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

Complete responses persisted at six months in 92% of responders in both treatment cohorts.

Rhea-AI Summary

Lyell Immunopharma (LYEL) reported updated ronde-cel results showing a 91% overall response rate in evaluable patients receiving third- or later-line treatment. In the pivotal PiNACLE trial, 44 patients evaluable at Day 84 had a 77% complete response rate. A Phase 1/2 second-line cohort of 37 evaluable patients had 95% overall and 76% complete response rates. Both cohorts involved relapsed or refractory large B-cell lymphoma, cancer that returned or resisted treatment.

Median progression-free survival was not reached in either cohort; median follow-up was 12 and nine months, respectively. No grade 3 or higher cytokine release syndrome occurred, while grade 3 or higher neurological toxicity occurred in 9% of treated patients in each cohort. Lyell expects updated presentations at ASH, December 12–15, 2026, full PiNACLE pivotal data in mid-2027 and a marketing application in the second half of 2027.

11 points · 0 major

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPiNACLE third- or later-line responses reached 91% overall and 77% complete among 44 Day 84-evaluable patients.
• Moderate pointSecond-line Phase 1/2 responses reached 95% overall and 76% complete among 37 Day 84-evaluable patients.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Lyell expects full PiNACLE data in mid-2027, followed by a marketing application in the second half of 2027.
• Minor pointPiNACLE complete responses persisted in 92% at six months and 75% at 12 months; median duration remained unreached.
• Minor pointSecond-line complete responses persisted in 92% at six months and 67% at 12 months; median duration remained unreached.

6 minor points

• Minor pointPiNACLE estimated progression-free survival was 76%, 63% and 54% at six, 12 and 24 months, respectively.
• Minor pointSecond-line estimated progression-free survival was 75% at six months and 55% at 12 months.
• Minor pointMedian progression-free survival remained unreached, with median follow-up of 12 months in PiNACLE and nine months second-line.
• Minor pointGrade 3 or higher cytokine release syndrome was absent in all 58 PiNACLE and 43 second-line treated patients.
• Minor pointRonde-cel holds FDA RMAT and Fast Track designations for third- or later-line disease and RMAT designation second-line.
• Minor pointPiNACLE-H2H is ongoing, comparing ronde-cel with an approved CD19-directed cell therapy in a randomized Phase 3 second-line trial.

Negative

• Moderate pointGrade 3 or higher immune-cell-associated neurological toxicity occurred in 9% of treated patients in each cohort.
• Minor pointPiNACLE cytokine release syndrome, an immune reaction, occurred at grade 1 in 48% and grade 2 in 22%.
• Minor pointSecond-line cytokine release syndrome occurred at grade 1 in 49% and grade 2 in 19%.

News Explained

The added durability detail is that 92% of complete responders in each cohort remained in complete response at six months; at 12 months, the reported rates were 75% for the third-or-later-line cohort and 67% for the second-line cohort.

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Key Figures

Overall response rate: 91% (40/44) Complete response rate: 77% (34/44) Complete response at 6 months: 92% +5 more

Overall response rate

91% (40/44)

3L+ R/R LBCL; response-evaluable at Day 84

Complete response rate

77% (34/44)

3L+ R/R LBCL; response-evaluable at Day 84

Complete response at 6 months

92%

3L+ patients who achieved a complete response

Grade ≥ 3 ICANS

9%

3L+ R/R LBCL cohort

Overall response rate

95% (35/37)

2L R/R LBCL; response-evaluable at Day 84

Complete response rate

76% (28/37)

2L R/R LBCL; response-evaluable at Day 84

Complete response at 6 months

92%

2L patients who achieved a complete response

Grade ≥ 3 ICANS

9%

2L R/R LBCL cohort

Previous Clinical trial Reports

2 past events · Latest: Feb 12

Same Type 2 events

1. Feb 12

   Ronde-cel clinical data

   24h Move

   +4.3%

   Reported 3L+ response results and initiated a randomized Phase 3 second-line trial.

