Legend Biotech's LB2501 achieves 100% ORR, 83.3% CR in Phase 1 B-NHL study
Legend Biotech announced positive first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). In an ongoing Phase 1 study, LB2501 achieved a 100% objective response rate (ORR) and an 83.3% complete response (CR) rate at the higher dose level (DL2) following a single infusion, with all responses ongoing. The therapy demonstrated dose-dependent CAR-T expansion without lymphodepletion and a favorable safety profile, reporting no dose-limiting toxicities, serious adverse events, ICANS, or deaths. These results were presented at the EHA 2026 Congress, highlighting the company's progress in next-generation cell therapies.
Key Highlights
- LB2501 achieved 100% ORR (6/6) at DL2 in R/R B-NHL patients.
- LB2501 achieved 83.3% CR rate (5/6) at DL2, with all responses ongoing.
- Dose-dependent in vivo CAR-T expansion observed without lymphodepletion.
- No DLTs, SAEs, ICANS, or deaths reported in the Phase 1 study.
- Infusion-related reactions and CRS were Grade 1–2; no glucocorticoids needed.
- CAR-T cells detectable for up to 116 days in peripheral blood.
- Overall ORR was 50.0% (6/12) and CR rate was 41.7% (5/12) across both dose levels.
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