LEUKEMIAS

The biologics license application seeking the approval of obe-cel as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.

An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.

A recent study found that CXC chemokine ligand 13 and galectin-9 could be prognostic biomarkers of progression-free survival and treatment response in patients with chronic lymphocytic leukemia.

The application for lisocabtagene maraleucel in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma has been accepted by the FDA, following positive results from the TRANSCEND CLL 004 study.

During a Targeted Oncology™ Case-Based Roundtable™ event, Nicholas Short, MD, and participants discussed which patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia they would treat with inotuzumab ozogamicin.

Bexmarilimab shows encouraging results when combined with standard of care treatments for patients with acute myeloid leukemia and myelodysplastic syndromes.

Bosutinib has a new indication in leukemia as a well as a newly-approved formulation.

Eytan M. Stein, MD, discusses trials evaluating Menin inhibitors for patients with acute leukemia and unmet needs that persist in the space.

Advances are being seen with the introduction of Menin inhibitors

With the emergence of tyrosine kinase inhibitors and targeted immunotherapies in the front line, outcomes for patients with ALL have improved. However, questions about central nervous system involvement and prophylaxis persist.

Addition of ponatinib led to a higher rate of MRD-negative complete remission vs imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia.

Further investigation into the outcomes of adolescent and young adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia when treated with pediatric-inspired regimens are warranted.

Although it is well-established that MRD negativity plays an important prognostic role in Ph-positive ALL, the optimal method to assess MRD in this disease and how to use this information therapeutically are still being established.

The current landscape for T-cell acute lymphoblastic leukemia has been influenced by 2 key phase 3 trials, Children’s Oncology Group AALL0434 and AALL1231.

Though chimeric antigen receptor T cells are showing promise in T-cell acute lymphoblastic leukemia, challenges, including those related to manufacture, those that are patient/disease specific, and those regarding risk mitigation, remain a struggle.

Utilizing the combination of inotuzuamb ozogamicin and low intensity chemotherapy, with or without blinatumoamab, showed promising results, but also an increase of patient deaths during remission.

Additional data have led to a full FDA approval for blinatumomab.

Promising data were revealed with nelarabine, intensive L-asparaginase, and protracted intrathecal therapy among patients aged 25 years and younger with T-cell acute lymphoblastic leukemia.

Findings from the phase 3 PhALLCON trial show that ponatinib plus reduced-intensity chemotherapy could be a new standard of care for patients with Philadelphia chromosome–positive acute lymphoblastic leukemia.

In a real-world population of patients with relapsed or refractory B-cell acute lymphoblastic leukemia, modest efficacy was demonstrated with brexucabtagene autoleucel.

Phase 2 FELIX study results show 21.3% of the 94 patients infused with obecatagene autoleucel achieved a complete response or complete response with incomplete count recovery.

The injectable formulation of nelarabine has been granted FDA approval to treatment 2 hematologic malignancies.

The phase 3 PhALLCON trial showed a trend toward event-free survival in patients with Philadelphia chromosome positive acute lymphoblastic leukemia when treated with ponatinib compared with imatinib.

Research shows a high occurrence of ibrutinib-related cardiotoxicity in patients with cancer. This is the first study showing such evidence.

Fadi Haddad, MD, discusses the background of a phase 2 study of blinatumomab in combination with ponatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia.