Ronde-cel achieves 91% response rate in pivotal large B-cell lymphoma trial ahead of ASH 2026 – Lyell
Lyell Immunopharma will present updated data for rondecabtagene autoleucel (ronde-cel), its investigational dual-targeting CD19/CD20 CAR T-cell therapy, in relapsed or refractory large B-cell lymphoma (LBCL). The data will be presented at the 68th American Society of Hematology (ASH) Annual Meeting, which runs from 12 to 15 December 2026.
Third-line and later: the pivotal PiNACLE trial
As of the 18 June 2026 data cutoff, 58 patients had received ronde-cel. Their median age was 64. Around half had primary refractory disease, and 64% were refractory to their last therapy.
Among 44 patients evaluable at day 84, the overall response rate was 91% and the complete response rate was 77%. Of the patients with a complete response, 92% were still in complete response at six months and 75% at 12 months. Median progression-free survival (PFS) was not reached. Estimated PFS was 76% at six months, 63% at 12 months and 54% at 24 months, with a median follow-up of 12 months. These data will be presented orally.
Second-line: Phase 1/2 cohort
In the fully enrolled second-line cohort, 43 patients received ronde-cel, and 86% of them had primary refractory disease. Among 37 evaluable patients, the overall response rate was 95% and the complete response rate was 76%. Complete responses were maintained in 92% of patients at six months and 67% at 12 months. Estimated PFS was 75% at six months and 55% at 12 months, with a median follow-up of nine months.
Safety
Neither cohort had any grade ≥3 cytokine release syndrome. Grade ≥3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9% of patients in each cohort. Lyell says this profile supports giving the therapy in an outpatient setting.
“The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling,” said Jarrad Aguirre, MD, Lyell’s chief medical officer.
Next steps
Full pivotal data from PiNACLE are expected in mid-2027, with a Biologics License Application (BLA) to follow in the second half of that year. Ronde-cel is also being compared head-to-head with approved CD19 CAR T-cell therapies in the second-line Phase 3 PiNACLE-H2H trial. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in the third-line and later setting, and RMAT designation in the second-line setting.
Ronde-cel targets B cells that express either CD19 or CD20. Its manufacturing process enriches for CD62L-positive cells, to generate CAR T cells designed to persist longer in the body.
Lyell Immunopharma will present updated data for rondecabtagene autoleucel (ronde-cel), its investigational dual-targeting CD19/CD20 CAR T-cell therapy, in relapsed or refractory large B-cell lymphoma (LBCL). The data will be presented at the 68th American Society of Hematology (ASH) Annual Meeting, which runs from 12 to 15 December 2026.
Third-line and later: the pivotal PiNACLE trial
As of the 18 June 2026 data cutoff, 58 patients had received ronde-cel. Their median age was 64. Around half had primary refractory disease, and 64% were refractory to their last therapy.
Among 44 patients evaluable at day 84, the overall response rate was 91% and the complete response rate was 77%. Of the patients with a complete response, 92% were still in complete response at six months and 75% at 12 months. Median progression-free survival (PFS) was not reached. Estimated PFS was 76% at six months, 63% at 12 months and 54% at 24 months, with a median follow-up of 12 months. These data will be presented orally.
Second-line: Phase 1/2 cohort
In the fully enrolled second-line cohort, 43 patients received ronde-cel, and 86% of them had primary refractory disease. Among 37 evaluable patients, the overall response rate was 95% and the complete response rate was 76%. Complete responses were maintained in 92% of patients at six months and 67% at 12 months. Estimated PFS was 75% at six months and 55% at 12 months, with a median follow-up of nine months.
Safety
Neither cohort had any grade ≥3 cytokine release syndrome. Grade ≥3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9% of patients in each cohort. Lyell says this profile supports giving the therapy in an outpatient setting.
“The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling,” said Jarrad Aguirre, MD, Lyell’s chief medical officer.
Next steps
Full pivotal data from PiNACLE are expected in mid-2027, with a Biologics License Application (BLA) to follow in the second half of that year. Ronde-cel is also being compared head-to-head with approved CD19 CAR T-cell therapies in the second-line Phase 3 PiNACLE-H2H trial. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in the third-line and later setting, and RMAT designation in the second-line setting.
Ronde-cel targets B cells that express either CD19 or CD20. Its manufacturing process enriches for CD62L-positive cells, to generate CAR T cells designed to persist longer in the body.
Updated data from more than 80 patients, across both the third-line and second-line settings, will be presented in New Orleans.
