Lyell Immunopharma (NASDAQ: LYEL) has announced the initiation of PiNNACLE—H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the 2L setting. The company also announced the formation of the PiNNACLE—H2H Steering Committee of renowned lymphoma experts.
Lyell is now advancing two pivotal trials for patients with R/R LBCL. In addition to PiNNACLE—H2H, PiNACLE is a single-arm pivotal trial of ronde-cel that is enrolling patients with R/R LBCL receiving treatment in the third- or later-line (3L+) setting.
In a statement, Michael Jain, MD, PhD, PiNACLE—H2H Steering Committee member and Immune Cell Therapy Medical Director in the Moffitt Cancer Center Department of Blood and Marrow Transplant and Cellular Immunotherapy, commented, “Lyell is undertaking a well-designed and innovative Phase 3 trial to provide patients and their physicians with the data needed to demonstrate the potential clinical benefit of ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy, over and above that of the currently approved CD19 CAR T-cell therapies. I am encouraged by the promising data from the Phase 1/2 clinical trial of ronde-cel and believe this innovative cell therapy can improve clinical outcomes for patients.”
Matthew Lunning, DO, PiNACLE—H2H Steering Committee member and Professor in the Division of Hematology/Oncology at the University of Nebraska Medical Center, remarked, “Lyell is leading the field with the announcement of the first Phase 3 head-to-head CAR T-cell therapy trial for patients with large B-cell lymphoma. We have designed this trial evaluating ronde-cel to include the spectrum of patients who are currently receiving CD19 CAR T-cell therapy in the large B-cell lymphoma setting, as well as to provide the option for treatment in the outpatient setting based on the safety profile observed to date.”
