Gilead's Kite announces long-term data from ZUMA-1 study in lymphoma
Kite, a Gilead company, announced new data from the ZUMA-1 trial of Yescarta in adult patients with refractory large B-cell lymphoma. These results included updated overall survival data from the pivotal Phase 2 study after three years following a single infusion of Yescarta, as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome and neurologic events. The data were presented today at the American Society of Hematology Annual Meeting. With a minimum follow-up of three years after a single infusion of Yescarta, median follow-up of 39.1 months, approximately half of patients with refractory large B-cell lymphoma in ZUMA-1 pivotal Phase 2 cohorts were alive, and the median overall survival was 25.8 months. These updated three-year survival data were presented as part of a ZUMA-1 analysis evaluating mechanism of secondary treatment failure following treatment with Yescarta. Updated results from a separate ZUMA-1 safety management study were also presented at the meeting. In this analysis, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention, beginning when patients experienced Grade 1 neurologic events or experienced Grade 1 CRS with no improvement after three days of supportive care. Patients could receive optional bridging chemotherapy prior to Yescarta infusion. Objective response rate per investigator assessment was 73% in Cohort 4, with 51% of patients achieving a complete response.