Kite Research Shows Yescarta® Benefits from Earlier Treatment

Kite, a Gilead Company, has unveiled significant findings from three new studies on Yescarta® (axicabtagene ciloleucel) for treating relapsed/refractory large B-cell lymphoma (R/R LBCL). The data presented at the 2024 European Hematology Association (EHA) Annual Congress in Madrid focus on manufacturing efficiency and outpatient administration, emphasizing the potential benefits of Yescarta in earlier treatment stages.

The first study, Abstract P1425, highlights the manufacturing success rates of Yescarta. The analysis, which included 4,175 patients, compared real-world data with clinical trial outcomes for those receiving Yescarta as either a second-line or third-line-plus treatment. Results demonstrated a higher first-pass manufacturing success rate (FP-MSR) in second-line treatments (95.08% of 1,341 patients) compared to third-line and beyond (92.48% of 2,834 patients). This 2.60% improvement in second-line treatments indicates that 26 more lots of Yescarta are successfully manufactured per 1,000 in initial attempts versus later lines.

The study also assessed T-cell performance, revealing that second-line treatment patients had a median of 9.28% naïve-like T-cells in leukapheresis material, significantly higher than the 4.11% seen in third-line-plus patients. This suggests that early intervention with CAR T-cell therapy could capture more naïve-like T-cells, which are associated with improved patient responses.

Dr. Jason Westin, lead of the study and Director of the Lymphoma Clinical Research Program at The University of Texas MD Anderson Cancer Center, remarked that these findings suggest significant benefits for patients receiving Yescarta in second-line treatments versus later stages. Patients in earlier treatment stages not only have higher manufacturing success but also have a greater volume of naïve-like T-cells, potentially reducing the time from leukapheresis to infusion and improving overall patient outcomes.

In addition to manufacturing efficiency, Kite presented data on the outpatient administration of Yescarta and Tecartus® (brexucabtagene autoleucel). Abstract P1159 from the ZUMA-24 study demonstrated the feasibility of outpatient administration with prophylactic corticosteroids in 30 patients who had a median follow-up of five months. The safety and efficacy observed were consistent with previous studies, suggesting that outpatient administration is viable with appropriate monitoring.

Another study, Abstract P1191, evaluated real-world trends in outpatient administration of Yescarta and Tecartus at Mayo Clinic. The findings indicated that outpatient administration did not increase toxicity, making it a potential option for treating patients with R/R non-Hodgkin lymphoma (NHL).

These studies collectively underscore the benefits of using Yescarta in earlier lines of treatment and its feasibility in outpatient settings, paving the way for broader and more efficient CAR T-cell therapy delivery.