AML

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.

The risk of relapse or death was reduced by 61% with sorafenib maintenance compared with placebo following allogeneic hematopoietic stem cell transplantation in patients with FLT3-ITD–positive acute myeloid leukemia.

In an interview with Targeted Oncology, Naval G. Daver, MD, discussed the current treatment landscape for acute myeloid leukemia and how he goes about sequencing the available agents when he treats patients in clinic.

Naval G. Daver, MD, discusses a phase 1b trial evaluating the efficacy of margolimab and azacitidine combination for patients with acute myeloid leukemia.

In an interview with Targeted Oncology, Thomas Cluzeau, MD, PhD, discussed the findings from the phase 2 study of azacitidine plus APR-246 as treatment of patients with TP53-mutant myelodysplastics syndrome and acute myeloid leukemia. He also highlighted the next steps for this treatment regimen.

A phase 3 study evaluating pracinostat in combination with azacitidine for patients with acute myeloid leukemia ineligible for standard intensive chemotherapy has been discontinued.

A new randomized placebo-controlled study finds patients with acute myeloid leukemia who cannot undergo intensive chemotherapy have improved outcomes when given venetoclax in addition to low-dose cytarabine.

During the Virtual 25th Congress of the European Hematology Association (EHA), a group of physicians described their experiences and recommendations for managing patients with myeloid malignancies during the COVID-19 pandemic and after.

Mikkael Sekeres, MD, discusses a phase 2 study of pevonedistat plus azacitidine versus azacitadine monotherapy in patients with higher-risk myelodysplastic syndromes /chronic myelomonocytic leukemia or low-blast acute myelogenous leukemia.

“While the trial is still ongoing, we are encouraged by the efficacy we are seeing thus far in patients with relapsed/refractory AML, particularly the durability of response observed in some patients."

The FDA expanded the approval of gemtuzumab ozogamicin to include an indication for the treatment of newly diagnosed pediatric patients with CD33-positive acute myeloid leukemia, which includes patients as young as 1 month old.

"The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat [patients with] TP53-mutant MDS and AML, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities,."

Courtney D. DiNardo, MD, discusses the current treatment landscape for patients with IDH1-mutated acute myeloid leukemia and how potential doublet and triplet combinations may play a role in this setting.

"AMG 330 is a CD33 BiTE® molecule under investigation in an ongoing, open-label phase I dose-escalation study and has shown preliminary activity and acceptable safety in relapsed/refractory AML patients."

Among all the treatment arms in the study, the composite complete response rate was 78% and 100% for those who were treatment-naïve for patients treated with the combination of ivosidenib and venetoclax with or without azacitidine in a phase 1b/2 study.

Rajneesh Nath, MD, discusses the early results of the phase III SIERRA trial investigating the efficacy of Iomab-B and protocol-specified allogeneic hematopoietic stem cell transplant versus the standard of care in older patients with active, relapsed or refractory acute myeloid leukemia.

"The acceptance of our submission for CC-486 represents an important step towards a potential new maintenance treatment to address an urgent medical need for patients with AML and we look forward to working with the FDA during its review of CC-486."

Rajneesh Nath, MD, discusses the rationale for phase III SIERRA trial, which evaluated the anti-CD45 monoclonal antibody apamistamab followed by fludarabine/total body irradiation and allogeneic hematopoietic cell transplantation in patients with relapsed/refractory acute myeloid leukemia.