US Food of Drug and Administration approved Axi-cel for treatment of DLBCL last year. European Commission approved it this year. Axi-cel is an anti-CD19 chimeric antigen receptor (CAR T). The receptor was tested in a trial and patients with diffuse large B-cell lymphoma and they were alive 2 years post-treatment. A study led by Sattva Neelapu and published in the online issues of Lancet Oncology says that “Axi-cel can induce durable remission in a substantial proportion of patients.” The receptor was safe to use and stood individually as an option where nothing else could treat DLBCL patient.
Phase-II trial was conducted for 101 patients in a time period of 27.1 months. A treatment called as an objective response when coupled with Axi-cel caused a reduction in cancer activity in 83% of patients. 58% of patients showed a complete response whereas 39% of patients showed an ongoing response. Once before this, a trial had been conducted for 15.4 months which showed similar results like Phase-II trial. Objective response rate, complete response rate, and the ongoing response rate were reported as 82%, 58%, and 42% respectively.
Patients in which ongoing response was seen, they were tested to analyze CAR-T cell persistence and B-cell recovery. Evaluable biomarker samples were obtained. In 24 months persisting CAR gene cells were seen in 66% of patients. Peripheral blood B-cells were measurable in 75% of patients.
Axi-cel after being approved by FDA was tested in ZUMA-1 study where 274 patients were assessed. Safety appears comparable to ZUMA-1 trial. Until the day 90, 81% of patients showed an objective response whereas complete response was in 57% patients. Data from 17 centers were obtained for real-world retrospective study which was free from manufacturer-funded trial. 90-day responses were thought to be as the best ever response observed in pivotal ZUMA-1 trial.