Gilead announces results from three new analyses for Yescarta at EHA

Kite, a Gilead company, announced results from three new analyses for Yescarta in relapsed/refractory large B-cell lymphoma, or LBCL, including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus at the 2024 European Hematology Association, or EHA, annual congress, June 13-16, Madrid. Results include a comparative analysis of real-world and clinical trial data, which show higher manufacturing success rate and improved T-cell performance for Yescarta in second-line versus third-line plus treatment of R/R LBCL. Rapid and efficient manufacturing of CAR T-cell therapy can help reduce the time from leukapheresis to cell therapy infusion. An analysis of 4,175 patients compared the real-world manufacturing experience and clinical trial product characteristics for patients with R/R LBCL in second-line versus third-line plus treatment. The analysis found a statistically significant higher number of patients with R/R LBCL who received Yescarta as a second-line treatment achieved first-pass manufacturing success rate; compared with patients treated third-line and beyond. This 2.60% difference suggests that 26 more lots of Yescarta are successfully manufactured per 1,000 in the first attempt for patients in second-line versus patients in third-line or beyond. The FP-MSR is defined as the ability to manufacture and disposition patient lots within specification at first attempt, critical to maintaining a timely and dependable manufacturing process. Given that higher FP-MSR lessens the need for multiple manufacturing attempts, patients receiving Yescarta in second-line could potentially experience shorter vein-to-vein times. Results further assessed the percentage of naive-like T-cells in apheresis among evaluable patients from ZUMA-1 and ZUMA-7. The analysis found the median percentage of naive-like T-cells in patient leukapheresis was 9.28% for second-line, versus 4.11% for third-line plus; demonstrating patients treated in second-line setting displayed a median of approximately two times as many naive-like T-cells versus third-line plus patients. These results indicate capturing a greater naive-like T-cell population in the initial leukapheresis material with earlier CAR T-cell therapy intervention, which is numerically associated with improved response. Kite will also present two studies which evaluate the safety and efficacy of cell therapy administration within the outpatient setting. Preliminary findings, including safety data, from the ZUMA-24 study suggest that outpatient administration of Yescarta is feasible, when administered at a qualified treatment center, at the physician’s discretion with appropriate monitoring. The REMS program for healthcare facilities that dispense and administer Yescarta is described in greater detail below.