Acute myeloid leukemia is a cancer of the blood and bone marrow that progresses quickly and affects the production of normal blood cells. It is one of the major subtypes of acute leukemia and primarily affects adults and older adults.
Cantargia reported full year 2025 financial results with net sales of SEK 316.7 million and cash of SEK 281.8 million. The company secured a SEK 124 million financing package to advance clinical development of nadunolimab, including a phase Ib study combining it with a RAS inhibitor in pancreatic cancer.
Updated KOMET-007 trial data show ziftomenib plus chemotherapy achieves 94% twelve-month overall survival in newly diagnosed NPM1-mutant AML. The oral menin inhibitor, approved by the FDA in November 2025 for relapsed/refractory disease, is being evaluated in a Japanese Phase II trial and a global Phase 3 study.
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
The iPSC-derived NK cells pipeline includes 12+ active players and 15+ drugs in development. FT522 is in Phase I, while CNTY-101 and NCR300 are among other programs in the clinic.
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07616921 |
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant |
NOT_YET_RECRUITING | NA |
| NCT07616089 |
Phase I Study of FXS0683 in the Treatment of Blood Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07598110 |
FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML |
NOT_YET_RECRUITING | PHASE2 |
| NCT07584889 |
Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies |
RECRUITING | PHASE1/PHASE2 |
| NCT07581002 |
A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07575412 |
SHR2554/AZA + Overlapped Modified BUCY for High-risk/Relapsed Leukemia/MDS |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572929 |
A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572695 |
Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AML |
NOT_YET_RECRUITING | |
| NCT07570407 |
Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation |
NOT_YET_RECRUITING | |
| NCT07570056 |
Use of Electrical Bioimpedance in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients (Bioimpedance) |
NOT_YET_RECRUITING |
