Axi-cel CAR-T extends EFS as second-line therapy for advanced large B-cell lymphoma
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Patients with relapsed or refractory large B-cell lymphoma who received second-line axicabtagene ciloleucel achieved significantly longer EFS than those who received standard of care, according to data released by the agent’s manufacturer.
Axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead Sciences) — also known as axi-cel — is an autologous, gene-edited chimeric antigen receptor T-cell therapy that targets CD19 on the surface of cancer cells.
The FDA previously approved the agent for use by adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma who received two or more lines of systemic therapy.
The randomized phase 3 ZUMA-7 trial assessed axi-cel vs. standard of care second-line therapy for patients with large B-cell lymphoma.
The study included 359 patients (age range, 22-81 years; 30% aged 65 years or older) randomly assigned to a single infusion of axi-cel or standard-of-care therapies for relapsed or refractory disease, which included either chemotherapy or a combination of chemotherapy followed by hematopoietic stem cell transplant.
EFS served as the primary endpoint. Overall response rate served as a secondary endpoint.
Median follow-up for the study was 2 years.
Results showed a significant EFS improvement (HR = 0.39; P < .0001) among patients assigned axi-cel.
Researchers also reported a trend toward improved OS among axi-cel treated patients; however, OS data were immature and will be updated in a future analysis, according to a Kite-issued press release.
Axi-cel exhibited a safety profile consistent with that observed with use of the agent in the third-line setting.
Six percent of patients developed grade 3 or higher cytokine release syndrome, with median onset of 3 days. Twenty-one percent of patients developed grade 3 or higher neurotoxicity.
“The top-line results of the randomized ZUMA-7 trial paint the picture of a potential paradigm shift in the treatment of large B-cell lymphoma,” Frederick L. Locke, MD, ZUMA-7 lead principal investigator, co-leader of the immuno-oncology program at Moffitt Cancer Center and member of the Cell Therapy Next Peer Perspective Board, said in the release. “The outcomes for patients relapsing after frontline chemotherapy in this study are dramatically improved with rapid referral [to a CAR-T center] and a single infusion of axicabtagene ciloleucel as compared [with] chemotherapy and consolidative autologous transplant, the longstanding second-line standard of care.”
More detailed results from ZUMA-7 will be presented at a medical conference, according to the release. Kite officials also plan to submit a supplemental biologics license application later to the FDA later this year in hopes of obtaining approval of axi-cel as second-line therapy for large B-cell lymphoma.
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