Kite, a Gilead Company (GILD), has unveiled compelling new findings on Yescarta (axicabtagene ciloleucel) efficacy, with particular emphasis on survival metrics that position this CAR T-cell therapy as a transformative treatment option for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Survival Rates Paint a Striking Clinical Picture
The most striking revelation centers on survival achievements. At the two-year mark, overall survival (OS) rates reached 64.9% across pooled analysis, 62.8% in the Phase 3 ZUMA-7 trial, and 70.8% in the Phase 2 ALYCANTE study. These survival numbers represent a dramatic departure from historical baselines, where R/R LBCL patients faced approximately 20% two-year survival rates before CAR T-cell therapy became available. Such survival improvements underscore the therapy’s potential to fundamentally alter patient prognosis in this challenging disease setting.
Comprehensive Response Metrics
Beyond survival rates, additional efficacy measures reinforce Yescarta’s clinical value. Event-free survival (EFS) reached 45.2% in the pooled cohort, 45.4% in ZUMA-7, and 44.7% in ALYCANTE. Progression-free survival (PFS) mirrored this performance at 47.4%, 47.6%, and 46.8% respectively. Three months post-treatment, complete metabolic response (CMR) was achieved by 55.6% of patients pooled, with 51.2% in ZUMA-7 and 67.7% in ALYCANTE participants.
Notable Efficacy in Transplant-Ineligible Populations
The ALYCANTE study, specifically designed by the French collaborative LYSA group and sponsored by LYSARC, evaluated transplant-ineligible patients—a historically underserved population. The survival rates observed in ALYCANTE (70.8% OS at two years) stood notably higher than in ZUMA-7, suggesting Yescarta’s particular benefit for patients unsuitable for traditional high-dose chemotherapy followed by autologous stem cell transplant (ASCT).
Durable Response Profiles
Durability of therapeutic benefit emerged as another key finding. One year post-treatment, overall response rate (ORR) remained consistent at 46.6% pooled, 46.5% in ZUMA-7, and 46.8% in ALYCANTE. Among responding patients, 61% maintained responses at 12 months, with duration of response (DOR) rates of 61.0% pooled, 60.6% in ZUMA-7, and 62.1% in ALYCANTE. These durable survival and response profiles collectively demonstrate that Yescarta’s therapeutic benefits extend beyond initial response, offering sustained clinical value for eligible patients.
The analysis integrates four-year follow-up data from ZUMA-7 alongside two-year data from ALYCANTE, providing robust evidence of Yescarta’s consistent efficacy across diverse patient populations in second-line R/R LBCL treatment.
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Yescarta Delivers Robust Survival Outcomes in R/R Large B-Cell Lymphoma: New Analysis Across ZUMA-7 and ALYCANTE Studies
Kite, a Gilead Company (GILD), has unveiled compelling new findings on Yescarta (axicabtagene ciloleucel) efficacy, with particular emphasis on survival metrics that position this CAR T-cell therapy as a transformative treatment option for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Survival Rates Paint a Striking Clinical Picture
The most striking revelation centers on survival achievements. At the two-year mark, overall survival (OS) rates reached 64.9% across pooled analysis, 62.8% in the Phase 3 ZUMA-7 trial, and 70.8% in the Phase 2 ALYCANTE study. These survival numbers represent a dramatic departure from historical baselines, where R/R LBCL patients faced approximately 20% two-year survival rates before CAR T-cell therapy became available. Such survival improvements underscore the therapy’s potential to fundamentally alter patient prognosis in this challenging disease setting.
Comprehensive Response Metrics
Beyond survival rates, additional efficacy measures reinforce Yescarta’s clinical value. Event-free survival (EFS) reached 45.2% in the pooled cohort, 45.4% in ZUMA-7, and 44.7% in ALYCANTE. Progression-free survival (PFS) mirrored this performance at 47.4%, 47.6%, and 46.8% respectively. Three months post-treatment, complete metabolic response (CMR) was achieved by 55.6% of patients pooled, with 51.2% in ZUMA-7 and 67.7% in ALYCANTE participants.
Notable Efficacy in Transplant-Ineligible Populations
The ALYCANTE study, specifically designed by the French collaborative LYSA group and sponsored by LYSARC, evaluated transplant-ineligible patients—a historically underserved population. The survival rates observed in ALYCANTE (70.8% OS at two years) stood notably higher than in ZUMA-7, suggesting Yescarta’s particular benefit for patients unsuitable for traditional high-dose chemotherapy followed by autologous stem cell transplant (ASCT).
Durable Response Profiles
Durability of therapeutic benefit emerged as another key finding. One year post-treatment, overall response rate (ORR) remained consistent at 46.6% pooled, 46.5% in ZUMA-7, and 46.8% in ALYCANTE. Among responding patients, 61% maintained responses at 12 months, with duration of response (DOR) rates of 61.0% pooled, 60.6% in ZUMA-7, and 62.1% in ALYCANTE. These durable survival and response profiles collectively demonstrate that Yescarta’s therapeutic benefits extend beyond initial response, offering sustained clinical value for eligible patients.
The analysis integrates four-year follow-up data from ZUMA-7 alongside two-year data from ALYCANTE, providing robust evidence of Yescarta’s consistent efficacy across diverse patient populations in second-line R/R LBCL treatment.