Gilead and Kite Oncology, announced that two poster presentations, covering results from two of the largest real-world analyses, will be presented during the 2023 Asia Pacific Blood and Marrow Transplantation Group (APBMT) annual meeting, in Semarang, Indonesia.

– Vein-to-vein time in CAR T-cell therapy may impact outcomes with relapsed/refractory large B-cell lymphoma in new CIBMTR analysis –

– Latest European analysis reinforces the 19-day commercial manufacturing turnaround time for axicabtagene ciloleucel in adult patients with relapsed/refractory large B-cell lymphoma –

Real-world analysis of the impact of time from leukapheresis to infusion in patient outcomes

A study that assessed real-world impact of time from leukapheresis to infusion (vein-to-vein time) in 1,383 adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) treated with Yescarta® (axicabtagene ciloleucel).[i] The patients were identified from a non-interventional post-authorization safety study using the Centre for International Blood and Marrow Transplant Research (CIBMTR) registry. The analysis reported shorter vein-to-vein times associated with improved outcomes in patients treated with axicabtagene ciloleucel, adjusted for key prognostic factors. (Poster ID 66).[ii]

Latest analysis reinforces the value of rapid and reliable manufacturing capability, high delivery success rates and improved turnaround time

A European analysis of commercial manufacturing experience of axicabtagene ciloleucel showed a median European manufacturing turnaround time of 19 days for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).[iii] The analysis included data from 2,432 European patients with R/R DLBCL who underwent leukapheresis (the collection of a patient’s white blood cells) and who received commercial axicabtagene ciloleucel between 6 September 2020 and 5 September 2022 and was compared to data from 1,115 European patients who underwent leukapheresis between 6 September 2018 and 5 September 2020. The analysis showed a reduced median manufacturing turnaround time from 25 days to 19 days for European patients with R/R DLBCL. An improvement in delivery success rate from 96% to 99% was also observed. 95% to 96% high manufacturing success rate was maintained during the analysis period. Manufacturing turnaround time is defined as time from day of leukapheresis to the day of product disposition for lots using fresh apheresis material. Delivery success rate is defined as the percentage of patients for whom a dose was shipped out of the total number of patients leukapheresed in the time period (excluding those patients lost in process and patients withdrawn). (Poster ID 65).ⁱⁱⁱ

“The findings of both analyses reinforce Kite’s global leadership in CAR T-cell therapy and our commitment to understanding the key factors that can contribute to the best possible outcomes for patients receiving this innovative therapy,” said Diego Santoro, General Manager, Intercontinental Region, Kite. “From shorter vein-to-vein time to rapid and reliable manufacturing capacity, we are committed to driving technical advances for patients in urgent need of additional options.”