Kite, a Gilead Company, has presented new findings demonstrating the safety, efficacy and quality of life benefits offered by second-line Yescarta (axicabtagene) treatment for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Four-year data from the phase 3 ZUMA-7 study of Yescarta for R/R LBCL was analysed, as well as two-year data from the phase 2 ALYCANTE study of transplant-ineligible patients. Analyses evaluated 178 patients from the ZUMA-7 study and 69 patients from the ALYCANTE study.
Pooled analysis of the two studies showed an overall survival rate of 64.9%. Event-free survival was 45.2% overall, and progression-free survival was 47.4%. After three months, 55.6% of patients showed a complete metabolic response (CMR), meaning barely-detectable or undetectable disease.
Safety outcomes were found to be consistent between the two studies.
As well as efficacy in survival, Yescarta also demonstrated improvements in patients’ quality of life, with long-term treatment leading to patient-reported improvements in overall well-being.
LBCL is the most common type of non-Hodgkin lymphoma worldwide, with over 18,000 people diagnosed in the US annually. The need for second-line treatment in LBCL is high, with 30-40% of patients seeing their cancer either relapse or become refractory. Before the introduction of innovative treatments, such as chimeric antigen receptor T-cell (CAR-T) therapies, the two-year survival rate for R/R LBCL was around 20%.
Yescarta is a CD19-directed autologous T cell immunotherapy. It is indicated for the treatment of adults with LBCL that is refractory to first-line chemoimmunotherapy, or that relapses within 12 months of first-line chemoimmunotherapy. It is also indicated for adults with R/R LBCL following two or more lines of systemic therapy.
“This analysis offers compelling evidence of Yescarta’s consistent, durable efficacy and safety profile across a broad range of patients, including those with difficult-to-treat relapsed or refractory disease who historically faced very limited options and a poor prognosis,” said Gallia Levy, senior vice president and global head of development at Kite.