First Treatment in Nearly 30 Years to Show Statistically Significant OS, With a Median Follow-Up of 47.2 Months, for Initial Treatment of R/R LBCL Versus Historical SOC in the Curative Setting --

-- Yescarta Results in a 27.4% Reduction in Risk of Death, Corresponding to a 38% Relative Improvement in OS, Despite 57% of Patients Subsequently Receiving Cell Therapy Off Protocol --

-- Data Highlighted as Late-Breaking News at ASCO 2023 and Simultaneously Published in the New England Journal of Medicine --

Kite, a Gilead Company (NASDAQ:GILD), today announces detailed results from the overall survival (OS) analysis of the landmark Phase 3 ZUMA-7 study of Yescarta^® (axicabtagene ciloleucel [axi-cel]) CAR T-cell therapy compared with historical standard of care (SOC) as initial treatment in the curative setting for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL). Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival in this patient population. The late-breaking data are being presented orally at the 2023 American Society of Clinical Oncology Annual Meeting (Abstract #LBA107) and published simultaneously in the New England Journal of Medicine.

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With a median follow-up of 4 years (47.2 months), a one-time treatment with Yescarta demonstrated significantly longer overall survival (hazard ratio [HR] 0.726; 95% CI: 0.540-0.977, stratified one-sided log rank p-value = 0.0168) compared to SOC with a 27.4% reduction in the risk of death, which corresponds to a 38% relative improvement in overall survival, for patients with R/R LBCL within 12 months completion of first-line therapy.

SOC therapy for this patient population has historically been a multi-step process expected to end with stem-cell transplant. The process starts with chemoimmunotherapy, and if a patient responds and can tolerate further treatment, they move on to high-dose chemotherapy (HDT), followed by stem cell transplant (ASCT). It is notable that despite this process being the historical SOC, less than 40% of patients were able to make it through to complete their stem cell transplant compared with 94% of patients in the ZUMA-7 study who received Yescarta CAR T-cell therapy.