Kite Announces New Data for Pivotal iMMagine-1 Study at ASH 2025, Highlighting Anito-cel’s Opportunity in Relapsed or Refractory Multiple Myeloma

Kite, a Gilead Company (Nasdaq: GILD), and its partner Arcellx, today announced new positive data from its pivotal iMMagine-1 Phase 2 study of anitocabtagene autoleucel (anito-cel), 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 (Abstract #256) today at 2:45 PM ET during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

“These data are compelling and are an important advancement for patients living with multiple myeloma,” said Dr. Krina Patel, lead investigator, Associate Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “I am encouraged by the depth of responses in the iMMagine-1 study. For clinicians, we rely on therapies that deliver continued meaningful efficacy, a predictable safety profile, and reliable manufacturing. Anito-cel demonstrates that it could become a significant new treatment option in our efforts to improve outcomes for patients with multiple myeloma.”

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 (IRC)-assessed overall response rate (ORR) of 96%, with 74% achieving a stringent complete response or complete response (sCR or CR) per International Myeloma Working Group (IMWG) criteria. 102 of 117 patients (87%) were triple refractory, 48 of 117 patients (41%) were penta refractory, 21 of 117 patients (18%) had extramedullary disease, and 47 of 117 patients (40%) 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 (MRD) testing, 91 (95%) achieved MRD negativity at a median time of 1 month, meaning no cancer cells could be detected even with highly sensitive tests (≤10^-5 sensitivity).