- Updated JULIET trial analysis confirms high, durable overall response rate (ORR) from tisagenlecleucel in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
Why this matters
- Median OS is currently 4.4 months in patients with R/R DLBCL who cannot receive high-dose chemotherapy or autologous stem cell transplant (ASCT).
- Phase 2 JULIET study of tisagenlecleucel in 115 adults with R/R DLBCL (99 main cohort, 16 cohort A) who progressed after ≥2 lines of therapy, including rituximab and an anthracycline.
- Ineligible for/failed ASCT.
- 51% had ≥3 prior lines of chemotherapy.
- 49% received prior ASCT.
- 90% of infusion patients received bridging chemotherapy, 93% received lymphodepletion chemotherapy.
- Funding: Novartis.
- ORR, 54% (95% CI, 43%-64%) at a median follow-up of 19.3 months postinfusion.
- 40% complete response (CR).
- No relapses beyond 11 months postinfusion.
- 54% of partial response patients reached complete response.
- ORR similar across subgroups.
- OS probability at 18 months, 43% (95% CI, 33%-53%).
- No patients in remission proceeded to allogeneic SCT or ASCT.
- Median OS 11.1 months for all infused patients (95% CI, 6.6 months-not evaluable).
- No new safety signals or treatment-related mortality.
- Median duration of response and median OS for CR patients not reached.
- “What we showed specifically was that their quality of life did improve over time, their physical well-being certainly also improved over time, and their ability to actually function and perform activities of everyday living improved over time. We predicted that emotional wellbeing would also improve over time, and we actually found that was relatively stable,” said researcher Richard Maziarz, of Oregon Health & Science University.