Lyell Immunopharma, Inc 8-K, filed Dec 8, 2025
Lyell Immunopharma, Inc. (LYEL)
About this 8-K
Lyell Immunopharma, Inc filed this 8-K on December 8, 2025, reporting on events of December 7, 2025.
Items reported
- Item 8.01: Other events
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| Item 8.01 | Other Events. |
On December 7, 2025, Lyell Immunopharma, Inc. (the “Company”) presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition new clinical and translational data from its ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients with large B-cell lymphoma (“LBCL”). Ronde-cel is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (“CAR”) T-cell product candidate in pivotal development for patients with relapsed and/or refractory (“R/R”) LBCL. Ronde-cel CAR T cells are designed to have enhanced antitumor activity through a proprietary manufacturing process that enriches for CD62L-positive cells to produce a CAR T-cell product with a higher proportion of naïve and central memory T cells.
Sixty-nine CAR T-cell naïve patients with R/R LBCL received ronde-cel as of September 5, 2025 (the data cutoff date for the presentation at ASH). The efficacy evaluable population, defined as those patients with Day 84 assessments or prior disease progression or death, consisted of 47 patients (29 in the third- or later-line (“3L+”) setting and 18 in the second-line (“2L”) setting). Patient demographics and baseline disease characteristics were consistent with a high-risk, heavily pre-treated patient population, particularly as compared to historical trials of CD19 CAR T-cell products: median ages of 64 and 65 years with 20% (9/45) and 21% (5/24) of patients being 75 years or older in the 3L+ and 2L settings, respectively; and primary refractory disease in 49% (22/45) and 92% (22/24) of patients in the 3L+ and 2L settings, respectively.
Patients Evaluated in the 3L+ Setting
There were 29 efficacy-evaluable 3L+ patients with R/R LBCL (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, Grade 3B follicular lymphoma, or transformed follicular lymphoma) with a median follow up time of 12 months as of the data cutoff date. In these patients:
| • | The overall response rate was 93% (27/29 patients), with 76% (22/29) of patients achieving a complete response |
| • | 72% (13/18) of patients with complete response remained in complete response at 6 months or longer |
| • | Median progression-free survival was 18 months |
Patients Evaluated in the 2L Setting
There were 18 efficacy-evaluable patients enrolled in the 2L setting with a median follow-up time of 9 months as of the data cutoff date. Of these efficacy-evaluable patients, 94% had primary refractory disease. In these patients:
| • | The overall response rate was 83% (15/18 patients), with 61% (11/18) achieving a complete response |
| • | 70% (7/10) of patients with complete response remained in complete response at ≥ 6 months |
| • | The median duration of complete response was not reached |
Safety Data
In 69 patients, including patients from both the 3L+ and the 2L cohorts, a manageable safety profile appropriate for outpatient administration was observed. No Grade 3 or greater cytokine release syndrome (“CRS”) was observed. Twenty-five of the 69 patients received protocol-directed dexamethasone prophylaxis (10 mg/day for 3 days). One case (4%) of Grade 3 or greater immune effector cell-associated neurotoxicity syndrome (“ICANS”) was reported in a patient with high disease burden; no case of Grade 2 ICANS was reported.
In all 69 patients, as of the data cutoff date, low rates of Grade 1 (32%) or Grade 2 (29%) CRS were reported; ICANS rates were reported as follows: Grade 1 (9%), Grade 2 (3%), and Grade 3 or greater (12%) of patients. The median time to complete resolution of all reports of ICANS was 4 days. Cell pharmacodynamic data demonstrated robust CAR T-cell expansion and persistence that were similar in patients with or without dexamethasone prophylaxis. No deaths were determined to be related to ronde-cel administration.
Ronde-cel Translational Data
Translational data from the ongoing Phase 1/2 clinical trial showed that ronde-cel manufactured with CD62L enrichment achieved robust expansion and high expression of memory-related genes after infusion in patients with LBCL. An evaluation of ronde-cel and published data for CD19 CAR T-cell products demonstrated that ronde-cel had a higher proportion of CD62L-positive T cells with a higher proportion of memory-cell phenotype prior to infusion (ronde-cel, N = 34; axi-cel, N = 110 and tisagenlecleucel (tisa-cel), N = 31). In addition, ronde-cel had up to a three-fold higher expansion in patients after infusion compared to the expansion of approved CD19 CAR T-cell products. The product memory-cell phenotype was positively correlated with expansion. Peripheral blood samples collected from patients one month after infusion (N = 9) also had a higher proportion of CAR T cells with a memory phenotype compared to cells from axi-cel-treated patients (N = 4). Ronde-cel CAR-positive T cells collected from patients one (N = 7) and two months (N = 3) after infusion demonstrated sustained capacity to proliferate, kill tumor cells over 72 hours, and secrete cytokines (N = 3).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Lyell Immunopharma, Inc. | ||||||
| Date: December 8, 2025 | By: | /s/ Mark Meltz | ||||
| Mark Meltz | ||||||
| General Counsel | ||||||