Lyell Immunopharma to Present Phase 1/2 Safety and Translational Data for Ronde-Cel in Large B-Cell Lymphoma at the European Hematology Association 2026 Congress

Lyell Immunopharma (Nasdaq: LYEL) will present Phase 1/2 ronde-cel data in relapsed or refractory large B-cell lymphoma at the EHA 2026 Congress in Stockholm, June 11–14, 2026.

Rhea-AI Summary

Lyell Immunopharma (Nasdaq: LYEL) will present Phase 1/2 ronde-cel data in relapsed or refractory large B-cell lymphoma at the EHA 2026 Congress in Stockholm, June 11–14, 2026.

Two posters will cover updated safety (CRS, ICANS) and translational findings on durable responses and T-cell memory. Ronde-cel is also in two pivotal PiNACLE trials, with updated 3L+ data expected 2H 2026 and pivotal data by mid-2027, supporting a planned 2027 BLA submission.

Argus Jun 5 session

-8.28% close to close Open Argus

Details

News Market Reaction – LYEL

In the Jun 5 session, LYEL declined 8.28%, reflecting a notable negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -8.3% in the session following this news. The decline reflects a sharp divergence fr...

Analysis

The stock moved -8.3% in the session following this news. The decline reflects a sharp divergence from prior clinical updates, which on average moved the stock about 2.3%, with several positive reactions. A -15.58% move against largely developmental, non-outcome EHA poster news suggests sentiment or positioning rather than a clear data readout. An effective S-3 resale shelf for 1,952,360 shares and the stock trading well below its 200-day MA could also frame perceptions of overhang and risk.

Key Figures

Phase 1/2 trial: Phase 1/2 EHA 2026 dates: June 11–14, 2026 Poster time: 12:45 pm EDT / 6:45 pm CEST +5 more

Phase 1/2 trial

Phase 1/2

Ongoing ronde‑cel trial in R/R LBCL referenced for EHA 2026 posters

EHA 2026 dates

June 11–14, 2026

European Hematology Association 2026 Congress timing in Stockholm

Poster time

12:45 pm EDT / 6:45 pm CEST

Scheduled time for both ronde‑cel poster presentations on June 12

Pivotal trials count

2 pivotal trials

Ronde‑cel being evaluated in two pivotal LBCL clinical trials

Third-line setting

3L+

PiNACLE single‑arm pivotal ronde‑cel trial in 3L+ R/R LBCL

Second-line setting

2L

PiNACLE‑H2H Phase 3 trial comparing ronde‑cel to axi‑cel or liso‑cel

Pivotal data timing

Mid-2027

PiNACLE pivotal ronde‑cel data expected timeline in 3L+ setting

Planned BLA year

2027

Expected Biologics License Application submission for ronde‑cel

Previous Clinical trial Reports

5 past events · Latest: Feb 12

Same Type 5 events

1. Feb 12

   Phase 3 dosing start

   24h Move

   +4.3%

   First patient dosed in Phase 3 PiNACLE‑H2H head‑to‑head ronde‑cel trial.

2. Dec 07

   ASH data update

   24h Move

   +12.3%

   New ASH data showed high ORR, CR rates and durable responses in LBCL.

3. Nov 03

   ASH oral data

   24h Move

   -0.7%

   Announcement of two oral ASH talks highlighting high responses and safety.

4. Sep 03

   Phase 3 initiation

   24h Move

   +0.2%

   Initiation of Phase 3 head‑to‑head CAR T trial and steering committee formation.

5. Jun 17

   Phase 1/2 data

   24h Move

   -4.6%

   Positive Phase 1/2 LYL314 data with high ORR/CR and durable responses.

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

Key Terms

chimeric antigen receptor (car) t-cell therapies, large b-cell lymphoma, car t-cell, icans, +3 more

7 terms

chimeric antigen receptor (car) t-cell therapies medical

"advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients"

Chimeric antigen receptor (CAR) T-cell therapies are treatments that take a patient’s own immune cells, reprogram them to recognize a specific marker on diseased cells, and return them to the body to seek and destroy those targets. Think of it as retraining the body’s soldiers with new GPS coordinates so they can find hidden threats. Investors care because these therapies can be highly effective for certain illnesses, command premium prices, and carry significant development, manufacturing and regulatory risks that affect company valuations.

large b-cell lymphoma medical

"rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma"

Large B‑cell lymphoma is a type of fast-growing cancer that starts in B cells, a kind of white blood cell that helps the body fight infection. For investors it matters because the condition drives demand for diagnostics, treatments and clinical trials; positive or negative trial results, regulatory decisions or new therapies can quickly change a biotech or drug maker’s revenue prospects, similar to how a breakthrough product can reshape a company’s future.

car t-cell medical

"dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma"

CAR T-cell therapy uses a patient’s own immune cells that have been removed, reprogrammed in a lab to recognize a specific marker on cancer cells, and returned to the body to seek and destroy tumors. Think of it as giving a person's white blood cells a custom-made 'GPS' that guides them to cancer cells. Investors watch CAR T-cell programs because they can command high prices, involve complex manufacturing and regulatory risk, and their clinical success or failure can sharply affect a biotech company's value.

icans medical

"Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell"

ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) is a range of brain-related side effects that can occur after certain immune-cell cancer therapies, such as CAR-T. Symptoms can include confusion, speech problems, seizures or reduced consciousness, and they are caused by an overactive immune response affecting the brain. Investors care because ICANS can influence patient safety, trial outcomes, regulatory approvals, treatment labeling and adoption, all of which affect a therapy’s commercial prospects and development costs.

phase 3 randomized medical

"In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against"

A phase 3 randomized trial is a late-stage clinical study in which a large group of people are randomly assigned to receive either the experimental treatment or a comparison (such as a placebo or existing therapy) to measure how well the treatment works and how safe it is. Investors watch these trials closely because their outcomes largely determine whether a drug can win regulatory approval and reach broad sales, similar to a final road test before a product hits the market.

biologics license application (bla) regulatory

"pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in 2027"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

dual-targeting cd19/cd20 medical

"Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR T-Cells) are Associated"

A dual-targeting CD19/CD20 therapy is a cancer treatment designed to recognize and attack cells that carry either or both of the CD19 and CD20 markers, proteins commonly found on certain blood cancer cells. For investors, it matters because the two-pronged approach can lower the chance of the cancer evading therapy and broaden the number of patients who may respond, affecting potential clinical success, market size, and competitive positioning.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SOUTH SAN FRANCISCO, Calif., June 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that the Company will present data from its ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) at the European Hematology Association (EHA) 2026 Congress, taking place in Stockholm, Sweden, June 11–14, 2026. The data will be featured in two poster presentations covering an updated ronde-cel safety analysis and translational insights.

EHA 2026 Poster Presentations

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis

• Poster: PF962
• Session: Large B-Cell Lymphomas – Clinical; Hall A
• Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
• Presenting Author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA

Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products

• Poster: PF1097
• Session: Lymphoma Biology & Translational Research; Hall A
• Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
• Presenting Author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center

Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

The posters will be available through the Science section of the Company's website at www.lyell.com after the presentations.

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 1,200 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: Lyell's planned presentations at a medical congress; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; and the sufficiency of the capacity of LyFE to manufacture drug supply through potential commercial launch. 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 described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 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.

Contact:

Pablo Fenton
Associate Director, Investor Relations and Corporate Communications
pfenton@lyell.com 

FAQ

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

What is Lyell Immunopharma (LYEL) presenting at the EHA 2026 Congress?

Lyell Immunopharma is presenting Phase 1/2 data for ronde-cel in relapsed or refractory large B-cell lymphoma at EHA 2026. According to Lyell, two posters will detail updated safety results and translational insights on response durability and T-cell memory characteristics.

When and where will Lyell (LYEL) ronde-cel posters be presented at EHA 2026?

The ronde-cel posters are scheduled for Friday, June 12, 2026, at 12:45 pm EDT / 6:45 pm CEST in Hall A. According to Lyell, both safety and translational research posters will appear under clinical and lymphoma biology sessions at the Stockholm EHA 2026 Congress.

What safety data on CRS and ICANS for ronde-cel will Lyell (LYEL) share at EHA 2026?

Lyell plans to present an updated safety analysis titled “Low-Grade CRS and ICANS with Rondecabtagene Autoleucel” in large B-cell lymphoma. According to Lyell, this Phase 1/2 poster will describe cytokine release syndrome and neurotoxicity outcomes for patients receiving the dual-targeting CD19/CD20 CAR T-cell product candidate.

What translational findings for ronde-cel are being reported by Lyell (LYEL) at EHA 2026?

Lyell is presenting data linking durable responses to a higher proportion of cytotoxic T cells with memory potential in ronde-cel infusion products. According to Lyell, this poster highlights how dual-targeting CD19/CD20 CAR T-cell composition may relate to sustained clinical responses in large B-cell lymphoma.

What are the pivotal PiNACLE trials of ronde-cel that support Lyell (LYEL) plans?

Ronde-cel is in a single-arm PiNACLE trial for 3L+ large B-cell lymphoma and a Phase 3 PiNACLE-H2H head-to-head study in 2L. According to Lyell, 3L+ updated data are expected 2H 2026, with pivotal data by mid-2027 and a BLA submission planned in 2027.

Which comparators are used in Lyell (LYEL) PiNACLE-H2H Phase 3 trial for ronde-cel?

The PiNACLE-H2H trial evaluates ronde-cel in second-line large B-cell lymphoma against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel. According to Lyell, this randomized Phase 3 design compares its dual-targeting CD19/CD20 CAR T-cell candidate with two established CAR T therapies.