JULIET 5-year follow-up results: Tisagenlecleucel for R/R LBCL

Results from the 5-year follow-up analysis of the phase II, single-arm, open-label, multicenter, global JULIET trial (NCT02445248), investigating tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of 115 adults with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who have received ≥2 prior lines of therapy (LoT), were published in the Journal of Clinical Oncology by Maziarz et al. The primary endpoint was overall response rate (ORR) per independent review committee (IRC).

Key data: With a median follow-up of 74.3 months, the ORR was 53.0%, with a complete response (CR) rate of 39.1%. The median duration of response (DoR) was not reached; the 60-month event-free probability was 60.5% (95% confidence interval [CI], 46.3–72.0%) among responders (n = 61). The median overall survival (OS) was 11.1 months (95% CI, 6.6–23.9), while responders with a CR/partial response (PR) had a median OS of 76.5 months (95% CI, 37.8–not estimable [NE]). Among patients alive and in follow-up ≥5 years after infusion (n = 30), 80% remained disease-free without receiving additional therapy. No new safety signals or secondary T-cell malignancies were reported.

Key learning: At long-term follow-up, tisagenlecleucel demonstrated durable efficacy in heavily pretreated patients with R/R LBCL, with no new safety signals or secondary T-cell malignancies reported. Results continue to support tisagenlecleucel as a potentially curative therapy in this setting.