Lyell Immunopharma to Present Positive Updated Ronde-Cel Data in More than 80 Patients at ASH 2026 from PiNACLE Pivotal Trial in 3L+ and from Phase 1/2 2L Cohort in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Key Highlights
- ➤3L+ PiNACLE: 91% overall response, 77% complete response in 44 patients
- ➤2L Phase 1/2: 95% overall response, 76% complete response in 37 patients
- ➤3L+ median PFS not reached; estimated 24-month PFS was 54%
- ➤2L median PFS not reached; estimated 12-month PFS was 55%
- ➤No Grade ≥ 3 CRS occurred in either cohort of treated patients
Expert Statements
Jarrad Aguirre, M.D., Chief Medical Officer of Lyell
“We believe the high complete response rates and durability of remissions observed with ronde-cel in both the second-line and third- or later-line settings, including in patients with high-risk disease, are impressive. The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling and reinforces our confidence in ronde-cel’s ability to meaningfully improve patient outcomes. We look forward to presenting updated results at ASH, including additional patients and longer follow-up, as we advance ronde-cel toward potential registration.”
* Ronde-cel achieved a 91% overall response rate and 77% complete response rate; median progression-free survival not reached and estimated 6-month duration of complete response of 92% in 44 patients with 3L+ R/R LBCL in the PiNACLE pivotal trial * Ronde-cel achieved a 95% overall response rate and 76% complete response rate; median progression-free survival not reached and estimated 6-month duration of complete response of 92% in 37 patients with 2L R/R LBCL in the Phase 1/2 trial * No Grade ≥ 3 cytokine release syndrome was observed in either cohort and Grade ≥ 3 neurotoxicity was reported in < 10% of patients supporting outpatient administration SOUTH SAN FRANCISCO, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that two abstracts featuring positive updated clinical data for rondecabtagene autoleucel (ronde-cel) have been accepted for presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 12–15, 2026, in New Orleans (ASH 2026).
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