Yescarta® demonstrates promising European manufacturing experience
Posted: 24 April 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
In newly published analysis, Kite’s CAR T-cell therapy delivered a reduced median European manufacturing turnaround time for diffuse large B-cell lymphoma (DLBCL) patients.
Yescarta® (axicabtagene ciloleucel or axi-cel) has achieved a median European commercial manufacturing turnaround time of 19 days for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). New European analysis of the CAR T-cell therapy showing these results were presented at the 2023 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).
This turnaround time was compared to 25 days from the initial two-year analysis in 2020.
“This new analysis reinforces our global manufacturing turnaround time data, and the consistency of our delivery success rates,” explained Chris McDonald, Global Head of Technical Operations at Kite.
Kite defined manufacturing turnaround time as time from day of leukapheresis to the day of product disposition for lots using fresh apheresis material.
Manufacturing a CAR T-cell therapy
An improvement in delivery success rate since the initial two-year period, from 99 percent versus 96 percent, was also observed”
An improvement in delivery success rate since the initial two-year period, from 99 percent versus 96 percent, was also observed. The company defined delivery success rate as the percentage of patients for whom a dose was shipped out of the total number of patients leukapheresed in the time period.
Data from the EBMT meeting also stated that the number of patients included in the latest two-year analysis more than doubled.
The analysed data was sourced from 2,432 European patients with R/R DLBCL who underwent leukapheresis and who received commercial axicabtagene ciloleucel between 6 September 2020 and 5 September 2022. This was with patient lots delivered to treatment centres across the European Union, UK, Switzerland and Israel.
This first dataset was compared to data from 1,115 European patients who underwent leukapheresis between 6 September 2018 and 5 September 2020.
McDonald commented on the importance of the new analysis of the CAR T therapy: “Research shows manufacturing turnaround times may be associated with better patient outcomes.”
Facilitating access to the cell therapy
In January 2023, Yescarta became the first CAR T therapy to be recommended for routine NHS use for DLBCL patients in England. The personalised immunotherapy was accepted for use in these patients in the third line setting.
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