2. Dec 07

   Ronde-cel clinical data

   24h Move

   +12.3%

   Reported 3L+ and 2L response findings, including complete response rates.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

progression-free survival, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, autologous

4 terms

progression-free survival medical

"median progression-free survival (PFS) was not reached"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

cytokine release syndrome medical

"No Grade ≥ 3 cytokine release syndrome (CRS) was observed"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

immune effector cell-associated neurotoxicity syndrome medical

"Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS)"

immune effector cell-associated neurotoxicity syndrome (ICANS) is a brain-related side effect that can occur after treatments that activate powerful immune cells, such as engineered cell therapies. It can cause confusion, speech problems, seizures or coma when the immune response unintentionally harms brain function; think of an overenthusiastic security system that starts damaging the house it’s protecting. Investors care because ICANS affects clinical trial results, regulatory approvals, product labeling, treatment adoption, monitoring costs and potential liability, all of which influence a therapy’s commercial value.

autologous medical

"rondecabtagene autoleucel (ronde-cel) is a next-generation, dual-targeting"

Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.

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• Ronde-cel achieved a 91% overall response rate and 77% complete response rate; median progression-free survival not reached and estimated 6-month duration of complete response of 92% in 44 patients with 3L+ R/R LBCL in the PiNACLE pivotal trial
• Ronde-cel achieved a 95% overall response rate and 76% complete response rate; median progression-free survival not reached and estimated 6-month duration of complete response of 92% in 37 patients with 2L R/R LBCL in the Phase 1/2 trial
• No Grade ≥ 3 cytokine release syndrome was observed in either cohort and Grade ≥ 3 neurotoxicity was reported in < 10% of patients supporting outpatient administration
  
  

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that two abstracts featuring positive updated clinical data for rondecabtagene autoleucel (ronde-cel) have been accepted for presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 12–15, 2026, in New Orleans (ASH 2026).

The abstracts highlight results in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting in an oral presentation, and in the second-line (2L) setting in a poster presentation. Ronde-cel is a dual-targeting CD19/CD20 autologous CAR T-cell product candidate currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the 2L setting. Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.

“We believe the high complete response rates and durability of remissions observed with ronde-cel in both the second-line and third- or later-line settings, including in patients with high-risk disease, are impressive,” said Jarrad Aguirre, M.D., Chief Medical Officer of Lyell. “The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling and reinforces our confidence in ronde-cel’s ability to meaningfully improve patient outcomes. We look forward to presenting updated results at ASH, including additional patients and longer follow-up, as we advance ronde-cel toward potential registration.”

Third- or Later-Line (3L+) LBCL Oral Abstract and Clinical Highlights

Overall, 58 patients received ronde-cel as of the June 18, 2026 data cutoff date. The median age was 64 years, approximately 50% of treated patients had primary refractory disease, and 64% were refractory to their last therapy. Of 44 patients response-evaluable at Day 84, the overall response rate was 91% (40/44) and the complete response rate was 77% (34/44). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 75% at 12 months. The median progression-free survival (PFS) was not reached, with estimated PFS rates of 76%, 63% and 54% at six, 12 and 24 months, respectively; median PFS follow-up was 12 months.

No Grade ≥ 3 cytokine release syndrome (CRS) was observed among all treated patients (N = 58). Grade 1 CRS occurred in 48% of patients and Grade 2 in 22% of patients. Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9% of patients.

Updated results, including additional patients and longer follow-up, are expected to be presented at ASH 2026.

Second-Line (2L) LBCL Poster Abstract and Clinical Highlights

In the fully enrolled Phase 1/2 second-line cohort, 43 patients received ronde-cel, including 86% (37/43) with primary refractory disease. Among 37 patients response-evaluable at Day 84, the overall response rate was 95% (35/37) and complete response rate was 76% (28/37). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 67% at 12 months. Median PFS was not reached, with estimated PFS rates of 75% at six months and 55% at 12 months; median PFS follow-up was nine months.

No Grade ≥ 3 CRS was observed among all treated patients (N = 43). Grade 1 CRS occurred in 49% of patients and Grade 2 in 19% of patients. Grade ≥ 3 ICANS occurred in 9% of patients.

Updated results, including longer follow-up, are expected to be presented at ASH 2026. Ronde-cel is also being evaluated in PiNACLE-H2H, an ongoing randomized Phase 3 trial in the 2L setting.

