - "MTTwas defined as receiving ivosidenib (IDH1), enasidenib (IDH2), or midostaurin/gilteritinib (FLT3) for bothcohorts.We evaluated eleven SDOH domains: unemployment, financial strain, food insecurity, housing instability,interpersonal safety concerns, low educational attainment, mental health disorders, physical inactivity,poor access to care, substance use, and transportation barriers. The modest association betweenfinancial strain and therapy receipt in AML warrants further investigation but was not observed in MDS.These findings suggest that system-level barriers, such as institutional protocols, clinician practices, andpayer dynamics, may play a more substantial role in driving disparities in precision oncology. Futureresearch should prioritize identifying and addressing these structural impediments to promote broadand consistent access to molecular testing and targeted therapies for individuals with myeloidmalignancies."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • FLT3 • IDH1 • IDH2 • SF3B1

Underexplored mutations in plasma cell myeloma (ASH 2025) - "Many FDA-approved therapies exist in other cancers (such as sotorasib, selumetinib,vemurafenib, enasidenib, midostaurin, ruxolitinib, crizotinib, erlotinib), though these remain largelyunexplored in PCM. CHIP mutation burden in MM / PCM was 40%, Our analysis identified several potentially targetablemutations in pts with PCM, including KRAS, NRAS, BRAF, IDH2, FLT3, JAK2, ALK, and EGFR. Clonalhematopoiesis (CH/CHIP) mutations, such as DNMT3A, TET2, ASXL1, and SRSF2, were also observed.Although the lineage origin of several targetable mutations remains unclear, the likely high plasma cellburden in PCM cases suggests that many may originate within the malignant plasma cell clone. Thishypothesis warrants systematic investigation in future studies."

Tumor mutational burden • Hematological Malignancies • Multiple Myeloma • ALK • ASXL1 • BCOR • BRAF • CALR • CREBBP • CSF3R • DNMT3A • EGFR • FLT3 • GNAS • IDH2 • JAK2 • KRAS • NRAS • PHF6 • PPM1D • PRPF8 • SRSF2 • SUZ12 • TET2 • TMB • TP53

IDH mutant MDS: Proposal for disease subset recognition based on molecular and clinical features, and the availability of targeted therapies (ASH 2025) - "For example, del5q MDS accounts for <5% of MDS, but the impact of lenalidomide treatmentemphasizes the need to identify those patients (pts)...Reponses to azacitidine were higher among IDH1 & 2 MT pts compared to WT (ORR (CR+PR+HI) 49.1%,48.1%, and 37.5%, respectively, and CR was 14.3%, 14% and 10.4%, respectively) (p=0.024 compared toWT and p=1.0 between IDH1 & 2).Among IDH1 MT pts, 16 pts received ivosidenib at any timepoint including AML...Three ptsreceived olutasidenib after ivosidenib, no response was observed.Among IDH2 MT pts, 42 received enasidenib at any timepoint including AML...Treatment with IDH inhibitors during the disease coursesuggests survival benefit among those pts. Our findings suggest the recognition of IDH MT MDS as aunique disease subset."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Immunology • Myelodysplastic Syndrome • ASXL1 • IDH1 • IDH2 • RUNX1 • SF3B1 • SRSF2 • TET2 • TP53

Multicenter Phase II trial of enasidenib as maintenance treatment following allogeneic stem cell transplantation in IDH2-mutated myeloid neoplasms – the IDH2-post-allo-trial (NCT04522895) (ASH 2025) - P2 | "During study, 21 pts (45%) developed aGvHD (Io 13%, IIo 9%, IIIo 17%, IVo 6%) and 23pts (49%) developed cGvHD (mild 36%, moderate 45%, severe 18%).The estimated 2-year cumulative incidence of relapse after allo-SCT was 17% with 3 pts (6%) relapsingwhile on maintenance therapy and 4 pts (9%) in median 5 months (range 1 to 7 months) after cessationof Enasidenib. NRM at 2 years was 9%, while 2-year RFS and OS after allo-SCT were 73% and 84%.ConclusionsEnasidenib is safe and tolerable with preliminary activity as maintenance after allo-SCT, which meritsfurther validation by comparison with historical controls and ideally in prospective, randomized trials."

