Lyell Immunopharma Inc. (NASDAQ:LYEL) gained 4.2% in premarket trading Monday after the company released encouraging new data from its cancer therapy programs.
The biotech reported that its CAR T-cell candidate, rondecabtagene autoleucel (ronde-cel), achieved a 93% overall response rate and a 76% complete response rate in patients with large B-cell lymphoma treated in the third-line or later setting. Median progression-free survival reached 18 months.
In the second-line setting—where 94% of patients had difficult-to-treat primary refractory disease—ronde-cel delivered an 83% overall response rate and a 61% complete response rate. Lyell noted that safety findings support use in the outpatient setting.
Ronde-cel is engineered through a proprietary manufacturing process that enriches the product with a higher proportion of naïve and central memory T cells, aiming to boost antitumor activity. The FDA has already granted the therapy Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B-cell lymphoma.
Two pivotal studies are underway:
- PiNACLE – H2H, a Phase 3 head-to-head trial comparing ronde-cel with standard-of-care CAR T therapies in second-line treatment.
- PiNACLE, a single-arm pivotal trial for patients receiving therapy in the third-line or later setting.
Translational data from these studies showed that ronde-cel exhibits strong in vivo expansion and elevated expression of memory-associated genes, reaching up to three-fold higher expansion than currently approved CD19 CAR T products.
The findings were presented at the 67th American Society of Hematology Annual Meeting and Exposition.