Lyell Immunopharma Announces Initiation of Patient Dosing in First-of-Its-Kind Phase 3 Head-To-Head CAR T-Cell Clinical Trial in Aggressive Large B-Cell Lymphoma

Core Insights - Lyell Immunopharma, Inc. has initiated the first patient dosing in the PiNACLE – H2H Phase 3 trial, evaluating its CAR T-cell therapy, rondecabtagene autoleucel (ronde-cel), against other approved therapies for relapsed or refractory large B-cell lymphoma [1][2] Group 1: Trial Details - The PiNACLE – H2H trial is a Phase 3 head-to-head randomized controlled trial comparing ronde-cel to either lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory large B-cell lymphoma [2][6] - Approximately 400 patients will be enrolled, with 200 patients per arm, and the primary endpoint is event-free survival [2][6] - Ronde-cel will be administered at a dose of 100 x 10 CAR T cells, and patients may receive treatment in either inpatient or outpatient settings [2][4] Group 2: Clinical Data and Efficacy - In previous trials, ronde-cel demonstrated a best overall response rate of 93% and a complete response rate of 76% in patients with relapsed or refractory large B-cell lymphoma [5] - The median progression-free survival was reported as 18 months for patients in the 3L+ cohort [5] - In the 2L cohort, an 83% best overall response rate and a 61% complete response rate were observed among patients, with a significant portion having high-risk primary refractory disease [5] Group 3: Product Information - Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell product designed to enhance complete response rates compared to existing therapies [8][10] - The product has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for treatment in both the 2L and 3L+ settings [10] - Ronde-cel is manufactured to produce CAR T-cells with higher proportions of naïve and central memory T cells, aimed at improving antitumor activity [9]