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Single infusion of anti-CD19 CAR T-cells confers high response rate in aggressive non-Hodgkin lymphoma
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The ZUMA-1 trial designed to evaluate axicabtagene ciloleucel in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma met its primary endpoint of overall response rate, according to the drug’s manufacturer.
The ORR was 82% after a single infusion of axicabtagene ciloleucel (KTE-C19, Kite Pharma), an anti-CD19 engineered chimeric antigen receptor (CAR) T-cell product.
“We know as clinicians that patients with aggressive lymphoma who do not respond to their previous treatments have a very poor prognosis. In fact, we know from the SCHOLAR-1 study, these patients have only an 8% chance of achieving a complete response with current therapies,” co-lead investigator Frederick L. Locke, MD, director of research for the immune cell therapy program at Moffitt Cancer Center, said in a press release. “Several patients we treated at Moffitt Cancer Center experienced a rapid and durable complete response with this first-of-its kind therapy. The ZUMA-1 study results suggest that axicabtagene ciloleucel could become a new standard of care for patients with refractory aggressive lymphoma.”
The ZUMA-1 trial evaluated axicabtagene ciloleucel in two cohorts of patients, including 77 patients with diffuse large B-cell lymphoma and 24 patients with mediastinal B-cell lymphoma and transformed follicular lymphoma, for a median follow-up of 8.7 months.
At an interim analysis at month 6, the combined cohorts demonstrated a 41% ORR, with 36% of patients demonstrating a complete response. ORR increased to 82% and complete response rate increased to 54% at the time of the current primary analysis.
Five patients continued to experience durable partial responses with minimal abnormalities in PET scans, including one patient who converted to a complete response at month 9.
Median OS has not yet been reached.
The most common serious adverse events included anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%) and decreased lymphocyte count (20%).
As previously reported, there were three deaths not due to disease progression. One case of hemophagocytic lymphohistiocytosis and one cardiac arrest in the setting of cytokine release syndrome were deemed related to study drug. The third case, a pulmonary embolism, was deemed unrelated. There have been no additional deaths since the interim analysis.
“These results with axicabtagene ciloleucel are exceptional and suggest that more than a third of patients with refractory aggressive non-Hodgkin lymphoma could potentially be cured after a single infusion of axicabtagene ciloleucel,” Jeff Wiezorek, MD, senior vice president of clinical development at Kite Pharma, said in the release.
Based on the combined data, Kite Pharma intends to complete its biologics license application to the FDA this year, the release said.
Full data from the primary analysis will be presented at the American Association for Cancer Research Annual Meeting in April in Washington, D.C.