daunorubicin / Generic mfg. - LARVOL DELTA

Revumenib Plus Intensive Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia Harboring Genetic Alterations in KMT2A , NPM1 , or NUP98 : Updated Phase 1 Results From SNDX-5613-0708 (SOHO 2026) - P1, P3 | "Design: Following induction with cytarabine and daunorubicin or idarubicin, enrolled patients (patient/caregiver consent) were administered either 110/220 mg (DL1) or 160/270 mg (DL2) revumenib ± a strong CYP3A4 inhibitor. Revumenib plus IC demonstrated a manageable safety profile across both DLs, comparable to IC alone, with no new safety signals. Preliminary efficacy data suggest deep responses with high MRD− CR rates, supporting continued evaluation of revumenib in the phase 3 REVEAL-ND NPM1 trial (NCT07211958). CR: complete response, CYP3A4: cytochrome P450 3A4, FLT3: fms related receptor tyrosine kinase 3, HSCT: hematopoietic stem cell transplantation, KMT2A: lysine methyltransferase 2A, NPM1: nucleophosmin 1, NUP98: nucleoporin 98 and 96 precursor, ORR: objective response rate."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • KMT2A • NPM1 • NUP98

Pembrolizumab and Radiation Therapy With or Without Neoadjuvant Doxorubicin and Ifosfamide for the Treatment of High-Risk Resectable Undifferentiated Pleomorphic Sarcoma or Liposarcoma of the Extremity or Trunk Wall (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Ohio State University Comprehensive Cancer Center

New P3 trial • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas (clinicaltrials.gov) - P3 | N=365 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2035 ➔ Apr 2032 | Trial primary completion date: Jun 2035 ➔ Apr 2032

Trial completion date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

GILTERITINIB VERSUS MIDOSTAURIN IN PATIENTS WITH NEWLY DIAGNOSED FLT3-MUTATED ACUTE MYELOID LEUKEMIA ELIGIBLE FOR INTENSIVE THERAPY: RESULTS FROM THE PHASE 3 HOVON156/AMLSG28-18/PASHA TRIAL (EHA 2026) - P3 | "Pts were randomized to induction chemo (cycle 1: standard 7+3 [cytarabine + anthracycline]; cycle 2: daunorubicin + intermediate-dose cytarabine) + either oral GILT (120 mg once daily) or MIDO (50 mg twice daily) on days 8–21. Consolidation for pts in complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) consisted of chemo (intermediate-dose cytarabine or mitoxantrone/etoposide) + GILT or MIDO; or autologous/allogeneic hematopoietic stem cell transplantation (auto/alloHSCT) with GILT or MIDO maintenance for 1 y. Eligible pts (≥18 y) had ND FLT3 mut+ AML, ECOG PS ≤2 and were fit for intensive chemo...Summary/Conclusion Survival outcomes for GILT were not significantly different from MIDO in ND FLT3 mut+ AML, thus the primary endpoint was not met. A clinically meaningful RFS advantage with GILT vs MIDO did not translate into an OS benefit, likely due to more frequent use of GILT and alloHSCT as salvage therapy..."

Clinical • Late-breaking abstract • P3 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • FLT3 • NPM1

Exposure-Response Analysis of Ziftomenib Combined With Venetoclax/Azacitidine or Cytarabine/Daunorubicin in Newly Diagnosed and Relapsed/Refractory NPM1-M or KMT2A-R Acute Myeloid Leukemia (SOHO 2026) - P1 | "No significant ER relationship for efficacy or safety was observed across ziftomenib doses of 200–600 mg QD combined with ven/aza or 7+3 in NPM1-m or KMT2A-r patients, demonstrating a wide therapeutic margin for ziftomenib. The lack of clinically meaningful drug-drug interaction supports coadministration of the combination agents without dose adjustments. Taken together with overall safety, efficacy, PK, and pharmacodynamic data, these findings support ziftomenib 600 mg QD as the optimal dose in combination with standard-of-care ven/aza or 7+3, providing the best benefit/risk outcomes in NPM1-m or KMT2A-r patients."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1

