Lyell Immunopharma initiates patient dosing in PiNACLE-H2H Phase 3 trial

Lyell Immunopharma (LYEL) announced that the first patient has been dosed in the PiNACLE – H2H Phase 3 trial evaluating rondecabtagene autoleucel compared to lisocabtagene maraleucel or axicabtagene ciloleucel for the treatment of patients with relapsed or refractory large B-cell lymphoma receiving treatment in the second-line setting. “Data from Lyell’s single-arm pivotal PiNACLE trial in patients with later-stage large B-cell lymphoma are expected to be submitted for marketing approval to the FDA next year,” said David Shook, MD, Lyell’s Chief Medical Officer. “We are now pleased to have underway PiNACLE – H2H, the first-of-its-kind Phase 3 head-to-head randomized controlled CAR T-cell trial. This strategy demonstrates Lyell’s confidence in ronde-cel’s potential to be the best-in-class CAR T-cell treatment for patients with relapsed or refractory disease.”