-- Treatment Sequencing Post Hoc Analysis of Outcomes in Patients Treated with Any Cellular Immunotherapy (Including Yescarta in Third-Line) Further Support Previously Reported ZUMA-7 Study Data Showing Benefit of Earlier, Second-Line Treatment with Yescarta --

-- Additional Analysis Reports Improved Outcomes with Yescarta Versus Standard of Care Across Both High and Low Levels of Metabolic Tumor Burden --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two new analyses of the landmark ZUMA-7 trial of Yescarta® (axicabtagene ciloleucel), 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.

“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.”

Abstract #659

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%]. Among Yescarta patients who received 3L cellular immunotherapy (n=8), median PFS was 3.5 months (95% CI, 1.1-not evaluable), and six patients went on to receive subsequent stem cell transplant, with all six alive at data cutoff (median follow-up since 3L treatment initiation: 24.4 months). Of the patients who received retreatment with CAR T-cell therapy in 3L, but did not progress on to stem cell transplant (n=2), one had fatal disease progression at 8.7 months following retreatment, and one had a complete response (CR) and was alive at data cutoff (8.4 months following retreatment). Thirty-four of these patients received 3L chemotherapy following initial response to 2L Yescarta. Among those patients, overall median PFS was 1.7 months (95% CI, 1.4-2.4) and median OS was 8.1 months (95% CI, 6.8-11.9), with an ORR of 32% (CR rate: 18%). Among patients randomized to SOC who received 3L cellular immunotherapy (n=68), median PFS was 6.3 months (95% CI, 3.4-16.3) and median OS was 16.3 months (95% CI, 8.7-not evaluable).

“These findings showed that patients who received CAR T-cell therapy as second-line treatment for r/r LBCL do better than those who wait and receive it as third-line,” said Armin Ghobadi, MD, ZUMA-7 investigator and Associate Professor of Medicine, Division of Medical Oncology, Washington University School of Medicine, St. Louis, Missouri. “These findings support the earlier use of CAR T, and can help inform subsequent treatment choices after second-line treatment, including stem cell transplant.”

Abstract #259

Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7

In an analysis from ZUMA-7 of the association of metabolic tumor volume (MTV) and clinical outcomes, event-free survival (EFS) was superior for Yescarta compared to SOC for patients with high and low MTV (HR, 0.417 and 0.423, respectively; descriptive P