P022 | THE ITALIAN COMMERCIAL AXI-CEL MANUFACTURING PERFORMANCE: A RETROSPECTIVE ANALYSIS OF AN EFFICIENT AND RELIABLE PROCESS OVER TIME

Axicabtagene ciloleucel (axi-cel) is approved for patients (pts) with relapsed/refractory large B-cell lymphoma (R/R LBCL), with curative potential demonstrated in second-line (Westin et al. N Engl J Med 2021) and third- or later settings (Neelapu et al. Blood 2023). Kite’s excellent manufacturing process (Miklos abs 3477 ASH 2024, Casadei abs DP010 SIE 2024) can help reduce vein-to-vein time, supporting better response rates and survival outcomes (Locke et al. Blood Adv 2025). This study aims to explore Italian manufacturing metrics in pts with R/R LBCL (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and high grade B-cell lymphoma) treated with axi-cel in 2L or 3L+ during 2024. This analysis evaluated 430 unique pts registered in KiteKonnect®(KK) who received commercial axi-cel in Italy from 01/01/24 to 11/12/24. Outcomes included: Manufacturing Success Rate (MSR), defined as the percentage of those patient lots dispositioned by the Qualified Person as “released” or “physician’s release” out of the total number of lots dispositioned. First Pass MSR (FP-MSR) is defined as the percentage of first-attempt patient lots dispositioned as manufactured within specification out of the total number of first-attempt patient lots dispositioned plus those terminated (excluding those terminated for patient withdrawal). Delivery Success Rate (DSR) is defined as the percentage of pts lots shipped (dispositioned as Qualified Person released or physician’s released) out of the total number of pts leukapheresed (excluding lots in process and pts withdrawn). Turnaround Time (TAT) is the time from leukapheresis (LK) to product release among first-pass axi-cel lots manufactured using fresh LK material. As shown in Table 1, among all pts, FP-MSR improved from 95,2% in 2022-2023 to 96,7% in 2024. DSR is 100% and the median TAT (mTAT) was improved to 18 days. From 2022–2023 through 2024, ongoing improvements in axi-cel manufacturing for Italian pts have resulted in reliable FP-MSR, consistent DSR and a faster mTAT, aligning with global Kite manufacturing data. Axi-cel exhibits a predictable mTAT of 18 days, a critical factor for physicians when establishing a reliable treatment plan and enabling an optimized hospital capacity. The reliable, predictable, and effective production and delivery of axi-cel are intrinsically connected to survival outcomes, offering to pts a potentially curative treatment.