ASH 2016: KTE-C19 in Patients With Chemorefractory Primary Mediastinal B-Cell Lymphoma and Transformed Follicular Lymphoma
Immune cellular therapy is a promising new area of cancer treatment. Anticancer therapeutics, such as chimeric antigen receptor (CAR) modified T cells, can be engineered to target tumor-associated antigens to attack and kill cancer cells. Moffitt Cancer Center physician-scientist Fredrick L. Locke, MD, presented interim results from cohort 2 of the phase II portion of the ZUMA-1 study, which used CAR-T therapy for patients with refractory primary mediastinal B-cell lymphoma and transformed follicular lymphoma, during the 2016 American Society of Hematology (ASH) Annual Meeting in San Diego (Abstract 998).
The ZUMA-1 study utilized KTE-C19, which is an autologous CAR T-cell therapy. During KTE-C19 CAR T-cell therapy, T cells are isolated from a patient's blood and genetically engineered in the laboratory to target the CD19 protein that is found on lymphoma cells. The genetically engineered T cells are then infused back into the patient. The KTE-C19 T cells are able to recognize cancerous lymphoma cells that express CD19 and target them for destruction.
The phase I portion of the ZUMA-1 study revealed that KTE-C19 was tolerable and produced ongoing remissions in B-cell non-Hodgkin lymphoma patients (Locke et al, Abstract 1048O, ESMO Congress 2016).
Phase II ZUMA-1 Findings
The phase II portion of the study consists of two cohorts: cohort 1 for patients with chemorefractory diffuse large B-cell lymphoma and cohort 2 for patients with chemorefractory primary mediastinal B-cell lymphoma or transformed follicular lymphoma.
As of June 16, 2016, 6 patients with refractory primary mediastinal B-cell lymphoma or transformed follicular lymphoma were treated in cohort 2 with KTE-C19. The patients were highly refractory to prior treatments and included 3 patients who were refractory to second-line or greater therapy and 3 patients who relapsed after autologous stem cell transplants.
KTE-C19 therapy resulted in promising clinical activity in these patients. With a median follow-up period of 3.2 months, all 6 patients achieved a complete remission.
KTE-C19 treatment also resulted in manageable toxicities that were generally reversible. Grade 3 treatment-emergent adverse events occurred in 17% of patients, and grade 4 treatment-emergent adverse events occurred in 67%. All 6 patients experienced cytokine release syndrome; however, all cases were grade 1 or 2. Neurotoxicity occurred in 67% of patients, and 33% of the cases were grade 3.
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