Press release
Kite’s Car T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma
– Yescarta Achieved a Complete Metabolic Response (CMR) of 71% at 3 Months Versus 12% Expected with Historical Standard of Care Controls – – Results
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Yescarta Achieved a Complete Metabolic Response (CMR) of 71% at 3 Months Versus 12% Expected with Historical Standard of Care Controls –\n\n\n– Results Published in Nature Medicine–\n\n\n SANTA MONICA, Calif.--(BUSINESS WIRE)--\nKite, a Gilead Company (Nasdaq: GILD), today 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 (CAR) T-cell therapy Yescarta® (axicabtagene ciloleucel) 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.\n\n\nThe 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 (CMR) of 71% (n=44, 95% confidence interval [CI], 58.1%–81.8%) at 3 months versus 12% expected with standard of care (based on historical controls). At 6 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.\n\n\n“Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Prof. Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study. “ALYCANTE is the first study to assess axicabtagene ciloleucel as second-line therapy for transplant ineligible R/R LBCL and the results showed high response rates and durable remission in this hard-to-treat population.”\n\n\nBest objective response (OR) and complete response (CR) rates were 91.9% (n=57) and 82.3% (n=51), respectively. After a median follow-up of 12 months, median progression-free survival (PFS) from infusion was 11.8 months, and 48.8% (95% CI, 34.0-62.0%) of patients evaluated were alive and progression-free at 12 months. Median overall survival (OS) was not reached. OS at 12 months was 78.3% (95% CI, 64.7-87.1%). Yescarta showed an acceptable safety profile in this population, who are considered unfit for HDCT/ASCT; 8.1...