- A single infusion of KTE-X19, a novel chimeric antigen receptor (CAR) T-cell therapy, yields durable response in patients with relapsed or refractory mantle cell lymphoma after failure of Bruton's tyrosine kinase inhibitor therapy.
- The treatment is associated with a higher rate of serious toxicities.
Why this matters
- Patients with recurrent/relapsed disease have poor prognosis and warrant novel therapeutic options.
- Multicenter phase 2 ZUMA-2 trial evaluated 74 patients with relapsed or refractory mantle cell lymphoma who received KTE-X19.
- Funding: Kite, a Gilead company.
- Primary efficacy analysis of 60 patients treated and followed up for 7 months.
- The objective response rate was 93% (complete response, 67%).
- The median follow-up was 12.3 months.
- Overall population:
- 75% of patients achieved objective response and 59% had complete response.
- At data cutoff, 57% of patients with complete response were in remission.
- At 12 months:
- PFS was 61%.
- OS was 83%.
- The grade ≥3 adverse event rate was 99%.
- Most common were cytopenias (94%) and infections (32%).
- Nonfatal cytokine release syndrome and neurologic events occurred in 15% and 31% of patients.
- 68% of patients experienced serious toxicities.
- Single-group study.