LYEL•Lyell Immunopharma said ronde-cel achieved a 77% complete response rate in a pivotal lymphoma trial. The company will present updated results at the American Society of Hematology meeting from December 12-15, 2026.
Previously disclosed results showed high complete response rates and durable remissions in patients with relapsed or refractory large B-cell lymphoma treated in the second line and later lines. No severe cytokine release syndrome occurred in either cohort, and severe neurotoxicity was uncommon. The pivotal PiNACLE trial is intended to support an initial application for regular marketing approval; a separate randomized Phase 3 trial compares ronde-cel with approved CD19-directed CAR T-cell therapies in second-line treatment.
