Schuster SJ, et al. - Researchers performed this international study of chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel in adults with relapsed or refractory diffuse large B-cell lymphoma. Findings revealed high rates of durable responses with the use of tisagenlecleucel.

Methods

• This was an international, phase 2, pivotal study of centrally manufactured tisagenlecleucel.
• Participants were adult patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation.
• The best overall response rate was the primary end point (ie, the percentage of patients who had a complete or partial response), as judged by an independent review committee.

Results

• Efficacy analyses included 93 patients who received an infusion.
• According to data, the median time from infusion to data cutoff was 14 months (range, 0.1 to 26).
• They noted best overall response rate was 52% (95% confidence interval, 41 to 62); complete responses and partial responses were seen in 40% of the patients and in 12%, respectively.
• Across prognostic subgroups, consistent response rates were observed.
• They reported a 65% rate of relapse-free survival (79% among patients with a complete response) at 12 months after the initial response.
• Cytokine release syndrome (22%), neurologic events (12%), cytopenias lasting more than 28 days (32%), infections (20%), and febrile neutropenia (14%) were documented as the most common grade 3 or 4 adverse events of special interest.
• Within 30 days after infusion, death of 3 patients due to disease progression was reported.
• Tisagenlecleucel, cytokine release syndrome, or cerebral edema were not responsible for any of the deaths reported.
• With regard to tumor expression of CD19 or immune checkpoint–related proteins, no differences were seen between response groups.