Venetoclax-based regimens versus intensive chemotherapy in fit older adults with newly diagnosed acute myeloid leukemia (AML):a multicenter, prospective, randomized phase II trial (ASH 2025) - P=N/A | "Thismulticenter, randomized phase II study (NCT06066242) compared efficacy and safety of differentinduction therapies. Patients aged 60–75 years with newly diagnosed, non-M3/CBF AML fit for IC were randomized1:1:1 (Oct 2023–Jan 2025) to: Arm A (IC): Standard "3+7" (D/IA: daunorubicin 60mg/m² or idarubicin 10mg/m² d1-3, cyctarabine 100mg/m² d1-7)Arm B (VA): Ven (100mg d1, 200mg d2, 400mg d3-21/28; on day21, a bone marrow aspiration will be performed...Two cycles of intermediate-dose cytarabine consolidation(cyctarabine 1g/m² q12h d1,3,5), followed by maintenance: 2 cycles of DA/IA (daunorubicin 30mg/m² oridarubicin 8mg/m² d1-2, cyctarabine 100mg/m² d1-5) and 4 cycles of VA (Ven 400mg d1-7, AZA 75mg/m²d1-5)... No significant differences in survival were observed across three regimens. CRc rates weresimilar between VA and D/IAV regimen, which shows trend better than D/IA. VA improvedsurvival compared to D/IA in..."

Clinical • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Neutropenia

VA vs DA for Newly Diagnosed Hig-risk AML (clinicaltrials.gov) - P2/3 | N=116 | Recruiting | Sponsor: The First Affiliated Hospital of Soochow University | Trial completion date: Oct 2027 ➔ May 2028 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Updated response and safety analyses from a Phase 1 study of ivosidenib combined with intensive chemotherapy in patients with newly diagnosed (ND) Acute Myeloid Leukemia with isocitrate dehydrogenase (IDH)1 mutation (ASH 2025) - P1, P3 | "Introduction Ivosidenib (IVO) is approved as monotherapy and in combination with azacitidine for frontline treatmentof patients (pts) with mIDH1 acute myeloid leukemia (AML) unfit for intensive chemotherapy (chemo)...Pts with ND mIDH1AML received induction therapy: cytarabine 200 mg/m2/d × 7 d and either daunorubicin 60 mg/m2/d oridarubicin 12 mg/m2/d × 3 d (up to 2 cycles of induction were permitted) and IVO 500 mg once dailystarting on d 1 of induction therapy...IVO maintenance has an acceptable safety profile, is associated with stablenormalization of blood counts, and results in durable responses and long-term survival acrosscomutational profiles. The benefit of this frontline regimen is being assessed in a phase 3 randomized,blinded trial (NCT03839771)."

Clinical • P1 data • Acute Kidney Injury • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Renal Disease • Thrombocytopenia • TP53

10 Year Follow-up of CALGB 10603/Ratify: Midostaurin Versus Placebo Plus Intensive Chemotherapy in Newly Diagnosed FLT3 Mutant Acute Myeloid Leukemia Patients Aged 18-60 Years (ASH 2024) - "Subsequently, additional targeted drugs including gilteritinib for relapsed/refractory FLT3-mutant AML and quizartinib plus chemotherapy in untreated adults with AML with FLT3-ITD disease have gained approval...Methods : C10603 enrolled 717 pts (360 on the M and 357 on the P arm; median age 47.8 years (range 18-61), 398 women (55.5%) of whom 51.7% were randomized to M and 59.4% to P (p=0.04), and 89% white) from 2011-2015 with previously untreated AML who had either a FLT3-TKD or ITD mutation with allelic ratio of >0.05 to receive daunorubicin/cytarabine (3+7) induction (one reinduction permitted) followed by up to 4 consolidation cycles with cytarabine 3 g/m2 every 12h on days 1, 3 and 5...Conclusions : The EFS benefit of randomization to midostaurin vs placebo when added to chemotherapy was maintained over time, although the benefit for OS was diminished, likely due in part to aging. Patient and disease factors differed between early vs late relapses, which could..."

