Gilead’s Kite announces new data for iMMagine-1 Study at ASH 2025

Kite, a Gilead Company (GILD), and its partner Arcellx (ACLX) announced new positive data from its pivotal iMMagine-1 Phase 2 study of anitocabtagene autoleucel, an investigational agent, which continues to show clinically meaningful deep and durable efficacy with predictable and manageable safety observed to date in relapsed or refractory multiple myeloma, RRMM, patients who had received at least three prior lines of therapy. These new findings from the ongoing study will be shared in an oral presentation during the 67th American Society of Hematology, ASH, Annual Meeting and Exposition. Data from an October 7, 2025 cutoff date, including 117 patients treated with anito-cel, who were followed for a median of 15.9 months, showed an independent review committee-assessed overall response rate of 96%, with 74% achieving a stringent complete response or complete response per International Myeloma Working Group criteria. 102 of 117 patients were triple refractory, 48 of 117 patients were penta refractory, 21 of 117 patients had extramedullary disease, and 47 of 117 patients had high risk cytogenetics. For many in this heavily pre-treated population, responses began quickly, often within one month. Median time to best response was 4.8 months and median time to sCR or CR was 3.2 months. Of the 96 patients evaluable for minimal residual disease testing, 91 achieved MRD negativity at a median time of 1 month, meaning no cancer cells could be detected even with highly sensitive tests.