Kite releases pivotal CAR T therapy Phase III study results
Yescarta® is the first treatment in over 30 years to show statistically significant improvement in overall survival in R/R large B-cell lymphoma versus historical SOC.
ZUMA-7 is the first and largest Phase III study of any CAR T-cell therapy, with the longest follow-up.
ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus SOC for initial treatment of adult patients with R/R LBCL within 12 months of first-line therapy. In the study, 359 patients in 77 centers around the world were randomized (1:1) to receive a single infusion of Yescarta or historical SOC second-line treatment.
The landmark trial has demonstrated event-free survival (EFS), the primary endpoint, that is superior to historical SOC treatment. This data led to the US approval for initial treatment of R/R LBCL in April 2022 and European Union approval in October 2022. This was followed by approvals in other countries such as Great Britain, Israel, Japan and Switzerland.
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
https://www.europeanpharmaceuticalreview.com/news/180811/kite-releases-pivotal-car-t-therapy-phase-iii-study-results/
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