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

BRAF-Mutated Acute Myeloid Leukemia (AML) Represents a Prognostically Poor Subgroup Enriched for Myelodysplasia-Related Subtypes and Distinct from Other RAS Pathway Mutant AML (ASH 2024) - "Clinically, BRAFm pts were treated with high-intensity (HI)+/-venetoclax (VEN), [n=15, 42%], low intensity [LI, n=10, 29%] or LI+VEN [n=10, 29%] regimens...Analysis of a control cohort of MR-AML pts with (n=129) and without (n=403) RAS pathway mutations treated on cytarabine/daunorubicin-based frontline protocols revealed no survival difference between mutated and wild-type pts...Our profiling results suggest that while BRAFm AML may harbor a RAS pathway addiction, BRAF mutations have distinct impacts compared to other RAS pathway mutations. Our findings highlight the need to further understand the role of BRAF mutations in AML pathogenesis and assess the utility of novel therapeutic strategies in BRAFm AML."

Tumor mutational burden • Acute Myelogenous Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Psychiatry • ASXL1 • BRAF • CD34 • FLT3 • ITGAM • KRAS • NRAS • PTPN11 • TET2 • TMB

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=39 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Updated Results of POLARIS-1 (Part 1), a Global Registrational Phase 3 Study: Olverembatinib Combined With Low-Intensity Chemotherapy in Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (SOHO 2026) - P3 | "Induction included vincristine, dexamethasone, ±daunorubicin for 3 cycles. Consolidation alternated 3 cycles of high-dose methotrexate with 3 cycles of cytarabine; maintenance continued for 12 cycles... Olverembatinib plus reduced-intensity chemotherapy achieved 63.0% MRD-negative CR in ND Ph+ ALL, including patients with inferior prognostic genotypes, with a favorable safety profile. ALL: acute lymphoblastic leukemia, BCR::ABL1: breakpoint cluster region–Abelson 1, CR: complete response, CRi: complete response with incomplete blood count recovery, ECOG PS: Eastern Cooperative Oncology Group performance status, EOI: end of induction, HSCT: hematopoietic stem cell transplantation, MRD: measurable residual disease, ND: newly diagnosed, Ph+: Philadelphia chromosome–positive, qPCR: quantitative polymerase chain reaction, TEAE: treatment-emergent adverse event. Funding: Ascentage Pharma Group Corp Ltd (Hong Kong)."

Clinical • P3 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • IKZF1

Gilteritinib Results in Higher Remission and Transplant Rates Than Midostaurin but Does Not Increase the Post-Induction Mutational MRD Negative Rate: Results of the Phase 2 Randomized Precog 0905 Study in Newly Diagnosed FLT3 Mutated AML (ASH 2024) - "Induction consisted of cytarabine 100 mg/m2 by continuous infusion daily, on day (d) 1-7 and daunorubicin 90 mg/m2 IV on d 1-3. Future survival data will help evaluate the clinical impact of G and MRD assessments in ND FLT3mAML. Larger studies will be needed to establish most predictive timing of MRD and for definitive comparisons of these drugs in patients with specific mutation profiles ( ie TKD, ITD/NPM1/DNMT3)."

Clinical • Minimal residual disease • P2 data • Acute Myelogenous Leukemia • Transplantation • DNMT3A • FLT3 • NPM1

MRD-positive AML Clinical Study (clinicaltrials.gov) - P=N/A | N=537 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=120 ➔ 537 | Trial completion date: Apr 2028 ➔ Oct 2028 | Trial primary completion date: May 2026 ➔ May 2028

Enrollment change • Minimal residual disease • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • DEK • FLT3 • NPM1 • NUP214 • RUNX1 • RUNX1T1

Venetoclax combined with daunorubicin and cytarabine (2 + 6) in acute myeloid leukemia: Updated results of a phase II trial. (PubMed, Hematol Oncol) - No abstract available

