Lyell reports strong ronde-cel response rates in lymphoma trials
Lyell Immunopharma reported updated clinical results for its experimental CAR T-cell therapy ronde-cel in relapsed or refractory large B-cell lymphoma on November 4, 2026. The treatment produced a 91% overall response rate and 77% complete response rate among 44 response-evaluable patients treated in the third-line-or-later PiNACLE trial, while a second-line Phase 1/2 cohort recorded a 95% overall response rate and 76% complete response rate among 37 patients. Lyell said the abstracts will be presented at the American Society of Hematology meeting on December 12-15, 2026, and that it expects full PiNACLE data in mid-2027 and a BLA filing in the second half of 2027.
Why it matters
The results provide additional clinical evidence for Lyell's lead therapy as it advances through pivotal testing, although the product remains investigational. Lyell expects to submit a biologics license application in the second half of 2027, subject to the pivotal trial's progress.
Key facts
- 1In the PiNACLE third-line-or-later cohort, ronde-cel generated a 91% overall response rate and a 77% complete response rate among 44 response-evaluable patients. investing.com
- 2In the second-line Phase 1/2 cohort, ronde-cel generated a 95% overall response rate and a 76% complete response rate among 37 patients. investing.com
- 3The median progression-free survival was not reached in either reported cohort. investing.com
- 4Lyell expects full pivotal PiNACLE results in mid-2027 and a BLA submission in the second half of 2027. stocktitan.net
- 5The U.S. FDA has granted ronde-cel RMAT and Fast Track designations for relapsed or refractory diffuse large B-cell lymphoma in the third-line-or-later setting, plus RMAT designation in the second-line setting. stocktitan.net
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.