AML

Now that the FDA has lifted the partial clinical hold on the phase 1 study of FHD-286 in patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome, there are plans to initiate a trial to further assess the agent with decitabine or cytarabine.

When used as a monotherapy or in combination with venetoclax, voruciclib was generally well tolerated and showed an encouraging preliminary efficacy signal in patients with acute myeloid leukemia or B-cell malignancies.

Brian A. Jonas, MD, discusses studies investigating the use of uproleselan for the treatment of patients with acute myeloid leukemia.

Results from the phase 3 QuANTUM-First study create a position for quizartinib plus chemotherapy in the FLT3-ITD-positive acute myeloid leukemia armamentarium.

The new Prescription Drug User Fee Act action date for quizartinib for use in patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia has been set to July 24, 2023.

Eytan M. Stein, MD, provides community oncologists with an overview of the unmet needs in the acute myeloid leukemia space and provides recommendations for those treating patients with this disease.

The next-generation anthracycline Annamycin has been administered to the first patient with relapsed/refractory acute myeloid leukemia in combination with cytarabine in a phase 1/2 study.

One of the key tools used to detect leukemic cells is measurable residual disease, formerly referred to as minimal residual disease.

Courtney D. DiNardo, MD, MSCE, provided an overview of venetoclax resistance and interrelated mechanisms, with a spotlight on kinase signaling pathways, TP53 mutation, monocytic, and other forms of resistance.

The inaugural participant with AML showing a mutation of FLT3 in a relapsed/refractory form has been recruited into the Phase 1 FRIDA trial.

A patient who received AB8939, a microtubule inhibitor, in a phase 1 study, had a significant reduction in bone marrow blasts, showing its potential to treat drug-resistant acute myeloid leukemia.

Preclinical and phase 1/2a data evaluating the safety and tolerability of EP0042 in patients with relapsed or refractory acute myeloid leukemia has led the FDA to grant an orphan drug designation to the agent.

In an interview with Targeted Oncology, Brian A. Jonas, MD took a close look at the precision medicine landscape for AML and discussed key biomarkers and research needs for the future.

Brian A. Jonas, MD, PhD, discusses novel biomarkers being explored in acute myeloid leukemia, including e-selectin, which Jonas believes is very promising.

Early data of the Orca-T cellular therapy showed enough positive results from patients on the therapy to move on to a phase 3 study in this patient population.

The independent Data Monitoring Committee recommends the phase 3 study evaluating treatment with uproleselan in patients with relapsed/refractory acute myeloid leukemia to continue to the original planned final overall survival events trigger.

Patients with acute myeloid leukemia given annamycin demonstrated tolerable safety and preliminary efficacy with the agent, according to topline results from a phase 1/2 study.

In the phase 3 ETAL3-ASAP trial, patients with relapsed/refractory acute myeloid leukemia given an allogeneic hematopoietic cell transplant had similar overall survival rates vs those given intense salvage chemotherapy first.

In phase 1 of the KOMET-001 trial, ziftomenib showed a 30% complete response rate in patients with NPM1-mutant acute myeloid leukemia treated at a dose of 600 mg. This is now the recommended phase 2 dose for the phase 2 portion of the study.

Updated findings from a phase 2 study have further confirmed the benefit of olutasidenib when used as a treatment option for patients with IDH1-mutant relapsed/refractory acute myeloid leukemia.

Jorge E. Cortes, MD, provides an overview of the background and findings of the phase 1/2 Study 2102-HEM-101 of olutasidenib in patients with relapsed/refractory IDH1-mutated acute myeloid leukemia.

The novel FLT3 inhibitor, tuspetinib, will be investigated further in patients with FLT3-positive acute myeloid leukemia.

The latest patient enrolled in cohort 3 of the phase 1/2 MGTA-117 trial experienced a grade 5 serious adverse event resulting in death. The study has been halted to investigate the safety of the agent.

After the FDA cleared an investigational new drug application for mocravimod in April 2022, the first patients with acute myeloid leukemia undergoing allogeneic hematopoietic cell transplant have been enrolled in a phase 2b/3 study of the agent.

Although the need for novel approaches to treat patients with TP53-mutated acute myeloid leukemia remains urgent, cautious optimism may be in order given recent data from clinical trials and upcoming studies.