Kite announces Alycante study met primary endpoint

Kite, a Gilead company, announced results from the Phase 2 Alycante study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its chimeric antigen receptor, or CAR, T-cell therapy Yescarta in patients with relapsed/refractory large B-cell lymphoma after one prior line of therapy who were deemed ineligible for high-dose chemotherapy and autologous stem cell transplantation. The full findings from the study were published in Nature Medicine. The Alycante study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta 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 of 71% at 3 months versus 12% expected with standard of care. At six months, 59.7% of patients remained in CMR. CMR is defined as negative findings on a PET study during or following antitumor therapy. Best objective response and complete response rates were 91.9% and 82.3%, respectively. After a median follow-up of 12 months, median progression-free survival from infusion was 11.8 months, and 48.8% of patients evaluated were alive and progression-free at 12 months. Median overall survival was not reached. OS at 12 months was 78.3%. Yescarta showed an acceptable safety profile in this population, who are considered unfit for HDCT/ASCT; 8.1% and 14.5% experienced Grade 3-4 cytokine-release syndrome or Immune Effector Cell Associated Neurotoxicity Syndrome, respectively. In clinical practice, about half of patients with R/R LBCL are considered ineligible for HDCT/ASCT due to factors including advanced age, frailty, and coexisting medical conditions. The Alycante study included patients deemed ineligible for HDCT/ASCT because of age 65 years, high hematopoietic cell transplantation-specific comorbidity index score of 3, and/or prior ASCT.