Kite submits supplemental BLA for Yescarta in advanced follicular, marginal zone lymphoma
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Kite Pharma has submitted a supplemental biologics license application to the FDA for axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma, according to the agent’s manufacturer.
The application covers use of the anti-CD19 autologous chimeric antigen receptor T-cell therapy after two or more previous lines of systemic therapy.
Axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead) has been approved by the FDA for adults with relapsed or refractory large B-cell lymphoma after two or more lines of therapy.
The agent also received the FDA’s breakthrough therapy designation.
The application is supported by data from the ongoing ZUMA-5 trial. The primary analysis of the trial’s phase 2 data will be presented at an upcoming major medical meeting, according to the manufacturer.
An interim analysis of the trial, presented during this year’s ASCO20 Virtual Scientific Program, showed axicabtagene ciloleucel produced durable responses in a cohort of patients with indolent non-Hodgkin lymphoma — which includes follicular lymphoma and marginal zone lymphoma.
The efficacy analysis showed patients with follicular lymphoma had an objective response rate of 95%, with a complete response rate of 81%. Patients with marginal zone lymphoma had an ORR of 81% and a complete response rate of 75%. Median duration of response was 20.8 months for all patients in the study.
“People living with indolent non-Hodgkin lymphoma often experience a disease that starts out slowly but becomes more aggressive over time with each subsequent relapse,” Ken Takeshita, MD, global head of clinical development for Kite Pharma, said in a press release.
“The efficacy observed in ZUMA-5 may provide a potentially transformative treatment option for higher-risk patients with certain types of indolent non-Hodgkin lymphoma,” he added. “We look forward to working closely with the FDA to progress this application with the goal of bringing Yescarta to patients with indolent non-Hodgkin lymphoma as soon as possible.”
If approved by the FDA, axicabtagene ciloleucel would become the first commercially available CAR T-cell therapy for either follicular or marginal zone lymphoma, according to the manufacturer.
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