Gilead’s Yescarta Demonstrates Improvement in Overall Survival for Aggressive Blood Cancers

The Phase III ZUMA-7 study demonstrated event-free survival (EFS) at the primary endpoint, outperforming the historical standard of care (SOC) treatment. Patients who had received CD19-directed CAR-T cell therapy lived longer than the multistep regimen of chemoimmunotherpy, high-dose therapy and stem cell transplant SOC.

ZUMA-7, the first and largest Phase III study of any CAR T-cell therapy, evaluated the safety and efficacy of Yescarta versus SOC for the initial treatment of adult patients with R/R LBCL within 12 months of first-line therapy. The primary end-point (EFS) was determined by the blind central review: from the time of randomization to the earliest date of disease progression, the commencement of new lymphoma therapy, or death from any cause.

The ZUMA-7 trial designs, clinical endpoints and statistical analysis were already agreed upon prior to trial by the FDA under a Special Protocol Assessment. Overall survival was deemed a clinical key secondary endpoint, known as the length of time from randomization to death from any cause.

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Patients who were alive at two years and did not experience cancer progression or required the need for additional cancer treat increased by 2.5-fold under the treatment of Yescarta compared to SOC. In the blind study, 85% of patients responded to Yescarta (50% to SOC) and 65% achieved a complete response with Yescarta compared to SOC (32%).

To date, Yescarta has been approved for R/R LBCL in Great Britain, Japan, Israel and Switzerland and there are plans to present the data in full later this year.

Source: Kite Pharma Press Release

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