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Sub-analyses of Landmark ZUMA-7 Trial Reinforce Yescarta® CAR T-cell Therapy Superiority Over Standard of Care (SOC) as Initial Treatment for Patients With Relapsed or Refractory Large B-cell Lymphoma (LBCL)

Published: 2022-06-04 13:00:00 ET
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-- Patients Aged 65+ Had Over Three-fold Improvement in Two-year Event-Free Survival (EFS) Rate, and Over Eight-fold Greater Median EFS and Clinically Meaningful Improvements in Quality of Life (QoL) with Yescarta vs SOC --

-- Separate Exploratory Analysis Found Yescarta Benefit vs SOC Was Consistent Across Subgroups, Including in Patients with High Tumor Burden and Elevated Lactate Dehydrogenase (LDH) --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two pre-planned, subgroup analyses of the landmark ZUMA-7 trial of Yescarta® (axicabtagene ciloleucel), which led to the U.S. Food and Drug Administration’s (FDA) recent expanded approval of Yescarta as initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. These results include an analysis of clinical and patient-reported outcomes (PROs) in patients aged 65 or older, as well as an exploratory analysis of the association of pre-treatment tumor characteristics with clinical outcomes in patients with both low and high tumor burden and elevated and non-elevated lactate dehydrogenase(LDH). The data were presented today at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstracts #7548 and #7565).

“Patients with large B-cell lymphoma aged 65 and above are at higher risk of not being eligible for or able to tolerate the standard of care, which can lead to poorer outcomes and health-related quality of life,” said Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. “These data demonstrate that older patients, who are frequently considered transplant-ineligible based on age, can safely receive second-line CAR T-cell therapy with curative intent.”

In the ZUMA-7 sub-analysis of patients aged 65 and older, the primary endpoint of event-free survival (EFS) demonstrated that Yescarta (n=51) was superior to SOC (salvage chemoimmunotherapy followed by high-dose chemotherapy and stem cell transplant in those who respond; n=58; Hazard Ratio [HR], 0.276; descriptive P