Kite, a Gilead Company, has announced new data from three analyses of Yescarta (axicabtagene ciloleucel), demonstrating improved outcomes for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). The findings were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition.
The data includes results from the largest real-world analysis of patients receiving Yescarta as a second-line treatment for R/R LBCL, based on data from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry. This real-world evidence (RWE) shows high rates of overall survival (OS), overall response rate (ORR), and complete response (CR), consistent with outcomes from the ZUMA-7 trial. Additional RWE from CIBMTR indicates a decreasing trend in the incidence, severity, and duration of cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome (ICANS) in the third-line-plus setting.
Consistent Efficacy in Real-World Settings
According to Dominique Tonelli, VP, Global Head of Medical Affairs, Kite, "We are pleased that Yescarta’s overall survival benefit for patients with early relapsed/refractory large B-cell lymphoma is confirmed in the largest real-world analysis of a broader patient population. By studying outcomes in the real world, we consistently demonstrate that patients treated with Yescarta have the opportunity to live longer."
In abstract #526, the real-world analysis included 446 patients from 89 centers in the United States. The data showed an ORR of 79% (95% CI, 75-82) with a CR rate of 64% (95% CI, 60-69). The one-year duration of response (DOR) rate was 66% (95% CI, 59-71), progression-free survival (PFS) rate was 53% (48-58), event-free survival (EFS) rate was 53% (48-58), and OS was 71% (66-76).
Decreasing Trends in Treatment-Related Adverse Events
Abstract #527 presented RWE from 1,615 patients with R/R LBCL from 109 centers. The data demonstrated a decreasing trend in the incidence, severity, and duration of CRS and ICANS following Yescarta treatment in the third-line setting. Patients treated in 2022-2023 and 2020-2021 had significantly lower incidences of Grade ≥ 3 CRS compared to those treated during 2017-2019 (OR 0.17, 95% CI, 0.07-0.41, and OR 0.63, 95% CI, 0.43-0.94, respectively). Additionally, patients treated in later periods experienced significantly shorter durations of CRS compared to 2017-2019 (HR 1.36, 95% CI, 1.14-1.64, and HR 1.34, 95% CI, 1.18-1.52, respectively).
Improved Quality of Life
In abstract #4505, findings from the Phase II ALYCANTE study in patients with R/R LBCL ineligible for high-dose chemotherapy and autologous stem cell transplantation showed that patients reported longer-term stability or improved quality of life across multiple parameters after up to a year of follow-up. Results from 61 patients showed a lower symptomatic level at three months compared to baseline, with 45% of patients presenting a stable global health condition and 73% stable physical functioning. After a year, most patients reported a more stable condition, with clinically and statistically significant improvement.
According to Roch Houot, head of the hematology department at University Hospital of Rennes, France, and coordinator of the ALYCANTE study, "This current study shows that, in this frail and elderly population, [Yescarta] not only increased the quantity of life but also improved the quality of life which was comparable to that of the transplant-eligible patients, and allowed recovery of a fatigue score close to the general French population."
