More than a year after receiving the CAR T-cell therapy Yescarta (axicabtagene ciloleucel), 42 percent of the patients in the ZUMA-1 trial are still responding to the treatment, Kite Pharma announced.
The Phase 1/2 study included patients with large B-cell lymphoma whose disease had progressed following at least two prior lines of therapy. Importantly, 40 percent of patients are in complete remission after a median follow-up of 15.4 months.
The findings were recently presented at the 59th Annual Meeting of the American Society of Hematology (ASH) in a presentation titled “Long-Term Follow-up ZUMA-1: A Pivotal Trial of Axicabtagene Ciloleucel (Axi-Cel; KTE-C19) in Patients with Refractory Aggressive Non-Hodgkin Lymphoma (NHL).”
They were also published in The New England Journal of Medicine in the study, “Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma.”
“As observed in the SCHOLAR-1 study, treatment options for patients with refractory large B-cell lymphoma have yielded a median overall survival of just six months, with fewer than ten percent of patients achieving complete remission,” Sattva S. Neelapu, MD, the co-lead researcher of the ZUMA-1 trial, said in a press release.
“The durability of response seen with Yescarta in this long-term follow-up reinforces the major advance that CAR T therapy represents for these patients,” added Neelapu, who is also a professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
Yescarta is a modified T-cell therapy that uses a patient’s own T-cells and engineers them to better detect and kill cancer cells bearing the CD19 molecule at their surface. CD19 is expressed in most leukemia and lymphoma cells.
In October, the U.S. Food and Drug Administration approved Yescarta for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The therapy, however, is not indicated for patients with primary central nervous system lymphoma.
The approval stemmed from early ZUMA-1 trial (NCT02348216) data, which showed high response rates in Yescarta-treated patients. Of the 101 patients treated with a single infusion, 72 percent responded to therapy and 51 percent were in complete remission.
A recent analysis, conducted after a median follow-up of 15.4 months, shows that more than half of patients who responded are still progression-free. Indeed, 42 percent of patients continue to respond to Yescarta, and 40 percent are disease-free.
In this analysis, 12 percent of patients experienced grade 3 or higher cytokine release syndrome (CRS), and 31 percent experienced neurologic toxicities.
“Historically, people with refractory large B-cell lymphoma have not been adequately served by available treatment options,” said David Chang, MD and PhD, worldwide head of research and development and chief medical officer at Kite.
“We are encouraged by the durability and depth of response seen in ZUMA-1 more than a year after treatment with Yescarta, which represents an important advance in the treatment of patients with refractory disease,” he added.
The European Medicines Agency (EMA) is currently reviewing a marketing authorization application (MAA) for Yescarta. If approved, the therapy will be available in Europe in 2018.