CAR T-cell Therapy

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

The FDA has cleared an investigational new drug application for the first-of-its-kind, off-the-shelf CAR T-cell product FT819, which targets CD19-positive malignancies.

Paul J. Shaughnessy, MD, discusses the available CAR T-cell therapies for relapsed/refractory hematologic malignancies.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Advances of chimeric antigen receptor T-cell therapy technologies are in rapid development and under investigation in a range of preclinical and clinical research around the globe.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.

Nikhil C. Munshi, MD, discusses the next steps for research with idecabtagene vicleucel in relapsed/refractory multiple myeloma.

Natalie Sophia Grover, MD, discusses ongoing research with CAR T-cell therapy in hematologic malignancies, efforts examining the potential for this approach in solid tumors, and future directions and challenges with this modality.

Caron Jacobson, MD, discusses the initial ZUMA-5 findings and the next steps with axicabtagene ciloleucel in follicular lymphoma and marginal zone lymphoma.

Findings from an exploratory analysis of the phase 1/2 ZUMA-1 trial demonstrated clinical efficacy in patients with relapsed/refractory large B-cell lymphoma who were retreated with the CAR T-cell therapy axicabtagene ciloleucel.

Jesus G. Berdeja, MD, further discusses other exciting trials in multiple myeloma and CAR T therapy being presented at the 2020 ASCO Virtual Scientific Program.

Patients with relapsed chronic lymphocytic leukemia and B-cell lymphoma who received the anti-CD19 CAR T-cell therapy FMC63-28Z experienced highly durable rates of remission, according to long-term data from a phase 1/2 study.

The allogeneic CAR-T cell therapy ALLO-501, paired with the monoclonal antibody ALLO-647, demonstrated clinical responses and manageable toxicity in patients with pretreated large B-cell and follicular lymphomas.

The chimeric antigen receptor T-cell therapy, JNJ-4528, continued to demonstrate deep and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma, according to updated findings from the phase 1b/2 CARTITUDE-1 (NCT03548207) trial.

Tisagenlecleucel led to clinically meaningful and durable improvements in health-related quality of life in patients with relapsed/refractory diffuse large B-cell lymphoma who achieved a complete or partial response to the CD19-directed CAR T-cell therapy in the phase 2 JULIET trial.