Abstract Details:

Oral Abstract 1028: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with 3L+ relapsed/refractory large B-cell lymphoma: results from the ongoing pivotal PiNACLE trial

Presenting author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA

Session: Monday, December 14, 2026, 4:45 CST

Poster Abstract 2402: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with predominantly primary refractory, second-line relapsed/refractory large B-cell lymphoma

Presenting author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center

Session: Saturday, December 12, 2026, 5:30 CST

About Ronde-Cel

Rondecabtagene autoleucel (ronde-cel) is a next-generation, dual-targeting CD19/CD20 autologous CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response compared to approved CD19-targeted CAR T-cell therapies for R/R LBCL. Ronde-cel targets B cells expressing either CD19 or CD20 and is manufactured using a process that enriches for CD62L-positive cells designed to generate more naïve and central memory CAR T cells to improve the durability of responses by promoting in vivo persistence and the antitumor activity of CAR T cells.

Ronde-cel is being evaluated in two pivotal trials in R/R LBCL: PiNACLE is a multi-center single-arm pivotal trial in the 3L+ setting. Full pivotal data from this trial are expected in mid-2027 with BLA submission expected to follow in the second half of 2027. PiNACLE-H2H is a Phase 3 randomized controlled head-to-head CAR T-cell trial in the 2L setting. Patients with R/R LBCL following one prior line of therapy are randomized to receive ronde-cel or investigator’s choice of one of two approved CD19 CAR T-cell therapies. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in the 3L+ setting and RMAT designation in the 2L setting.

About Lyell Immunopharma, Inc.

Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. LyFE has commercial launch capability and is expected to have the capacity to manufacture more than 3,000 CAR T-cell doses per year. To learn more, please visit www.lyell.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential clinical benefits and therapeutic potential of ronde-cel; Lyell’s expectations around the progress of the PiNACLE and PiNACLE-H2H trials, including the expected timing for release of additional data at ASH 2026, regulatory actions and the anticipated benefits of regulatory designations; the capability of LyFE to manufacture ronde-cel through potential commercial launch and its expected manufacturing capacity; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: Lyell operates in a rapidly evolving industry and has a limited operating history; Lyell’s ability to successfully develop, manufacture and commercialize product candidates or its experiencing significant delays in doing so; Lyell’s dependence on the enrollment and retention of patients in its current and planned clinical trials for its product candidates; the potential for results of Lyell’s research, nonclinical studies or earlier clinical trials to not be predictive of future results; clinical development involving a lengthy and expensive process with uncertain outcomes; Lyell’s product candidates and technologies being based on novel technologies that are unproven and may not result in approvable or marketable products; Lyell facing substantial competition in a rapidly changing industry, which may result in others discovering, developing or commercializing products before or more successfully than it does; Lyell’s ability to obtain and maintain sufficient intellectual property protection for its product candidates; the complexity of manufacturing cellular therapies; Lyell’s ability to manufacture drug products for its clinical trials itself and any potential delays in further qualifying or in receiving regulatory approvals for any manufacturing facility or product candidates or in expanding its manufacturing capacity; Lyell’s reliance on third parties; implementation of Lyell’s strategic plans for its business and product candidates and Lyell’s realization of the expected benefits of such plans; the potential reduction of Lyell’s cash resources and fluctuations in Lyell’s operating results and financial condition as a result of Lyell’s milestone, royalty and success payment obligations; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange Commission on August 6, 2026. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.

Lyell Investor Relations

IR@lyell.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What response rates did Lyell's ronde-cel achieve in large B-cell lymphoma?

Ronde-cel achieved 91% overall and 77% complete response rates in 44 Day 84-evaluable third- or later-line PiNACLE patients. In the Phase 1/2 second-line cohort, 37 Day 84-evaluable patients had 95% overall and 76% complete response rates.

When does Lyell expect to submit ronde-cel for marketing approval?

Lyell expects a marketing application in the second half of 2027, following full PiNACLE pivotal data expected in mid-2027. The single-arm PiNACLE trial is intended to support an initial application for regular marketing approval in the third- or later-line setting.

How many patients received ronde-cel in Lyell's reported cohorts, and how many had refractory disease?

58 patients received ronde-cel in PiNACLE as of June 18, 2026, and 43 received it in the fully enrolled Phase 1/2 second-line cohort. Approximately 50% of PiNACLE patients had primary refractory disease, and 64% were refractory to their last therapy. In the second-line cohort, 86% (37/43) had primary refractory disease.