Patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (iNHL) have begun treatment with axicabtagene ciloleucel (axi-cel) in the Phase 2 ZUMA-5 trial, the immunotherapy’s developer, Kite Pharma, announced. The trial (NCT03105336) is currently recruiting participants in the U.S.
Kite, a leading player in the field of cell therapy, is continuing its studies of axi-cel after positive results in an earlier clinical study published in the journal Blood.
The research, “B-cell Depletion and Remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells,” reported a high response rate and increased disease remission in patients with relapsed or refractory iNHL who received treatment with axi-cel (NCT00924326).
Axi-cel is an investigational therapy for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant, a type of transplant that uses a person’s own stem cells.
In this type of treatment, patients’ T-cells, an important group of cells in our immune system, are removed and modified to express the chimeric antigen receptor (CAR) targeting CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemia. This strategy redirects T-cells against cancer cells so that they can recognize and kill diseased cells once reintroduced into patients.
Currently, the U.S. Food and Drug Administration (FDA) is reviewing axi-cel for aggressive non-Hodgkin’s lymphoma. The therapy already has received breakthrough therapy designation for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).
The Phase 2 ZUMA-5 trial aims to enroll 50 adult patients with iNHL whose disease relapsed within two years of first-line treatment, is refractory to second-line or greater therapy, or has relapsed at any point after transplant. The trial will determine patients’ response to treatment with axi-cel and assess if the therapy is safe. The primary endpoint will evaluate patients’ objective response rate, with researchers targeting a rate of 70%.
“Despite recent advances in the treatment of NHL, iNHL generally remains an incurable disease. As a result, there is a great unmet need in patients with high-risk disease which is why the focus of this study has the opportunity to make a difference,” David Chang, MD, PhD, executive vice president of research and development and chief medical officer at Kite, said in a press release. “The dosing of the first patient in ZUMA-5 marks an important milestone in our commitment to serving patients. We will continue to explore the potential for axi-cel to treat hematologic malignancies beyond aggressive NHL, the foundation of our CAR-T program.”