Arcellx and Kite Advance Anito-Cel Multiple Myeloma Program

Arcellx, Inc. and Kite, a Gilead Company, have made significant strides in their collaborative effort to develop anitocabtagene autoleucel (anito-cel) for treating multiple myeloma. Anito-cel, an innovative BCMA CAR T-cell therapy, incorporates Arcellx's unique D-Domain binder, distinguishing it in the treatment of this condition. The companies recently outlined the structure of their global Phase 3 clinical trial, iMMagine-3, which aims to commence in the latter half of this year. This trial will evaluate the efficacy and safety of anito-cel in comparison to the standard of care (SOC) for patients with relapsed and/or refractory multiple myeloma (rrMM), who have undergone one to three previous lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.

The production of anito-cel for iMMagine-3 will take place at Kite’s facility in Frederick, Maryland, following a successful technical transfer from a third-party manufacturer. This facility's readiness underscores the advancements made towards initiating the trial, which has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application.

Rami Elghandour, Arcellx’s Chairman and CEO, highlighted the trial's aim to assess anito-cel as a second to fourth line treatment for multiple myeloma patients previously treated with both an immunomodulatory drug and an anti-CD38 monoclonal antibody. This approach aligns with the evolving treatment paradigm, where anti-CD38 therapies are moving to frontline treatment, thereby addressing a significant unmet clinical need.

Cindy Perettie, Kite’s Executive Vice President, expressed satisfaction with the progress towards starting the iMMagine-3 trial, acknowledging the substantial unmet needs among relapsed and/or refractory multiple myeloma patients. She emphasized Kite's commitment to leveraging its manufacturing expertise to position anito-cel as a potential leading cell therapy, stressing the importance of manufacturing quality, reliability, and speed given the critical nature of timely treatment for patients.

The iMMagine-3 trial, a randomized controlled study, will enroll approximately 450 adult patients. Participants will be assigned to either the anito-cel arm or the SOC arm, with SOC regimens comprising various combinations of drugs like pomalidomide, bortezomib, dexamethasone, daratumumab, and carfilzomib. Patients in the anito-cel group will undergo leukapheresis and may receive optional bridging therapy, followed by lymphodepleting chemotherapy and a single infusion of anito-cel.

The primary endpoint of the trial is progression-free survival (PFS), evaluated by an independent review based on the 2016 IMWG criteria for multiple myeloma. Secondary endpoints include complete response rate, minimal residual disease negativity, overall survival, and safety metrics. The trial is set to launch in the latter half of 2024 across approximately 130 sites globally.

Arcellx and Kite’s collaboration extends beyond this trial, encompassing the joint development and commercialization of anito-cel in the United States, with Kite handling commercialization outside the U.S. Anito-cel has also secured Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations from the FDA, reflecting its potential significance in treating multiple myeloma.

Arcellx continues to innovate in the field of cell therapy, with additional programs targeting other forms of cancer and incurable diseases. The company's mission is to advance cell therapies that are safer, more effective, and accessible, marking significant progress in the fight against cancer.