Lyell Immunopharma, Inc. · NASDAQ:LYEL
Lyell Immunopharma — American Society of Hematology (ASH) 2025
13 slides from Lyell Immunopharma's conference presentation, Dec 7, 2025
Slide 1: Rondecabtagene Autoleucel Achieves Durable Responses in Large B-Cell Lymphoma
Rondecabtagene Autoleucel, an Autologous, Dual-Targeting CD19/CD20 CAR T-Cell Candidate Manufactured from CD62L+ Enriched T Cells, Achieves Durable Responses in Patients with Large B-Cell Lymphoma Sarah M. Larson1, Umar Farooq2, Tahir Latif3, Felix Mensah4, Bradley D. Hunter5, Stefan O. Ciurea6, Neb
Slide 2: CD19 CAR T-Cell Products Transformed the Treatment of LBCL, But Have Limitations
CD19 CAR T-Cell Products Transformed the Treatment of LBCL, But Have Limitations Despite these advances, next-generation CAR T-cell products with improved safety and efficacy are needed • Limited durability: • Additional limitations: o ~40% of patients in 3L+ LBCL remain in complete o Complete respo
Slide 3: Dual-Targeting CD19/CD20 CAR T Cells Enriched for Stem-Like Phenotype (CD62L+)
Dual-Targeting CD19/CD20 CAR T Cells Enriched for Stem-Like Phenotype (CD62L+) Rondecabtagene autoleucel (ronde-cel) designed to achieve high complete response rates and long duration of responses • Ronde-cel is a true CD19/CD20 "OR" logic-gated CAR Ronde-cel ◦ Designed to target either CD19 and CD2
Slide 4: Ronde-Cel Trial Schematic
Ronde-Cel Trial Schematic Phase 1/2 multi-cohort, multi-center trial in aggressive large B-cell lymphoma (3L+ and 2L cohorts) Ronde-cel Infusion Enrollment/ Single Dose Leukapheresis 100 x 106 CAR T cells Lymphodepletion Optional Flu 30 mg/m2 Post-treatment Response Assessment Bridging Therapy Cy 50
Slide 5: High-Risk, Heavily Pre-Treated, Multi-Center US Patient Population
High-Risk, Heavily Pre-Treated, Multi-Center US Patient Population Baseline characteristics in 3L+ and 2L patients consistent with high risk compared to historical studies Demographics and 3L+ Overall 2L Overall Disease Characteristics N = 45 N = 24 Median (range) age, years 64 (21, 87) 65 (26, 85)
Slide 6: Higher-Risk Demographic and Disease Characteristics in 3L+ HGBCL versus LBCL
Higher-Risk Demographic and Disease Characteristics in 3L+ HGBCL versus LBCL Patients with HGBCL have bulkier disease, higher LDH, more extranodal disease, are older, and have more limited ECOG status Demographics and Disease 3L+ LBCL 3L+ HGBCL 3L+ Overall Characteristics N = 37 N=8 N = 45 Median (r
Slide 7: Overall Response Rate of 93% and Complete Response Rate of 76% (3L+ LBCL)
Overall Response Rate of 93% and Complete Response Rate of 76% (3L+ LBCL) High rate of durable complete responses in LBCL Best Overall Response • Median progression free survival (mPFS) was 18 months N = 29 (3L+ LBCL) ◦ Median duration of follow-up 12 months Overall Responses, n (%) 27 (93%) • 72% (
Slide 8: Durable Responses in Patients with 3L+ LBCL
Durable Responses in Patients with 3L+ LBCL Median progression-free survival of 18 months; 72% of patients with CR remained in CR at ≥ 6 months Data cutoff: November 11, 2025. LBCL includes DLBCL, PMBCL, Grade 3B FL, and tFL. HGBCL not included. CR, complete response. 8
Slide 9: High Overall Response Rate in Patients with 2L Aggressive B-Cell Lymphoma
High Overall Response Rate in Patients with 2L Aggressive B-Cell Lymphoma High-risk characteristics including HGBCL with 94% of patients with primary refractory disease Best Overall Response N = 18 (2L Overall) Overall Responses, n (%) 15 (83%) Complete Responses, n (%) 11 (61%) Partial Response, n
Slide 10: Dexamethasone Prophylaxis Reduced Grade ≥3 ICANS to <5% of Patients
Dexamethasone Prophylaxis Reduced Grade ≥ 3 ICANS to < 5% of Patients Adverse events of interest (3L+ and 2L cohorts) Adverse Event, n (%) Adverse Event, n (%) Prophylaxis All Prophylaxis All N = 25 N = 69 N = 25 N = 69 CRS 13 (52%) 42 (61%) IEC-HS Grade 1 10 (40%) 22 (32%) Grade 1 or 2 1 (4%) 2 (3%
Slide 11: Ronde-Cel Expansion is Robust in Patients with or without Dexamethasone Prophylaxis
Ronde-Cel Expansion is Robust in Patients with or without Dexamethasone Prophylaxis Higher CAR T-cell expansion is associated with better CAR T-cell response CAR T-Cell Expansion with or without Prophylactic Dexamethasone Prophylaxis No Prophylaxis Median ddPCR Copies/g DNA All Patients • No signif
Slide 12: Conclusions
Conclusions Phase 1/2 multi-cohort, multi-center trial evaluating ronde-cel in aggressive B-cell lymphoma (3L+, 2L) • High rate of durable complete responses in high-risk patients in 3L+ LBCL: ◦ Overall response rate of 93% and a complete response rate of 76% ◦ Median progression-free survival of 18
Slide 13: Ronde-Cel is a Promising CAR T-Cell Candidate for Large B-Cell Lymphoma
Ronde-Cel is a Promising CAR T-Cell Candidate for Large B-Cell Lymphoma Two pivotal trials are underway for ronde-cel (PiNACLE – H2H, PiNACLE) • PiNACLE – H2H has been initiated based upon these promising results: ◦ Phase 3 head-to-head CAR T-cell therapy randomized controlled trial of ronde-cel vs
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