Lyell(US:LYEL) Globenewswire·2025-12-07 21:30Core Insights - Lyell Immunopharma, Inc. announced new clinical data for its CAR T-cell therapy, ronde-cel, showing promising efficacy in treating large B-cell lymphoma (LBCL) with a 93% overall response rate and a 76% complete response rate in the 3L+ setting [1][5][12] - Ronde-cel has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating its potential as a significant treatment option for patients with relapsed and/or refractory LBCL [2][17] Clinical Data Summary - In the 3L+ setting, 29 patients showed a 93% overall response rate and a 76% complete response rate, with a median progression-free survival of 18 months [4][5] - In the 2L setting, 18 patients, predominantly with primary refractory disease, achieved an 83% overall response rate and a 61% complete response rate [6][12] - Safety profile was manageable, with no high-grade cytokine release syndrome (CRS) and low rates of Grade 1 (32%) and Grade 2 (29%) CRS reported [7][6] Pivotal Trials - Lyell has initiated two pivotal trials: PiNACLE – H2H, a head-to-head trial comparing ronde-cel to other CAR T-cell therapies, and PiNACLE, a single-arm trial for the 3L+ setting [8][10] - The PiNACLE – H2H trial aims to enroll approximately 400 patients and focuses on event-free survival as the primary endpoint [9] Translational Data - Ronde-cel demonstrated robust expansion and high expression of memory-related genes post-infusion, with a higher proportion of CD62L-positive T cells compared to other CAR T-cell products [11] - The product showed up to a three-fold higher expansion in patients after infusion compared to approved CD19 CAR T-cell products [11] Company Overview - Lyell Immunopharma is focused on advancing next-generation CAR T-cell therapies for hematologic malignancies and solid tumors, utilizing proprietary manufacturing processes to enhance T-cell efficacy [18][16]