Journal • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Comparative Toxicity of Menin Inhibitor–Based Combination Therapy in Newly Diagnosed Acute Myeloid Leukemia: Venetoclax-Containing Versus Non-Venetoclax Regimens (SOHO 2026) - "BEAT AML trial (revumenib+venetoclax+azacitidine; n = 43; median age, 73 years; unfit for intensive chemotherapy) reported these rates: differentiation syndrome, 19% for any grade, grade ≥3 in 5% (2/43); QTc prolongation, 44% for any grade, grade 3 in 12% (5/43); febrile neutropenia, grade ≥3 in 26% (11/43); treatment discontinuation, 0%; early mortality, 7% (3/43, sepsis/respiratory failure)...Non-venetoclax regimens: KOMET-007, 7+3 (ziftomenib+cytarabine/daunorubicin) group (n = 51; median age, 59 years; fit patients) reported these rates: differentiation syndrome, 0%; febrile neutropenia, grade ≥3 in 47% (24/51)... Venetoclax-based menin inhibitor combinations demonstrated significantly lower febrile neutropenia, compared with intensive chemotherapy, and manageable differentiation syndrome. No differentiation syndrome with 7+3 likely reflects delayed menin inhibitor initiation after cytoreduction. Cross-trial comparisons are limited by heterogeneous populations, small..."

Combination therapy • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1

DNMT3A as an Epigenetic Scaffold in Acute Myeloid Leukemia: Synergistic Mutational Landscapes and Therapeutic Implications (SOHO 2026) - "In Patient 1, the identification of IDH2 allowed for a triple combination therapy (azacitidine/venetoclax+enasidenib), successfully achieving clinical remission after intensive chemotherapy failure. : Our findings emphasize that DNMT3A mutations serve as a critical epigenetic scaffold for secondary mutations. Comprehensive NGS profiling identifies these synergistic clusters, enabling a shift from standard 7+3 protocols to personalized, targeted combinations (eg, IDH inhibitors) that can overcome epigenetic block in relapsed/refractory AML. 7+3: cytarabine given daily for 7 days and daunorubicin given daily for 3 days, AMP: Association for Molecular Pathology, ASCO: American Society of Clinical Oncology, CAP: College of American Pathologists, CGC: Cancer Genomics Consortium, ClinGen: Clinical Genome Resource, DNMT3A: DNA methyltransferase 3 alpha, FLAG-IDA: fludarabine, cytarabine, granulocyte colony–stimulating factor plus idarubicin, IDH1/2: isocitrate dehydrogenase 1..."

Acute Myelogenous Leukemia • Breast Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • DNMT3A • IDH1 • IDH2 • NPM1 • TET2 • TP53

FLAG-Ida Combined with Gemtuzumab Ozogamicin (GO) Improves Event Free Survival in Younger Patients with Newly Diagnosed Acute Myeloid Leukaemia (AML) and Shows an Overall Survival Benefit in NPM1 and FLT3 mutated Subgroups. Results from the UK NCRI AML19 Trial (ASH 2022) - "The MRC AML15 trial suggested a higher response rate and reduced relapse risk with FLAG-Ida compared to a Daunorubicin-araC (DA) +etoposide but did not show an overall survival (OS) benefit (Burnett, JCO,2013,31,3360). Furthermore this survival benefit was associated with a reduction in the requirements for transplant in CR1 and overall. Given the benefit observed in FLT3 mutated AML in the absence of a FLT3 inhibitor, studies combining FLAG-Ida-GO with Midostaurin are warranted."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • FLT3 • NPM1

REVUMENIB + INTENSIVE CHEMOTHERAPY FOR NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA HARBORING GENETIC ALTERATIONS IN KMT2A, NPM1, OR NUP98: UPDATED PHASE 1 RESULTS FROM SNDX-5613-0708 (EHA 2026) - P1, P3 | "Two dose levels (DL) of revumenib were evaluated (DL1: 110 mg/220 mg ± strong CYP3A4 inhibitor [CYP3A4i]; DL2: 160 mg/270 mg ± strong CYP3A4i) in combination with cytarabine plus daunorubicin or idarubicin. These findings support continued evaluation of revumenib + IC in the phase 3 REVEAL-ND NPM1 trial in fit pts with NPM1 m AML (NCT07211958). Updated results will be presented."