Clinical • P2 data • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Neutropenia • Thrombocytopenia • Transplantation • IDH2

Real-world experience with IDH inhibitors in Acute Myeloid Leukemia: A german multicenter analysis with a focus on differentiation syndrome (ASH 2025) - "AML patients who received either enasidenib or ivosidenib outside of aclinical trial were included...Azacitidine wasthe most frequent combination partner (n=35, 63%), while decitabine or low-dose AraC were usedinfrequently. One patient received ivosidenib, azacitidine and venetoclax as a triplet...Seven patients additionally received steroids; five received a combination of steroidsand hydroxyurea (HU), and one patient was treated with HU alone...DS occurred more frequently than previously reported.While most cases resolved, two were fatal. We observed a broad time range of DS onset, not limited tothe first treatment cycle or to one DS episode, highlighting the need for close patient monitoring."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Metabolic Disorders • Neutropenia • ASXL1 • DNMT3A • IDH1 • IDH2 • NPM1

Mutations in IDH1 and IDH2 portend a poor prognosis in adult patients with acute lymphoblastic leukemia (ASH 2025) - "One pt with IDH1mut T-ALL and 2 ptsIDH2mut T-ALL received ivosidenib and enasidenib, respectively, in salvage: the IDH1mut pt had noresponse and the 2 IDH2mut pts achieved CR with a median duration of response of 17 months (3-31)before relapsing.The median event-free survival (EFS) for IDHmut pts was 16 months, with a 3-year EFS rate of 28%, vs. amedian EFS of 69 months and a 3-year EFS rate of 60% in IDHwt pts (p=0.0005). Co-occurring mutations include DNMT3A, NOTCH1, and NRAS, which were enriched inpts with T-ALL. Novel therapeutic strategies, including venetoclax and IDH inhibitors, are warranted inthis high-risk subgroup."

Clinical • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • T Acute Lymphoblastic Leukemia • BCOR • DNMT3A • IDH1 • IDH2 • IKZF1 • JAK1 • KRAS • NOTCH1 • NRAS • SRSF2 • TET2 • TP53

Real-world practice patterns of IDH inhibitors and outcomes of on-label IDH inhibitor use for Acute Myeloid Leukemia in the United States (ASH 2025) - "In the U.S., ivosidenib (ivo) is approved with or without azacitidine (aza) in the frontline (FL) and asmonotherapy in relapsed/refractory (R/R) IDH1-mutated (mut) AML. Olutasidenib (oluta) is approved asmonotherapy for R/R IDH1-mut AML...Overall, 209 of387 patients (54%) received IDHi regimens on-label.In FL IDH1-mut AML (n=45), 11 received ivo monotherapy, 25 aza/ivo, and 9 used off-label combinations:3 hypomethylating agent (HMA) + venetoclax (ven) + ivo, 5 decitabine/ivo, 1 intensive chemotherapy(IC)/ivo...In R/R IDH2-mut AML(n=189), 119 patients received ena monotherapy and 70 received off-label combinations (25 HMA/ena, 30HMA/ven/ena, 7 IC/ena, 6 ena/gilteritinib, and 2 other).In on-label treatment of FL IDH1-mut AML, one of four patients with response assessment of FL ivomonotherapy had a CR/CRh...Practice patterns for IDH inhibitors in AML vary considerably, with high amounts of off-label use.Response rates for ivosidenib and enasidenib in the real-world setting..."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • IDH1 • IDH2

Financial Toxicity and Quality of Life in Patients Taking Oral Therapy for Hematologic Malignancies (ASH 2023) - "MethodsWe used database query to identify patients at a midwestern, tertiary care, academic medical center who were 18 years or older and were prescribed Enasidenib, Ivosidenib, Venetoclax, Gilteritinib, Midostaurin, Ibrutinib, Acalabrutinib, Imatinib, Nilotinib, Ponatinib, Bosutinib, Duvelisib, or Idelalisib within the past 3 months. Financial stress and hardship were associated with worse satisfaction with QoL and worse experience of SE. Further study should define change in these features over time and interventions to mitigate distress."

Clinical • HEOR • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • CNS Disorders • Depression • Hematological Malignancies • Mood Disorders • Oncology • Oral Cancer • Psychiatry

Acute myeloid leukemia drug resistance: targetable nodes and the clinical trajectory of small-molecule inhibitors. (PubMed, Front Pharmacol) - "Over the past decade, six targeted or pathway-directed small molecules-midostaurin, gilteritinib, quizartinib, ivosidenib, enasidenib, venetoclax and glasdegib-have changed frontline and relapsed/refractory (R/R) practice in genomically defined subgroups or in patients unfit for intensive chemotherapy. Here we integrate mechanistic insights with clinical evidence to: (i) map resistance biology onto targetable nodes (apoptosis control; signalling kinases; chromatin/lineage programmes; RNA splicing; DNA-damage response; nuclear export; niche adhesion and innate immune evasion); (ii) summarise the clinical trajectory and current limits of approved and emerging small molecules (including menin and LSD1 inhibitors); (iii) propose rules for rational doublets and triplets that are biologically orthogonal yet clinically tolerable; (iv) outline a regulatory timeline for key AML small molecules; and (v) prioritise where drug development should go next, including next-generation..."

Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Practice Patterns of Transplant Centers Regarding Maintenance Treatment Post Allogeneic Hematopoietic Cell Transplantation in Acute Myeloid Leukemia: A Survey on Behalf of the EBMT Acute Leukemia Working Party (ASH 2023) - "9%) use hypomethylating agents (HMA) (azacitidine N=51 (82. 3%), decitabine N=6 (9. 6%), HMA with venetoclax N=23 (37%), HMA with donor lymphocyte infusion (DLI) N=38 (61%), or a combination of modalities in 42 (67...The most common choice was sorafenib in 82/93 (88. 2%) centers, midostaurin in 28 (30%), and gilteritinib in 30 (32...2%) use enasidenib... In this survey, the majority of responding EBMT-affiliated transplant centers is implementing post-transplant AML maintenance treatment, predominantly HMA and FLT3 inhibitors. Further studies are needed to clarify the appropriate strategy and duration of maintenance therapy. The study will help the EBMT to incorporate post-transplant strategies as a routine registry capture parameter."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3

A Phase 1b Multi-Center Study of the FLT3 Inhibitor Gilteritinib in Combination with the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients with Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-Occurring FLT3/IDH1 or FLT3/IDH2 Mutations (ASH 2023) - P1 | "This study is partially supported by Astellas Pharma Global Development, Inc. The study population will include patients with AML with dual FLT3 and IDH1/IDH2 mutations R/R to initial intensive induction therapy, or for patients treated with low intensity therapy, the patient must be refractory to treatment with a single agent hypomethylating agent (HMA) or low dose cytarabine (LDAC) (at least two cycles) or an HMA/LDAC in combination with venetoclax (at least one cycle) or another standard of care therapy (e. g. gemtuzumab ozogamicin, glasdegib/LDAC). Patients with a history of autologous or allogeneic stem cell transplant for AML are permitted to participate in the study."

Clinical • Combination therapy • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IDH1 • IDH2

Representation of Older Adults in FDA and EMA Registrational Trials for Acute Myeloid Leukemia (AML) (ASH 2024) - "Four drugs were approved in 2017 : midostaurin (ND FLT3-ITD/-TKD+ AML), enasidenib (R/R IDH2-mutated AML), CPX-351 (ND secondary-AML), and gemtuzumab ozogamicin (ND or R/R CD33+ AML)...Venetoclax combinations with decitabine/azacitidine/LDAC (newly diagnosed AML ≥75 years or unfit for IC) were approved between 2018-2020...Five trials (ivosidinib in ND, ivosidinib with azacitidine, glasdegib+LDAC, and venetoclax combined with azacitidine or LDAC) had a median age of >75 years and these trials were designed as specific to patients ≥75 years or those ineligible for IC...Trials assessing FLT3 inhibitors had a lower median age than other therapies with median ages of 48 (midostaurin), 56 (quizartinib), and 62 (gilteritinib) years on these trials...In the future, reporting of trials should include and distinguish patients both older than 65 and older than 75 for subgroup analyses. Standardization of age subgroup reporting with subpopulation analysis will better enable..."

Clinical • Acute Myelogenous Leukemia • Geriatric Disorders • Hematological Malignancies • Leukemia • Oncology • CD33 • FLT3 • IDH1 • IDH2

The Cytogenetic and Molecular Testing Landscape in Patients with Newly Diagnosed Acute Myeloid Leukemia in Routine Clinical Practices in the United States (ASH 2023) - "Tx for patients (pts) with actionable IDH1, IDH2, or FLT3 mutations includes Venetoclax (Ven)-based regimens (i.e. Ven+hypomethylating agents [HMAs] and Ven+low-dose cytarabine), HMA monotherapy (i.e. Azacitidine [Aza] or decitabine), and targeted Tx (i.e. ivosidenib±Aza, enasidenib±Aza, sorafenib±HMAs, and gilteritinib+Aza). This study found that cytogenetic and molecular testing have been integrated into routine clinical care settings for pts with ND AML receiving 1L Tx. The consistent testing rates in recent years, common use of NGS molecular testing technique, and the majority of pts having first specimen collected for molecular testing prior to 1L Tx initiation reflect physicians' intention to leverage molecular data to better inform Tx decisions. The subset of pts with second specimen collected for molecular testing after 2 weeks of 1L Tx initiation suggests some physicians' efforts to evaluate new and/or persistent targeted stable mutations."

Clinical • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IDH1 • IDH2