New data for Tecartus demonstrates durable responses at one year in ZUMA-2 trial follow-up in relapsed or refractory mantle cell lymphoma- Kite/Gilead

Kite, a Gilead Company, announced follow-up results from the pivotal ZUMA-2 trial of Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in adult patients with relapsed or refractory mantle cell lymphoma (MCL). At a median follow-up of 17.5 months (n= 60 evaluable for efficacy), 92 percent of patients had achieved a response, including 67 percent with a complete response (CR). Secondary endpoints of median duration of response, progression-free survival (PFS) and overall survival (OS) all were not yet reached. These data were presented at the 62nd ASH Annual Meeting and Exposition (Abstract #1120). Among all efficacy-evaluable patients (n=60), 48 percent had ongoing responses at data cut-off. Estimates for PFS and OS at 15 months were 59 percent and 76 percent, respectively. The first 28 patients treated had a median follow-up of 32.3 months, and 39 percent of these patients remain in remission with no further therapy. Among all patients (n=68), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events (NE) occurred in 15 percent and 31 percent of patients, respectively. No new Grade 5 events occurred with additional follow-up. “Patients with mantle cell lymphoma face a disease that often becomes more aggressive over time and nearly always relapses after initial therapy,” said Michael Wang, MD, Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. “Many patients with relapsed or refractory MCL will have high-risk disease that is more likely to keep progressing after treatment, so our goal with any therapy is to provide durable remission. With more than half of the patients in the ZUMA-2 trial still alive at nearly one and a half years after infusion, these results reinforce brexucabtagene autoleucel’s potential to address the gap in existing treatment.”