AML

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.

Updated guidelines recommend olutasidenib as a targeted therapy for patients with relapsed/refractory acute myeloid leukemia with an IDH1 mutation.

Rory Shallis, MD, discusses of the presence of the e-selectin molecule in the bone marrow and how it impacts the marrow microenvironment.

JBI-802, which is being evaluated in a phase 1/2 trial, received an orphan drug designation from the FDA for the treatment of patients with small cell lung cancer and acute myeloid leukemia.

Eytan M. Stein, MD, discusses the unmet needs and challenges for treating patients with acute myeloid leukemia.

A phase 1/2 study of uproleselan combined with chemotherapy led to a complete response of 35% and median overall survival of 8.8 months in a cohort of patients with relapsed/refractory acute myeloid leukemia.

Tapan Kadia, MD, discusses the recent and upcoming changes in treatment of acute myeloid leukemia for patients who are not candidates for intensive remission induction therapy.

Following impressive data presented at the ASH Annual Meeting, the FDA granted approval to olutasidenib or the treatment of patients with treatment-naïve and relapsed or refractory acute myeloid leukemia.

Brian Jonas, MS. PhD, discusses e-selection as a biomarker in acute myeloid leukemia, and how e-selectin inhibition works along with chemotherapy to decrease tumor growth.

Melhem M. Solh, MD, discusses results of a study investigating allogeneic stem cell transplant in patients with myelodysplastic syndrome and acute myeloid leukemia with a TP53 mutation, previously presented at the 2022 Transplantation & Cellular Therapy Meetings.

Treatment with olutasidenib induced durable remissions and a manageable adverse event profile in patients with relapsed/refractory acute myeloid leukemia who harbor IDH1 mutations.

Adding magrolimab to azacytidine and venetoclax led to a rate of high responses in high-risk de novo and secondary acute myeloid leukemia.

Comparing intensive remission induction chemotherapy prior to allogeneic hematopoietic cell transplantation to watchful waiting followed by sequential conditioning did not show superior results.

Salvage chemotherapy after lintuzumab-Ac225 showed promising early efficacy results in patients with relapsed/refractory acute myeloid leukemia by eliminating residual leukemia cells.

In an interview with Targeted Oncology, Tapan M. Kadia, MD, discussed e-selection inhibition, and other novel targets for acute myeloid leukemia therapy.

Tapan Kadia, MD, discusses potential improvements to lower intensity therapy for less fit patients with acute myeloid leukemia.

Eprenetapopt combined with azacitidine as maintenance therapy after hematopoietic stem-cell transplant induced encouraging relapse-free and overall survival in patients with TP53-mutant acute myeloid leukemia and myelodysplastic syndrome.