Lyell Immunopharma to Present Positive Updated Ronde-Cel Data in More than 80 Patients at ASH 2026 from PiNACLE Pivotal Trial in 3L+ and from Phase 1/2 2L Cohort in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Ronde-cel showed 91% ORR and 77% CR in 44 3L+ LBCL patients in PiNACLE; 95% ORR in 2L cohort, no grade 3+ CRS.
What this release says
Lyell Immunopharma reported updated data for its CAR T-cell therapy ronde-cel in relapsed or refractory large B-cell lymphoma, to be presented at the ASH 2026 meeting in December. Both the single-arm PiNACLE pivotal trial in later-line patients and a Phase 1/2 second-line cohort showed high response rates, with no severe cytokine release syndrome reported. For a shareholder, the data supports the program's progress, but full pivotal results are not expected until mid-2027, with a BLA submission to follow later that year.
Key figures
- Overall response rate, 3L+ pivotal
- 91%
- Complete response rate, 3L+ pivotal
- 77%
- Overall response rate, 2L cohort
- 95%
- Complete response rate, 2L cohort
- 76%
- Patients in 3L+ pivotal trial
- 44 response-evaluable
- Patients in 2L cohort
- 37 response-evaluable
Positive for shareholders
- Complete responses were durable, with 92% of responders remaining in complete response at six months in both cohorts.
- No Grade 3 or higher cytokine release syndrome was seen in either cohort.
- Grade 3 or higher neurotoxicity was reported in 9% of patients, supporting outpatient administration.
Negative for shareholders
- Full pivotal data from PiNACLE are not expected until mid-2027, with BLA submission expected in the second half of 2027.
- The 2L data come from a Phase 1/2 cohort, and the randomized Phase 3 PiNACLE-H2H trial is still ongoing.
- Both cohorts are small, so the results rest on a limited number of patients.
Written by Quantisnow AI from this release. Not financial advice.
Key terms
- Complete response rate:
- The share of treated patients whose cancer disappears completely after therapy.
- Cytokine release syndrome:
- A potentially serious immune reaction that can occur when CAR T-cell therapies activate the immune system.
- BLA:
- Biologics License Application, the filing a company submits to the FDA to seek approval for a biological therapy.
- RMAT:
- Regenerative Medicine Advanced Therapy designation, an FDA program that speeds review of promising cell and gene therapies.
FAQ
What did Lyell Immunopharma report about ronde-cel?
Lyell reported updated data showing a 91% overall response rate and 77% complete response rate in 44 patients in the PiNACLE pivotal trial, and a 95% overall response rate in the 2L cohort.
When does Lyell expect full pivotal data and a BLA submission for ronde-cel?
The release says full pivotal data from PiNACLE are expected in mid-2027, with a BLA submission expected to follow in the second half of 2027.
Will the updated ronde-cel data be presented at a medical meeting?
Yes, two abstracts were accepted for presentation at the 68th ASH Annual Meeting taking place December 12 to 15, 2026, in New Orleans.
Historical context for LYEL
Across the 24 sessions after earlier LYEL headlines, the stock closed higher 12 times and lower 12 times, with a median move of 3.4% in either direction. This shows timing only: many things move a stock in a session, and these figures do not show that any headline caused a move.
| Session | Earlier headline | LYEL | SPY |
|---|---|---|---|
| Nov 2, 2026 | Lyell Immunopharma To Participate in November Investor Events | -1.4% | -0.5% |
| Sep 14, 2026 | Lyell Immunopharma To Participate in the Baird 2026 Global Healthcare Conference | -5.3% | -0.4% |
| Sep 11, 2026 | Lyell Immunopharma Completes Manufacturing Transfer for LYL273 and Provides Updated Timeline on Phase 1/2 Trial in Metastatic Colorectal Cancer | -2.0% | +0.9% |
| Aug 7, 2026 | Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2026 | +3.5% | +0.6% |
| Aug 6, 2026 | Stifel initiated coverage on Lyell Immunopharma with a new price target | +5.7% | -0.2% |
| Jul 22, 2026 | B. Riley Securities initiated coverage on Lyell Immunopharma with a new price target | -2.1% | -0.1% |
- Market cap
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- Industry
- Biotechnology: Pharmaceutical Preparations
- Listed since
- 2021
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