Kite, a Gilead Company announced findings from two new analyses of the landmark ZUMA-7 trial of Yescarta, the largest and longest follow-up of a CAR T-cell therapy versus standard of care (SOC) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL). These results include an analysis of outcomes for patients who received subsequent treatment for their lymphoma following second-line Yescarta therapy or SOC therapy, as well as an exploratory analysis of the association between metabolic tumor volume (MTV) and clinical outcomes. The data were presented orally at the 2022 American Society of Hematology (ASH) Annual Meeting & Exposition on December 11 and 10, respectively (Abstracts #659 and #259).
Data from the pivotal ZUMA-7 trial supported the U.S. Food and Drug Administration’s (FDA) expanded approval of Yescarta in April 2022 as initial treatment in adults with r/r LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and led to a similar approval by the European Medicines Agency in October 2022. This year marks Yescarta’s 5th anniversary from the initial approval by the FDA in 2017 as the first CAR T-cell therapy for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.
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“These further analyses from the ZUMA-7 study show consistent benefit of Yescarta versus standard of care in the second-line r/r LBCL setting, including for those who require subsequent third-line treatment and even for specific patient subgroups,” said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. “These results provide physicians additional confidence in utilizing Yescarta as initial treatment of relapsed/refractory large B-cell lymphoma.”
Outcomes of Subsequent Anti-Lymphoma Therapies In Patients With Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel) or Standard of Care (SOC) in the Second-Line (2L) Zuma-7 Study
In an analysis of patients from the ZUMA-7 trial who required subsequent therapy following second-line treatment, 47% (84 of 180) of patients randomized to receive Yescarta in the second-line (2L) required subsequent therapy compared to 71% (127 of 179) patients randomized to 2L standard of care. For patients who received third-line (3L) chemotherapy following treatment with Yescarta (n=60), overall median progression-free survival (PFS) was 1.7 months (95% CI, 1.4-2.0) and median overall survival (OS) was 8.1 months (95% CI, 5.8-11.5) since 3L treatment initiation, with an objective response rate (ORR) of 25% [complete response (CR) rate: 13%].
SOURCE: Businesswire