Table 3.
Authors and study type | Patient population | Clinical efficacy | Response durations |
---|---|---|---|
Abramson JS et al. JCO 2018 phase 1 TRANSCEND NHL 001 trial |
91 patients received lisocabtagene maraleucel (JCAR017) (81 evaluable for efficacy) | ORR: 74% in FULL dataset, 80% in CORE dataset CR: 52% in FULL, 55% in CORE CORE dataset, dose-level 2: ORR 50%, CR 50% CORE dataset, dose-level 1: ORR 40%, CR 30% |
Not reported |
Locke FL et al. Lancet Oncol 2019 Single-arm, phase I/II ZUMA-1 trial |
101 assessable patients received axicabtagene ciloleucel: 30 DEL 7 HGBL (1 THL, 4 DHL, 2 HGBL NOS) |
All patients: Objective Response: 83% CR: 58% PR: 25% SD: 10% PD: 5% DEL/HGBL patients: Objective Response: 91% CR: 70% |
All patients: Median time to response: 1 month Median duration of response: 11.1 months Median duration of response if CR: Not Reached Median PFS: 5.9 months (95% CI: 3.3–15.0) 24-month PFS: 72.0% if CR at 3 months, 75.0% if PR at 3 months, 22.2% if SD at 3 months |
Schuster SJ et al. NEJM 2019 Single-group phase II JULIET trial |
93 patients with relapsed/refractory DLBCL received tisagenlecleucel | ORR: 52% (95% CI: 41–62) CR: 40% PR: 12% |
12-month RFS: 65% (79% among patients with CR) |
CI, confidence interval; CR, complete response; DHL, double hit lymphoma; DLBCL, diffuse large B-cell lymphoma; HGBL NOS, high-grade B-cell lymphoma not otherwise specified; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; RFS, relapse-free survival; SD, stable disease; THL, triple hit lymphoma.