Large Molecule

Gilead rolls out new CAR-T data at ASCO

Jun 03, 2019

Gilead's Kite announced findings from new analyses of CAR-T treatments at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Findings from two new analyses from the ZUMA-1 trial of Yescarta in adult patients with relapsed or refractory large B-cell lymphoma 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 (CRS) and neurologic events.

Yescarta, approved in 2017, was the first CAR-T cell therapy approved by the U.S. FDA.

Kite also announced results from the completed Phase 1 ZUMA-3 study evaluating KTE-X19, an investigational CAR-T cell therapy. ZUMA-3 is a single-arm Phase 1/2 study in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). The results provide guidance on dosing and safety management for KTE-X19 to inform the ongoing Phase 2 study.