AML

An Independent Data Monitoring Committee has recommended the pivotal phase 3 SIERRA study continue as planned to full enrollment of 150 patients based on the findings from a pre-planned ad hoc interim analysis of the study.

In a phase 1b clinical trial presented during the 2020 American Society of Hematology Annual Meeting, investigators sought to determine the efficacy and safety of the novel TIM-3–targeting IgG4 antibody sabatolimab in combination with hypomethylating agents as treatment of patients with acute myeloid leukemia, as well as high-risk myelodysplastic syndrome.

Andrew M. Brunner, MD, shares his key take home message from a phase 1b clinical trial investigating sabatolimab as treatment of patients with acute myeloid leukemia, as well as high-risk myelodysplastic syndrome.

A review by an Independent Data Monitoring Committee determined that combination of gilteritinib plus azacitidine would not likely improve overall survival compared with azacitidine alone in patients newly diagnosed FLT3-positive acute myeloid leukemia who were ineligible for intensive induction chemotherapy, missing the primary end point of the phase 3 LACEWING clinical trial.

The FDA granted a Fast Track designation to devimistat for the treatment of patients with acute myeloid leukemia.

Treatment with higher doses of CPX-351 in younger patients with newly diagnosed high-risk or secondary acute myeloid leukemia was significantly associated with prolonged hematologic recovery times during induction cycles 1 and 2.

The most important factor associated with poor survival among patients below 60 years of age with acute myeloid leukemia was self-reported black race in a SEER analysis.

In patients with acute myeloid leukemia and myelodysplastic syndrome, treatment with sabatolimab administered at 200 mg every 2 weeks and 800 mg every 4 weeks demonstrated similar pharmacokinetic activity, according to findings from a dose-selection and dose-response analysis presented during the 2020 American Society of Hematology Annual Meeting.

Treatment with a novel tri-specific natural killer cell engager agent led to natural killer cell proliferation across dose levels in patients with high-risk myelodysplastic syndromes and acute myeloid leukemia.

Azacitidine administered orally to patients with acute myeloid leukemia demonstrated significant improvements in overall survival and relapse-free survival while sustaining the health-related quality of life compared with placebo.

The addition of the oral selective RARα agonist SY-1425 to azacitidine induced clinical activity as treatment of patients with heavily pretreated relapsed/refractory acute myeloid leukemia with RARA positivity.

Significant disparities between survival outcomes of non-Hispanic white, non-Hispanic black, and Hispanic patients with acute myeloid leukemia in the Chicago metropolitan area were seen with census tract socioeconomic status information.

Patients with acute myeloid leukemia in first remission regardless of the number of rounds of prior consolidation therapy had significantly prolonged overall survival and relapse-free survival with azacitidine.

The oral, selective menin inhibtor KO-539 showed activity in preliminary findings of the ongoing first-in-human KOMET-001 trial in patients with relapsed/refractory acute myeloid leukemia.

The FDA granted a Fast Track designation to eprenetapopt as treatment of patients with TP53-mutant acute myeloid leukemia.

Brain A. Jonas, MD, discusses the future of treatment for older patients with acute myeloid leukemia, now that the FDA has granted approval to azacitidine plus venetoclax for patients aged 75 years or older.

In an interview with Targeted Oncology following the announcement of the FDA approval of azacitidine plus venetoclax in older patients with acute myeloid leukemia, Brian Jonas, MD, provided insight on the VILAE-A study results. He also gave expert advice on how to approach treating older patients with acute myeloid leukemia in every day practice.

The IDH1 inhibitor olutasidenib showed a favorable safety profile in patients with relapsed/refractory acute myeloid leukemia treated in a phase 1/2 clinical trial, according to topline results.

New guidelines from he American Society of Hematology for treating newly diagnosed acute myeloid leukemia in older patients recommend intensive antileukemic therapies over more conservative approaches.

The FDA granted approval to venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine, a regimen known as LDAC, as treatment of adults patients with aged 75 years or older with newly-diagnosed acute myeloid leukemia or who have comorbidities precluding intensive induction chemotherapy.

In an interview with Targeted Oncology Guillermo Garcia-Manero, MD, discussed the key findings from the QUAZAR AML-001 study and the importance of the FDA approval of CC-486 in post-remission acute myeloid leukemia.

The FDA granted approval to the oral hypomethylating agent, CC-486 (azacitidine tablets, Onureg), as a maintenance treatment for adult patients with acute myeloid leukemia who achieved a first complete remission or with incomplete blood count recovery after intensive induction chemotherapy and who are unable to complete intensive curative therapy.

Overall survival was not improvement with the combination of enasidenib and best supportive care compared with conventional care regimens when administered to patients relapsed/refractory IDH2-positive acute myeloid leukemia.

The FDA has granted a Fast Track designation to BST-236 for the treatment of patients with acute myeloid leukemia who are 75 years or older or have comorbidities that preclude the use of intensive induction chemotherapy.

Eunice Wang, MD, discusses the excitement she has experienced in the treatment landscape of acute myeloid leukemia over the last several years due to the number of new treatment options approved by the FDA.