Legend Biotech’s LB2501 Shows 100% ORR and 83.3% CR in Phase 1 B-NHL Trial
LEGN•In a Phase 1 study of LB2501 in relapsed/refractory B-cell non-Hodgkin lymphoma, a single infusion at the higher dose achieved a 100% objective response rate and 83.3% complete response rate with all responses ongoing. The investigational in vivo CAR-T therapy showed dose-dependent expansion without lymphodepletion and no serious or dose-limiting toxicities.
1. Phase 1 Proof-of-Concept Results
In the ongoing Phase 1 trial of LB2501, 12 relapsed/refractory B-NHL patients received single infusions across two dose levels without lymphodepletion. At the higher DL2, ORR was 100% (6/6) and CR rate was 83.3% (5/6), with all responses ongoing at data cutoff.
2. Safety and Tolerability Profile
LB2501 exhibited no dose-limiting toxicities, serious adverse events, neurotoxicity or deaths. Infusion-related reactions occurred in 75% of patients and cytokine release syndrome in 66.7%, all Grade 1–2, none requiring glucocorticoids and four patients received tocilizumab.
3. In Vivo Expansion and Translational Findings
Pharmacokinetic analyses showed dose-dependent CAR-T expansion in 100% of DL2 patients and 83% of DL1 patients, with cells detectable up to 116 days. Rapid vector clearance to undetectable levels within 24 hours and highly polyclonal integration patterns confirmed in vivo T-cell engineering specificity.
