Lyell Immunopharma (LYEL) investor relations material

Oncology program updates

• Dual targeting CD19/CD20 CAR T cell program for large B-cell lymphoma is in pivotal trials, with a major data update expected in the second half of the year and pivotal data anticipated mid-next year, followed by a BLA submission before year-end 2027.

• A head-to-head trial of Ronde-cel versus Yescarta or Breyanzi is actively recruiting, aiming to provide direct comparative data in the second-line setting.

• LYL273, a GCC-targeted CAR for metastatic colorectal cancer, is progressing in phase I with significant safety improvements after implementing a new GI prophylaxis regimen.

Clinical trial data and expectations

• Ronde-cel showed a 93% overall response rate, 76% complete response rate, and 18-month median PFS in third-line LBCL, outperforming existing CD19 CARs.

• Updated pivotal trial data will include more patients and longer follow-up, with expectations for sustained or improved durability.

• The head-to-head phase III trial randomizes 200 patients per arm, stratified for key risk factors, with event-free survival as the primary endpoint and an interim analysis planned.

• LYL273 phase I data show GI toxicity reduced from 55% to 10% post-prophylaxis, with no Grade 3 CRS or ICANS observed.

Market opportunity and competitive landscape

• Third-line plus LBCL market estimated at 6,000–7,000 patients, supported by retrospective and Medicare claims data.

• Ronde-cel aims to replace current CD19 CARs by offering superior efficacy and safety, with a strong lead in trial recruitment and design reflecting current clinical practice.

• Competitors are developing in vivo and autologous dual-targeting CARs, but Ronde-cel’s durability and cell selection are seen as differentiators.

• CD20 bispecifics and allogeneic approaches are being explored, but autologous CAR T remains favored for its one-time, durable benefit.