Gilead’s Yescarta Bests Long-Time Standard of Care in R/R LBCL Overall Survival

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In a Phase III reveal Tuesday, Gilead’s Kite Pharma reported Yescarta is the first treatment in nearly 30 years to improve overall survival (OS) in relapsed/refractory large B-cell lymphoma (R/R LBCL).

In the Zuma-7 study, patients who received the CD19-directed CAR-T cell therapy lived longer compared to the current standard of care, a multistep regimen that involves a chemoimmunotherapy regimen and stem cell transplant. This SOC has been in place for nearly three decades.

Overall survival, a key secondary endpoint, was defined as time from randomization to death from any cause. Kite previously demonstrated that patients on Yescarta were 2.5 times more likely to be alive at two years without disease progression or the need for additional treatment.

Zuma-7 was conducted under a Special Protocol Assessment with the FDA in which both the company and regulator agreed on the trial design, clinical endpoints and statistical analysis prior to initiating the study.

Other regulatory authorities were also on board with the analysis, according to Kite.

The study also met its primary endpoint of event-free survival, demonstrating superiority to historical standard of care. Kite used data from the Zuma-7 pivotal trial to support Yescarta’s approval in this indication in April 2022. EU approval was granted in October 2022 for the initial treatment of R/R LBCL.

Yescarta is also approved for RR LBCL in Great Britain, Israel, Japan and Switzerland.

Kite plans to present full data from Zuma-7 at a scientific meeting later this year.

Yescarta is in competition with Bristol Myers Squibb’s CAR-T cell therapy Breyanzi, which the FDA approved in June 2022 for the second-line treatment of R/R LBCL.

Initially approved in 2017, Yescarta is fueling Gilead’s sales. Revenues from the drug increased to $337 million in 4Q 2022, primarily due to greater demand for R/R LBCL therapies in the U.S. and EU. Breyanzi, initially approved in 2021, brought in $182 million for BMS in 2022.

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