Arcellx to Present Clinical Data on Multiple Myeloma Studies at 66th ASH Meeting and Updates on iMMagine-3

Arcellx, Inc., a biotechnology firm based in Redwood City, California, has announced its upcoming presentations at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, scheduled for December 7-10, 2024, in San Diego. The company is set to share multiple studies on anitocabtagene autoleucel (anito-cel) for treating patients with relapsed or refractory multiple myeloma (RRMM).

The Phase 2 iMMagine-1 trial (abstract #1031) includes 58 patients who have received an anito-cel infusion and have been followed for a median of 10.3 months. The median age of these patients is 66 years, with most having received four prior treatments. A significant portion of the patients were also triple-class and penta-class refractory. The overall response rate (ORR) was 95%, with a complete or stringent complete response rate of 62%. Notably, 92% achieved minimal residual disease negativity. The study reported a 6-month progression-free survival (PFS) rate of 90% and an overall survival (OS) rate of 95%. Importantly, there have been no delayed neurotoxicities observed, and cytokine release syndrome (CRS) was manageable, with no grade 3 or 4 cases. The most common severe adverse events included neutropenia, thrombocytopenia, and anemia.

The Phase 1 study (abstract #4825) included 40 patients, with 38 receiving anito-cel. An impressive 100% ORR was noted, with 79% achieving a complete response. Among those evaluated for minimal residual disease, 89% were negative. With a median follow-up of 38.1 months, the median PFS was 30.2 months, and the median OS has not yet been reached. The safety profile was manageable, with no delayed neurotoxicities observed.

Additionally, Arcellx will present findings from a systematic literature review and meta-analysis (abstract #4721) focusing on health-related quality of life (HRQoL) in RRMM patients. This study highlighted significant impairments in global health status, cognitive, physical, and emotional functioning among these patients. The quality of life worsened with increasing lines of therapy.

Furthermore, a publication in "Blood" will detail treatment patterns and outcomes in triple-class exposed patients with RRMM (abstract #6962). This study, based on data from the Flatiron Health electronic health record, found no clear standard of care for patients in the fourth line of treatment and reported suboptimal health outcomes, emphasizing the need for more effective therapies.

Arcellx will host a live webcast on December 9, 2024, to discuss these findings further, accessible via their website.

Multiple myeloma (MM) is a type of cancer affecting plasma cells in the bone marrow, leading to bone damage and impaired immune function. It is the third most common hematological malignancy in the US and Europe. Anitocabtagene autoleucel is Arcellx’s innovative BCMA-directed CAR T-cell therapy granted several designations by the FDA for its potential in treating MM.

The iMMagine-3 trial is a global Phase 3 study comparing the efficacy of anito-cel with standard care in RRMM patients. This trial aims to enroll approximately 450 patients and will assess progression-free survival as the primary endpoint, among other secondary endpoints, across various sites worldwide.

Arcellx has collaborated with Kite, a Gilead Company, to co-develop and commercialize anito-cel. This partnership aims to advance the development and accessibility of this promising therapeutic approach for patients with RRMM.

Arcellx, Inc. remains committed to advancing cell therapies to create safer, more effective options for patients with cancer and other incurable diseases.