P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • FLT3 • KMT2A • NPM1 • NUP98

ACCRU-LY-1601: Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=83 | Active, not recruiting | Sponsor: Academic and Community Cancer Research United | Trial completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Venetoclax plus Daunorubicin and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia: Results of a Phase 1b Study. (PubMed, Blood) - P1 | "Ven dose optimization is being explored in the expansion phase of this trial. Future multicenter studies should confirm our findings."

Journal • P1 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock

Survival and Toxicity Trade-Offs With Anthracycline-Based Induction vs Non-Anthracycline Therapy in Newly Diagnosed Acute Myeloid Leukemia: A Real-World Propensity-Matched Analysis (SOHO 2026) - "Anthracycline cohort (n = 9727): daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone. Nonanthracycline cohort (n = 6649): azacitidine, decitabine, venetoclax, glasdegib, gilteritinib, enasidenib, ivosidenib, midostaurin; anthracyclines excluded... Anthracycline induction was associated with 27% lower 3-year mortality but higher acute toxicity—36% more hospitalization, 23% bleeding, 13% VTE, 11% MACE—reflecting the risk-benefit profile of intensive induction. Selection of fitter patients with favorable AML biology likely contributes through residual confounding despite PSM. These findings reinforce integrating fitness, cytogenetic/molecular risk, and patient preference into the frontline regimen choice."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

Outcome of Remission Induction Using Intensive Chemotherapy or Hypomethylating Agents With Venetoclax in Newly Diagnosed Acute Myeloid Leukemia (SOHO 2026) - "Interventions: The IC group received daunorubicin (45–50 mg/m2 for 3 days) and cytarabine (100 mg/m2 for 7 days). The HMA/Ven group received venetoclax (400 mg for 28 days) with decitabine (20 mg/m2) or azacitidine (75 mg/m2) for 7 days... Both IC and HMA/Ven achieved comparable ORRs. Although IC provided superior early hematologic recovery, HMA/Ven demonstrated noninferiority, offering an effective modality for younger and fit patients in resource-constrained settings. Larger comparative prospective studies are required to validate findings."

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

Safety and Efficacy of Combining Midostaurin and Gemtuzumab Ozogamicin with Induction Chemotherapy in FLT3 mutated AML. (PubMed, Blood Adv) - "We evaluated the safety and efficacy of the combination of daunorubicin, cytarabine (DA), gemtuzumab ozogamicin (GO) and midostaurin (DAGO+m) for younger patients with newly diagnosed FLT3mut AML in the UK NCRI AML19 trial...DAGO2+m will now be evaluated in a randomised study (OPTIMISE-FLT3, ISRCTN 34016918). Trial: ISRCTN78449203."

Journal • Acute Myelogenous Leukemia • Transplantation • FLT3 • NPM1

BRAF-Mutated Acute Myeloid Leukemia (AML) Represents a Distinct, Prognostically Poor Subgroup Enriched in Myelodysplasia-Related (MR-)AML (ASH 2023) - P, P=N/A | "Pts were treated with low intensity [LI, n=10 (29%); LI+venetoclax (VEN, n=10 (29%)], high-intensity [HI, n=12 (34%) or HI+VEN, n=3 (9%)] regimens...A comparison of a control cohort of MR-AML pts with (n=129) and without (n=403) RAS pathway mutations treated on cytarabine/daunorubicin-based frontline protocols, revealed no survival difference between RAS-mutated and wild-type pts, suggesting a negative survival impact specific to BRAF-carrying leukemic clones...This suggests the need to assess the utility of BRAF inhibitors and/or RAS pathway-targeting regimens such as MEK inhibitors in pts with AML carrying BRAF mutations. Support: U10CA180821, U10CA180882, U24CA196171; Clinicaltrials.gov: NCT00048958 (CALGB 8461), NCT00899223 (CALGB 9665), NCT00900224 (CALGB 20202)"

Tumor mutational burden • Acute Myelogenous Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Psychiatry • ASXL1 • BRAF • DNMT3A • FLT3 • KRAS • NPM1 • NRAS • PTPN11 • RUNX1 • SRSF2 • TET2 • TMB