Kite announces new Yescarta data from ZUMA-1
Kite, a Gilead Company, announced findings from two new analyses from the ZUMA-1 trial of Yescarta in adult patients with relapsed or refractory large B-cell lymphoma. These results include a two-year sub-population analysis of efficacy and safety in ZUMA-1 patients by age, as well as preliminary data from a separate safety management study of patients receiving early steroid intervention for cytokine release syndrome and neurologic events. The results were presented at the 2019 American Society of Clinical Oncology Annual Meeting. Yescarta was the first CAR T cell therapy approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Two-Year Analysis of ZUMA-1 by Age Supports Clinical Benefit of Yescarta in Patients 65 and Older: Patients with relapsed large B-cell lymphoma in the two-year follow-up of ZUMA-1 were analyzed in two groups - those 65 years or older and those younger than 65 years. With a median follow-up of 27.1 months, the objective response rate per investigator assessment was 92 percent among greater than or equal to65 patients and 81 percent in the less than65 group, with 75 percent and 53 percent of patients in the respective groups achieving a complete response. At two years, 42 percent of greater than or equal to65 patients and 38 percent of less than65 patients were in an ongoing response. The 24-month overall survival rate was 54 percent and 49 percent in each respective group. Among all patients in the safety analysis, most experienced Grade greater than or equal to3 adverse events. Grade greater than or equal to3 neurologic events occurred in 12 patients greater than or equal to65 and in 23 patients less than65. Grade greater than or equal to3 CRS occurred in 2 patients greater than or equal to65 and in 10 patients less than65. Kite is currently conducting various studies to further evaluate the efficacy and safety profile of Yescarta, including clinical trials evaluating use of bridging chemotherapy and other combination approaches. In a ZUMA-1 safety management study, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention beginning when patients experienced Grade 1 neurologic events and at Grade 1 CRS when no improvement was observed after three days of supportive care. As of the abstract data cut-off, 21 of 40 planned patients had received Yescarta, with a median follow-up of 7.7 months; 76 percent of patients received corticosteroids and 86 percent received tocilizumab. Grade greater than or equal to3 adverse events occurred in 95 percent of patients; Grade greater than or equal to3 events included decreased neutrophil count and anemia. Grade 1 or 2 neurologic events and CRS occurred in 48 percent and 100 percent of patients, respectively. No patients experienced Grade greater than or equal to3 CRS, and Grade greater than or equal to3 neurologic events occurred in only 10 percent of patients, both numerically lower than in the registrational cohorts of ZUMA-1. There were no deaths due to adverse events in Cohort 4. ORR per investigator assessment was 81 percent in the cohort, and 62 percent of patients achieved a complete response. The median duration of response has not yet been reached.