New clinical research and real-world evidence for Yescarta (axicabtagene ciloleucel (Axi-Cel)) demonstrate benefit From earlier lines of treatment

Results  include a comparative analysis of real-world and clinical trial data (abstract P1425), 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.

“We are committed to improving survival outcomes for people living with difficult-to-treat blood cancers,” said Ibrahim Elhoussieny, Vice President, Medical Affairs, Kite. “These new data support the potential benefit of utilizing Yescarta in earlier lines of treatment, both in terms of manufacturing success and product characteristics. Additional data support the safety and feasibility of administering CAR T-cell therapy in the outpatient setting. These data contribute to the body of evidence for efficient utilization and delivery of Yescarta and Tecartus and further support our ambition for patients.”

Abstract P1425: Real-World Manufacturing Experience of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Large B-Cell Lymphoma Treated in Second Line versus Third Line of Therapy and Beyond; . 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 (95.08% of 1,341 patients) achieved first-pass manufacturing success rate (FP-MSR); compared with patients treated third-line and beyond (92.48% of the 2,834). 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 naïve-like T-cells in apheresis among evaluable patients from ZUMA-1 (third-line) and ZUMA-7 (second-line). The analysis found the median percentage of naïve-like T-cells in patient leukapheresis was 9.28% (range, 0.20-45.07; n=126; P<.0001) for second-line, versus 4.11% (range, 0.09-56.60; n="100)" for third-line plus; demonstrating patients treated in second-line setting displayed a median of approximately two times as many naïve-like t-cells versus third-line plus patients. these results indicate capturing a greater naïve-like t-cell population in the initial leukapheresis material with earlier car t-cell therapy intervention, which is numerically associated with improved response.

“These data suggest a notable number of patients living with relapsed/refractory large B-cell lymphoma could benefit from receiving axi-cel as second-line versus third-line treatment and beyond,” said Dr. Jason Westin, study lead and Director of Lymphoma Clinical Research Program and Section Chief of Aggressive Lymphoma research team at The University of Texas MD Anderson Cancer Center. “Patients treated in second-line have both a higher rate of success of having their cell therapy manufactured at the first attempt, as well as twice as many, naïve-like T-cells collected during leukapheresis, both of which support patients potentially having a shorter vein-to-vein time. When combining these two factors, we hope this will lead to improved patient outcomes.”

Additional Data Presented for Outpatient Administration; Kite will presented 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.

Abstract P1159: ZUMA-24 Preliminary Analysis: A Phase II Study of Axicabtagene Ciloleucel in the Outpatient Setting with Prophylactic Corticosteroids in Patients with Relapsed/Refractory Large B-Cell Lymphoma; ZUMA-24 is an ongoing, single-arm, open-label, multicenter, Phase II study evaluating the safety and efficacy of Yescarta with prophylactic corticosteroid use in patients with R/R LBCL, after one or more prior lines of therapy, in the outpatient setting. The preliminary analysis of 30 patients who underwent outpatient dosing of Yescarta, after a median follow-up of five months, demonstrated that the safety and efficacy of Yescarta was consistent with previous clinical and real-world studies.

Abstract P1191: Updated Trends in Real-World Outpatient (OP) Administration of Axicabtagene Ciloleucel (Axi-Cel) and Brexucabtagene Autoleucel (Brexu-Cel) in Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL); A real-world outpatient study assessed trends in safety and hospitalization for patients with R/R Non-Hodgkin lymphoma (NHL) who received Yescarta and Tecartus at Mayo Clinic. Safety endpoints included CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hospitalization rates. Analysis of safety trends reported that outpatient administration of Yescarta and Tecartus was possible without added toxicity.