Kite Highlights Curative Potential of Yescarta® for Relapsed Large B-cell Lymphoma at ASH

Kite, a Gilead Company, headquartered in Santa Monica, California, recently presented findings from three new analyses regarding Yescarta® (axicabtagene ciloleucel) at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition. These findings highlight enhanced outcomes for individuals with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).

The first set of data originates from the largest real-world analysis of patients treated with Yescarta as a second-line treatment for R/R LBCL during 2022-2023. This analysis, sourced from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, encompasses 446 patients from 89 U.S. centers. The results indicate high overall survival (OS) rates, overall response rate (ORR), and complete response (CR), aligning with the outcomes observed in the ZUMA-7 study. Among these patients, the ORR was 79%, with a CR rate of 64%. Additionally, the 12-month rates for duration of response (DOR), progression-free survival (PFS), event-free survival (EFS), and OS were 66%, 53%, 53%, and 71%, respectively. Incidence rates for cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome (ICANS) were 87% and 50%, respectively, with Grade ≥3 incidences at 5% and 22%.

The second analysis focuses on real-world trends in CRS and ICANS among 1,615 patients treated with Yescarta in the third-line-plus setting. Data from 109 U.S. centers between 2017 and 2023 reveal a decreasing trend in the incidence, severity, and duration of these adverse events. Patients treated during 2022-2023 and 2020-2021 had significantly fewer and less severe occurrences of Grade ≥3 CRS compared to those treated in 2017-2019. The use of treatments like tocilizumab and corticosteroids remained consistent, with an increasing use of anakinra observed over time.

The third analysis, stemming from the Phase 2 ALYCANTE study, examines health-related quality of life (HRQoL) outcomes following Yescarta treatment. Conducted by the French collaborative group The Lymphoma Study Association/Lymphoma Academic Research Organization (LYSA/LYSARC) and Kite, this study involved 61 patients who were ineligible for high-dose chemotherapy and autologous stem cell transplantation. The study reported initial deterioration in HRQoL at one month post-infusion, followed by stability or improvement over time. At three months, patients experienced lower symptomatic levels, with significant improvements noted in pain, emotional impact, and health-related worries. At 12 months, 45% of patients maintained stable global health, and 73% had stable physical functioning.

Dr. Dominique Tonelli of Kite emphasized the significance of these findings, noting that the analyses confirm Yescarta’s survival benefit in a broader patient population. Dr. Dasom (Caroline) Lee, Lead Investigator and Fellow at Stanford Medicine, highlighted that these real-world data provide confidence in Yescarta’s efficacy as a second-line treatment, potentially offering patients a better chance at survival and possibly a cure.

Yescarta, a CD19-directed genetically modified autologous T cell immunotherapy, is approved for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of such treatment. It is also approved for those with relapsed or refractory LBCL after two or more lines of systemic therapy and for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy. These approvals are based on the ZUMA-7 study's results and other clinical trials, reinforcing Yescarta's role in improving patient outcomes in challenging lymphoma cases.

The comprehensive data from these studies provide a robust foundation for the continued use and evaluation of Yescarta in treating R/R LBCL, highlighting its potential to enhance patient survival and quality of life significantly.