AML

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.

A phase II trial of ficlatuzumab, an investigational HGF inhibitory antibody, in patients with relapsed and refractory acute myeloid leukemia joins the growing list of clinical trials halted due to the coronavirus disease 2019 pandemic.

Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.

Researchers have developed a baseline score to determine the risk for heart failure in patients with acute leukemias, to address the scarcity in knowledge around the increasing incidence and risk factors of symptomatic heart failure in this patient population. The findings were published in JACC: CardioOncology.

Courtney D. DiNardo, MD, MSCE, discusses what is on the horizon for the acute myeloid leukemia setting.

After demonstrating promising results that were comparable to targeted therapies in the first 2 cohorts of a phase I clinical trial, the combination of cladribine, cytarabine, granulocyte-colony stimulating factor, and mitoxantrone plus the antibody radiation conjugate lintuzumab-Ac225 in patients with relapsed/refractory acute myeloid leukemia is now being explored in a third cohort.

The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.

In an interview with <em>Targeted Oncology</em>, Rajneesh Nath, MD, discussed the background and rationale for the phase III SIERRA trial. He also explained what this research means for the treatment landscape of acute myeloid leukemia.&nbsp;

Courtney D. DiNardo, MD, MSCE, explains the rationale for the phase II AG221-AML-005 trial.

Following the FDA approval of gemtuzumab ozogamicin with induction and consolidation therapy in newly diagnosed CD33-positive acute myeloid leukemia, investigators led by Richard F. Schlenk, MD, hypothesized that patients with NPM1-mutated acute myeloid leukemia,&nbsp;which occurs in 20% to 30% of the patient population,&nbsp;could also derive benefit from gemtuzumab.

The autologous dendric cell vaccine targeting Wilms tumor-1 antigens with or without preferentially Expressed Antigen in Melanoma was well tolerated and feasible in patients with acute myeloid leukemia, meeting the co-primary end points of the phase I/II clinical trial.

Adam Fisch, MD, PhD, a clinical fellow in molecular genetic pathology at the Brigham&rsquo;s Women&rsquo;s Hospital, discusses the key points from a patient case he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo, in which the patient with acute myeloid leukemia harboring a FLT3-TKD mutation lost the mutation following relapse on gilteritinib.

In an interview with&nbsp;Targeted Oncology, Courtney D. DiNardo, MD, discussed the interim analysis results from the ongoing phase II trial evaluating the combination of enasidenib plus azacitidine in newly diagnosed patients with acute myeloid leukemia.

Results from a phase I/Ib trial showed revealed that preliminary activity was seen with IMGN632, an investigational anti-CD123 antibody-drug conjugate, given to patients with relapsed/refractory acute myelogenous leukemia or blastic plasmacytoid dendritic cell neoplasm, according to data presented at the 2019 ASH Annual Meeting.

Rapidly Progressing Acute Myeloid Leukemia

Naval Daver, MD, explains the rationale for the phase II QUAZAR trial, which assessed the efficacy and safety of azacitidine in patients with acute myeloid leukemia.

In an interview with&nbsp;Targeted Oncology, Pinkal Desai, MD, discussed the latest advancements in the treatment landscape for patients with AML, particularly for the older population. She also highlighted emerging treatment options that undergoing investigation now in clinical trials.