Legend Biotech's LB2501 Shows 100% Response in Early Lymphoma Trial

Legend Biotech has released the first clinical proof-of-concept data for its experimental therapy LB2501. The treatment is being tested in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Early results show promising outcomes in an ongoing Phase 1 study. LB2501 is an in vivo CD19CD20 dual-targeting CAR-T cell therapy designed to treat B-cell malignancies. It is currently under evaluation in a Phase 1 study (NCT07002112) to assess its safety, tolerability, and preliminary effectiveness in patients with relapsed or refractory disease.

The study reported no dose-limiting toxicities, serious adverse events, or deaths. The most common side effects were infusion-related reactions and cytokine release syndrome, all of which were mild to moderate (Grade 1-2).

At the higher dose level (DL2), LB2501 achieved a 100% objective response rate and an 83.3% complete response rate in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. All responses at this dose were ongoing at the time of data cutoff, with effectiveness observed across various lymphoma subtypes, including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma.

Pharmacokinetic analyses revealed dose-dependent CAR-T cell expansion in all patients at DL2 and in 83% at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Vector integrations were highly polyclonal and diverse, supporting the proof-of-concept for in vivo T-cell engineering with LB2501. The early data demonstrate a favourable safety profile and strong preliminary efficacy for LB2501. The therapy’s ability to induce durable responses without lymphodepletion marks a significant development in CAR-T cell treatment for B-cell malignancies. Further evaluation in the ongoing study will provide additional insights.