Kite's CAR-T Therapy Yescarta Meets Primary Endpoint in Phase 2 Trial for Second-Line Treatment of Lymphoma Patients Ineligible for Stem Cell Transplant

▎WuXi

Edited by Kant Content Team

Recently, a Phase 2 clinical trial of the CAR-T cell therapy Yescarta (axicabtagene ciloleucel), developed by Kite, a subsidiary of Gilead Sciences, yielded positive results, with detailed findings published in the journal Nature Medicine. The trial aimed to evaluate the efficacy and safety of Yescarta as a second-line treatment for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are ineligible for autologous stem cell transplantation (ASCT).The study met its primary endpoint, with a 71.0% complete metabolic response rate assessed by investigators at 3 months after Yescarta infusion. These results support the use of Yescarta as a second-line therapy for R/R LBCL patients who are ineligible for ASCT.

Malignant lymphoma is divided into Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Large B-cell lymphoma (LBCL) is the most common type of NHL. Due to cancer recurrence or lack of response, approximately 30-40% of LBCL patients require second-line therapy. The historical standard treatment is a multi-step process, involving a chemoimmunotherapy regimen containing platinum-based drugs for patients who respond to salvage chemotherapy, followed by high-dose therapy (HDT) and stem cell transplantation.

Yescarta is the second CAR-T cell therapy approved by the FDA. It targets the CD19 antigen on the surface of B cells, guiding and activating T cells to kill cancerous B cells. Results from a previous Phase 3 clinical trial, ZUMA-7, showed,For R/R LBCL patients considered eligible for ASCT, Yescarta demonstrated superior efficacy as a second-line therapy compared to standard care.The FDA approved Yescarta for the second-line treatment of adult patients with LBCL who are refractory to first-line chemoimmunotherapy or relapse within 12 months after receiving first-line therapy. However,In clinical practice, approximately half of R/R LBCL patients are considered ineligible for ASCT, and the efficacy of Yescarta in such patients remains to be determined.

The ALYCANTE study, whose results were recently published, is an open-label Phase 2 clinical trial designed to evaluate the efficacy of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for ASCT. The primary endpoint of the study was the complete metabolic response rate assessed by investigators three months after Yescarta infusion. Key secondary endpoints included progression-free survival, overall survival, and safety.

Study Meets Primary Endpoint, the complete metabolic response rate at 3 months was 71.0%.(95% CI: 58.1-81.8%). The median follow-up time was 12.0 months (2.1-17.9 months).The median progression-free survival for patients was 11.8 months.(95% CI: 8.4-not yet reached), overall survival not yet reached. In terms of safety, no unexpected toxicity events occurred. Grade 3-4 cytokine release syndrome and neurological events occurred in 8.1% and 14.5% of patients, respectively. These results support the use of Yescarta as a second-line therapy for R/R LBCL patients who are ineligible for ASCT.

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