Hematologic Oncology

The BLA seeking approval for remestemcel-L for children with steroid-refractory acute graft-vs-host-disease has been resubmitted to the FDA.

BGB-16673-101 (NCT05006716) is a phase 1 study of a bruton tyrosine kinase degrader (BGB-16673) in patients with relapsed or refractory CLL/SLL.

DREAMM-8 (NCT04484623) is an ongoing, randomized, open-label, phase 3 study evaluating BPd vs PVd in patients with RRMM previously treated with ≥1 line of therapy including lenalidomide.

Dr. Choe discusses the potential role of the CSF-1R signaling pathway in the pathogenesis of numerous diseases, including GVHD. A video segment explores how dysregulation of this pathway can contribute to the development and progression of GVHD, providing the rationale for targeting CSF-1R as a potential therapeutic strategy.

In this video, Dr. Hannah Choe provides an overview of the background of graft-versus-host disease (GVHD), discusses currently approved treatments and their limitations, and the significant unmet treatment needs in GVHD.

Selinexor has received approval as monotherapy for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma in China.

KT-333 was well tolerated in relapsed/refractory hematologic and solid tumor cancers, including cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

The study assessed the comparative efficacy of zanubrutinib vs acalabrutinib in patients with R/R MCL, in the absence of head-to-head clinical trials, using population-adjusted indirect treatment comparison via simulated treatment comparison approach. Data source for the efficacy of zanubrutinib was informed by the pooled individual patient-level data from 2 clinical trials: BGB-3111-206 (NCT03206970) and BGB-3111-AU-003 (NCT02343120). The efficacy of acalabrutinib was informed by the published aggregated data of the ACE-LY-004 trial (NCT02213926).

Here is your guide to the important regulatory decisions made by the FDA in June 2024.

Hua-Jay “Jeff” Cherng, MD, discusses efficacy and safety considerations for the use of bispecific antibodies in patients with DLBCL.

Naval G. Daver, MD, discusses updated findings from a phase 1/2 study of the menin-MLL inhibitor DSP-5336 in relapsed/refractory acute leukemias.

DREAMM-7 (NCT04246047) is a global, randomized, open-label, phase III head-to-head trial evaluating the efficacy and safety of BVd triplet vs SoC triplet, DVd, in patients (pts) with RRMM with ≥1 prior line of therapy.

Joseph Maakaron, MD, discusses factors that influence his decision to use bispecific antibodies or CAR T-cell therapy in patients with DLBCL.

The FDA has modified the risk evaluation and mitigation strategies for CAR T-cell therapies approved for hematologic malignancies.

Liso-cel continued to show improved disease control and EFS and PFS vs SOC in the second-line treatment of patients with large B-cell lymphoma.

Marie Hu, MD, discusses her decision-making process when considering bispecific antibodies vs CAR T-cell therapy in patients with DLBCL.

The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

Harry Erba, MD, PhD, discusses the safety profile of quizartinib according to treatment phase and age in newly diagnosed patients with FLT3-ITD–positive acute myeloid leukemia.

Radhika Bansal, MBBS, discusses outpatient administration of axi-cel and brexu-cel in relapsed/refractory non-Hodgkin lymphoma.

IMROZ (NCT03319667) is the first global Phase 3 study of an anti-CD38 mAb in combination with VRd in patients with transplant-ineligible NDMM.

Allison Winter, MD, discusses unmet needs for patients with Richter transformation from CLL.

Andrew Ip, MD, discusses alternative splicing of the TNFRSF17 gene, which encodes BCMA, in patients with lymphoma or multiple myeloma.

The FDA has approved crovalimab for patients 13 years of age and older with paroxysmal nocturnal hemoglobinuria and a body weight of at least 40 kg.

Eric Winer, MD, discusses the rationale for the phase 1/2a TakeAim Leukemia trial of emavusertib in patients with R/R FLT3- and spliceosome-mutated AML.

Monzr M. Al Malki, MD, discusses outcomes with mismatched unrelated donor transplantation using post-transplant cyclophosphamide–based GVHD prophylaxis.