Lyell Immunopharma disclosed that its dual‑targeting CD19/CD20 CAR‑T product, ronde‑cel (LYL314), achieved a 93% overall response rate (ORR) and a 76% complete response (CR) rate in patients with relapsed or refractory large B‑cell lymphoma (LBCL) who had received three or more prior lines of therapy. The data, presented at the 67th American Society of Hematology meeting, were derived from 47 efficacy‑evaluable patients—29 in the 3L+ cohort and 18 in the 2L cohort. Median progression‑free survival (PFS) in the 3L+ group was 18 months, and 70% of complete responders in the 2L cohort maintained response at six months or longer. No grade 3 or higher cytokine release syndrome (CRS) events were reported, and only one case of grade 3 or higher immune‑effector cell‑associated neurotoxicity syndrome (ICANS) occurred, underscoring a favorable safety profile.
The high efficacy and low toxicity are attributed to ronde‑cel’s dual‑targeting design and a proprietary manufacturing process that enriches for CD62L‑positive memory T cells, which are thought to enhance persistence and durability of the product. The combination of strong clinical activity and manageable safety supports the company’s regulatory strategy, as ronde‑cel has already received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration for the 3L+ indication. The data also suggest the potential for outpatient administration, which could broaden the therapy’s commercial reach and reduce treatment costs.
Lyell plans to advance ronde‑cel into pivotal trials, including the single‑arm PiNACLE study and the head‑to‑head PiNACLE‑H2H trial that will compare the product directly with existing CD19‑only CAR‑T therapies. The company’s LyFE Manufacturing Center is positioned to produce over 1,200 doses at full capacity, and a cash balance of roughly $320 million provides a runway to support these milestones through 2027. The strong clinical results reinforce Lyell’s next‑generation CAR‑T platform and strengthen its competitive positioning in a crowded field.
Dr. David Shook, Lyell’s Chief Medical Officer, said, “The data presented today confirm that targeting both CD19 and CD20 can deliver differentiated benefit for patients with relapsed or refractory large B‑cell lymphoma. The safety profile we observed is encouraging and supports our strategy to move ronde‑cel into pivotal trials.”
Investors reacted positively to the data, reflecting confidence in the therapy’s potential to transform treatment for patients with relapsed or refractory large B‑cell lymphoma and to position Lyell as a leader in next‑generation CAR‑T technology.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.