Yescarta Demonstrates Promise in Treating Relapsed/Refractory Large B-Cell Lymphoma

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Data from the CIBMTR trial demonstrated that Kite’s Yescarta (axicabtagene ciloleucel) produced high overall survival (OS), objective response rate (ORR), complete response (CR), and effectiveness consistent with pivotal trial outcomes in treating patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). According to the company, the analysis included real-world evidence (RWE) from the largest analysis of second-line treatment with Yescarta in 2022-2023 based on Center for International Blood and Marrow Transplant Research (CIBMTR) registry data.¹

“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,” said Dominique Tonelli, VP, global head, medical affairs, Kite, in a press release. “By studying outcomes in the real world, we consistently demonstrate that patients treated with Yescarta have the opportunity to live longer.”

In abstract #526, 446 patients from 89 centers in the United States from the CIBMTR registry who received second-line Yescarta treatment showed outcomes consistent with the ZUMA-7 trial, with a demonstrated ORR of 79% with a CR rate of 64%. Additionally, the one-year rate of duration of response was 66%, progression-free survival (PFS) rate was 53%, event-free survival was 53%, and OS was 71%.¹

“It is reassuring that the largest real-world dataset for axi-cel as a second-line treatment for relapsed/refractory large B-cell lymphoma, across a broader patient population than the ZUMA-7 pivotal study or Phase II ALYCANTE study for transplant-ineligible patients, has demonstrated consistent outcomes at 12-months median follow-up as in ZUMA-7,” said lead investigator Caroline Lee, fellow, hematology medical oncology, Stanford Medicine, in the press release. “These data should provide further confidence to physicians that earlier use of [Yescarta] can provide the best chance for overall survival and possibly a cure for these patients.”

In abstract #527, RWD from 615 patients with R/R LBCL from 109 centers from the CIBMTR registry demonstrated a decreasing trend in incidence, severity, and duration of cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome following treatment with Yescarta in the third-line setting. Additionally, these patients had significantly lower incidences of Grade ≥ 3 CRS compared to those treated during 2017–2019. Further, patients treated in the later time periods of 2022-2023 and 2020-2021 experienced significantly shorter duration of CRS compared to 2017-2019.¹

Lastly, in abstract #4505, findings from the Phase II ALYCANTE study in patients with R/R LBCL after one prior line of therapy who were deemed ineligible for high-dose chemotherapy and autologous stem cell transplantation found that after a short initial deterioration at one month post-infusion, patients reported longer-term stability or improved quality of life across multiple parameters, after up to a year of follow-up. Results found that 61 patients reported a lower symptomatic level at three months compared to baseline. After three months, 45% of patients presented 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.

“ALYCANTE is the first study to assess [Yescarta] as second-line therapy in transplant-ineligible relapsed/refractory large B-cell lymphoma patients, with previous study findings confirming its efficacy in this patient population,” said Roch Houot, head, hematology department, University Hospital of Rennes, France, coordinator, ALYCANTE study, in the press release. “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.”

Reference

1. Kite Presents New Data Underscoring Curative Potential of Yescarta® in Relapsed/Refractory Large B-cell Lymphoma at ASH. Gilead. December 8, 2024. Accessed December 9, 2024. https://www.gilead.com/news/news-details/2024/kite-presents-new-data-underscoring-curative-potential-of-yescarta-in-relapsedrefractory-large-b-cell-lymphoma-at-ash