
Anitocabtagene autoleucel (anito-cel), a D-domain BCMA-directed chimeric antigen receptor (CAR) T-cell therapy, demonstrated robust efficacy in the treatment of relapsed or refractory multiple myeloma (MM), according to a study presented at the Society of Hematologic Oncology 2024 Annual Meeting.
In this study, researchers analyzed 40 patients, 38 of whom received anito-cel (32, DL1; 6, DL2). The primary end points were incidence of adverse events and dose-limiting toxicities. All infused patients were triple-refractory, 26 (68%) were penta-refractory, 9 (24%) had high tumor burden, 13 (34%) had extramedullary disease, and 11 (29%) had high-risk cytogenetics, the researchers noted.
According to the results, all patients achieved a response as assessed by investigators per 2016 International Myeloma Working Group criteria of which 22 achieved a stringent complete response (sCR) and seven achieved a CR (≥CR rate, 76%).
Conversions to sCR occurred from one to 12 months or longer. Median duration of response, progression-free survival (PFS), and overall survival were not reached; Kaplan-Meier estimated PFS rates for 6, 12, 18, and 24 months were 92%, 76%, 64%, and 56%, respectively. The investigators observed durable responses in patients with high-risk features, age ≥65 years, and high-risk cytogenetics, which were consistent with the overall study population.
“Adverse events with anito-cel were manageable and resolved; no delayed neurotoxicity, cranial nerve palsies, nor Parkinsonian-like events were observed at time of data cut. Efficacy analyses demonstrated 100% ORR, with 76% ≥CR. Responses were durable, with an estimated 24-month PFS rate of 56% and comparable outcomes in patients with high-risk disease,” the researchers concluded.
Reference
Frigault M, Rosenblatt J, Dhakal B, et al. Phase 1 study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: results from at least one-year follow-up in all patients. Abstract #MM-364. Presented at the Society of Hematologic Oncology 2024 Annual Meeting; September 4-7, 2024; Houston, Texas.