Lyell ronde-cel Phase 1/2 data shows strong safety, 97% manufacturing success
Lyell Immunopharma announced new safety and translational data for its CAR T-cell therapy, ronde-cel, from an ongoing Phase 1/2 clinical trial in patients with relapsed or refractory large B-cell lymphoma (LBCL). The data, presented at EHA 2026, showed no Grade ">= 3" Cytokine Release Syndrome (CRS) and low rates of Grade ">= 3" Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) across over 100 patients, supporting outpatient administration. Manufacturing success rate was 97%. Translational data supported the biological basis for durable responses, highlighting CD62L+ enrichment and CD19/CD20 dual-targeting. The company expects PiNACLE pivotal trial data updates in H2 2026, pivotal data readout in mid-2027, and BLA submission in H2 2027.
Key Highlights
- Over 100 patients treated with ronde-cel in 2L and 3L+ LBCL.
- Ronde-cel manufacturing success rate of 97%.
- No Grade ">=" 3 Cytokine Release Syndrome (CRS) reported.
- Low rates of Grade ">=" 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (8% with prophylaxis, 16% without).
- Translational data supports durable responses via CD62L+ enrichment and CD19/CD20 dual-targeting.
- PiNACLE pivotal trial data update expected in H2 2026.
- Pivotal data readout expected in mid-2027, with BLA submission in H2 2027.
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