Kite, a Gilead Company, and Arcellx are preparing to launch a Phase III clinical trial, named iMMagine-3, to assess the efficacy and safety of anitocabtagene autoleucel (anito-cel) in patients with relapsed and/or refractory multiple myeloma (RRMM). This randomized, controlled, global study will compare anito-cel against the standard of care in RRMM patients who have received one to three prior lines of therapy. The trial is expected to begin in the second half of 2024.
The iMMagine-3 trial aims to enroll approximately 450 adult participants across 130 study sites in North America, Europe, and other regions. Anito-cel is a B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy, representing a novel approach to targeting multiple myeloma cells.
The primary endpoint of the trial is progression-free survival. Secondary endpoints include complete response rate, overall survival, minimal residual disease negativity, and safety. These measures will provide a comprehensive assessment of anito-cel's clinical benefit and risk profile.
Cindy Perettie, Executive Vice-President at Kite, emphasized the unmet need in RRMM and the importance of manufacturing quality, reliability, and speed for patients. "We are pleased to start the Phase III pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma," she stated. "As we prepare for this pivotal programme, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy."
Manufacturing and Collaboration
Kite's facility in Frederick, Maryland, will be responsible for producing anito-cel for the iMMagine-3 trial. This follows a technical transfer from a third-party contract manufacturer and the transfer of the US Food and Drug Administration cleared Investigational New Drug application, marking a significant milestone in the therapy's development.
The strategic collaboration between Arcellx and Kite includes joint development and commercialization of anito-cel in the US, with Kite managing marketing internationally. This partnership leverages the strengths of both companies to advance anito-cel through clinical development and towards potential regulatory approval.
Context of BCMA-Targeted Therapies in Multiple Myeloma
Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow. Relapsed and refractory disease remains a significant challenge, with limited treatment options available for patients who have exhausted standard therapies. BCMA has emerged as an important target for immunotherapy in multiple myeloma, with several CAR-T cell therapies and antibody-drug conjugates targeting this antigen already approved or in late-stage development. The iMMagine-3 trial will help determine the role of anito-cel in this evolving treatment landscape.
