Lyell Immunopharma (LYEL) investor relations material

Ronde-cel pivotal data and timeline

• In the third-or-later-line PiNACLE trial, ronde-cel showed a 91% overall response rate (ORR), 77% complete response rate (CR), and median PFS not reached; median PFS was 18 months last year and is now expected to be at least 24 months.

• Historical third-or-later-line YESCARTA and BREYANZI results: ORR 72% and 73%, CR 51% and 54%, and median PFS 6–7 months.

• Ronde-cel’s CR durability was 92% at 6 months and 75% at 12 months; PFS rate was 75% at 6 months.

• PiNACLE had 44 efficacy-evaluable patients in the ASH abstract; the presentation was expected to include ~60 patients, with trial enrollment targeting ~100. Final pivotal data and BLA submission were planned for 2027.

Second-line evidence and trial execution

• An updated second-line phase I/II cohort of 43 patients showed 95% ORR, 76% CR, and median PFS not reached; 84% had primary refractory disease.

• In PILOT’s primary-refractory subgroup, BREYANZI’s CR rate was 42%; ronde-cel’s second-line cohort showed 76% CR.

• A randomized head-to-head trial compares ronde-cel with investigator’s choice of YESCARTA or BREYANZI; its primary endpoint is event-free survival. Most of 60 commercially selected centers were active and enrolling.

• The trial update was expected to cover additional second-line data and qualitative enrollment momentum; high-grade B-cell lymphoma patients continue to enroll in the randomized trial.

Product design, safety and manufacturing

• Ronde-cel is a single tandem CAR targeting CD19 and CD20, intended to address low or absent CD19 and reduce antigen escape; CD62L selection enriches the product for naive or central-memory T cells.

• Blended ICANS incidence was 9%, including patients with and without dexamethasone prophylaxis; BREYANZI’s cited ICANS benchmark was 10%.

• Commercial manufacturing was underway at LyFE Manufacturing Center, with capacity for more than 3,000 cell doses, described as sufficient well into launch.