Kite's CAR-T cell therapy Yescarta meets goal for LBCL

Gilead Sciences (Nasdaq: GILD) subsidiary Kite has released new data supporting the value of its already-approved chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel).

Kite announced results from the Phase II ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of Yescarta in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The full findings from the study were published in Nature Medicine.

The ALYCANTE study, a multicenter, open-label Phase II LYSA study, evaluated for the first time the efficacy and safety of axicabtagene ciloleucel as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT. The study met its primary endpoint, with a complete metabolic response (CMR) of 71% (n=44; 95% confidence interval [CI], 58.1%–81.8%) at three months versus 12% with standard of care (based on historical controls). At six months, 59.7% of patients (n=37) remained in CMR. CMR is defined as negative findings on a PET study during or following antitumor therapy.