Ronde-cel Demonstrates Strong Efficacy With Manageable Safety Profile Across LBCL Treatment Lines

Lyell Immunopharma (LYEL) unveiled compelling efficacy and safety data for its dual-targeting CAR T candidate at the American Society of Hematology meeting in December 2025, marking a significant milestone for the company’s immunotherapy pipeline.

Superior Response Rates Across Treatment Settings

The clinical data from the Phase 1/2 trial examined Ronde-cel’s (LYL314) performance in two distinct patient populations. In the third-line or later-line (3L+) setting, the dual CD19/CD20-targeting therapy achieved a 93% overall response rate among 29 efficacy-evaluable patients, with 76% achieving complete remission. The median progression-free survival extended to 18 months, and notably, 72% of those with complete responses maintained their remission status for at least six months.

In second-line (2L) treatment, Ronde-cel showed sustained efficacy across 18 evaluable patients, generating an 83% response rate with 61% achieving complete response. A particularly encouraging finding was that 70% of complete responders maintained their response durability beyond six months, while the median duration of complete response remained unreached at the data cutoff.

Switch to Manageable Safety Architecture

A critical differentiator for Ronde-cel lies in its favorable safety profile. The trial observed zero instances of Grade 3 or higher cytokine release syndrome (CRS), addressing a major safety concern with earlier CAR T therapies. Immune effector cell-associated neurotoxicity syndrome (ICANS) incidence remained low, and the company noted that prophylactic dexamethasone administration further reduced neurological complications, providing a manageable safety framework for broader patient populations.

Pipeline Advancement and Market Position

Two pivotal trials are progressing to validate these initial findings. PiNACLE, a single-arm trial expanding from the Phase 1/2 3L+ cohort, will assess durability in relapsed or refractory large B-cell lymphoma patients. Meanwhile, PiNACLE-H2H represents a Phase 3 head-to-head comparison between Ronde-cel and established CD19 CAR T therapies in the 2L setting, positioning the candidate as a potential treatment option switch for patients.

With $320 million in cash reserves as of September 2025, Lyell maintains sufficient capital runway into 2027 to navigate key clinical inflection points. Market sentiment reflected the data release, with LYEL stock rising 4.55% in overnight trading following the Friday close at $25.25, though it has ranged between $7.56 and $25.74 over the trailing twelve months.