Yescarta Demonstrates Durable Survival Benefit in Relapsed/Refractory Follicular Lymphoma with 94% Overall Response Rate at 18-Month Follow-Up

Follicular lymphoma (FL, Image source: leukemia-cell.org)

June 15, 2021 News /BioonBIOON/ -- Kite Pharma, a cell therapy company under Gilead (Gilead Sciences), recently announced follow-up results from the pivotal ZUMA-5 trial evaluating the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory follicular lymphoma (FL).Data with a minimum follow-up of 18 months show that 94% of patients achieved a response (ORR = 94%)., median progression-free survival (PFS) and overall survival (OS) for the secondary endpoints have not yet been reached. In a weighted analysis, patients in the ZUMA-5 trial with at least 18 months of follow-up were compared with patients observed in the SCHOLAR-5 trial (an external control cohort),Yescarta demonstrated superior OS and PFS compared to currently available therapies.

Yescarta is the first and only CAR T-cell therapy approved for the treatment of FL.FL is an indolent non-Hodgkin lymphoma (iNHL), in which malignantTumorIt grows slowly but becomes more aggressive over time. FL is the most common indolent lymphoma and the second most common lymphoma type worldwide. FL accounts for approximately 22% of diagnosed lymphoma cases globally. Currently, treatment options are limited for patients with relapsed or refractory indolent FL who have received two or more prior systemic therapies.

Yescarta is a CD19 CAR-T cell therapy acquired by Gilead Sciences through its $11.9 billion acquisition of Kite Pharma. In the United States, Yescarta was in October 2017 approvedFDAApproved, it is the first CAR-T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma (LBLC).

In March 2021, Yescarta received USFDAApproval of a new indication: for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have previously received two or more systemic therapies.

This published propensity score analysis compares follow-up data from the pivotal Phase 2 ZUMA-5 study (n=86) (median follow-up, 23.3 months; at least 80 patients with FL) with a weighted sample (n=80) from the SCHOLAR-5 external control cohort (n=85) receiving current therapies, with patient characteristics balanced using propensity scores.

Analysis data show,In the ZUMA-5 cohort, 94% of patients achieved a response, compared with 50% in the control cohort (median follow-up of 26.2 months)., the odds ratio (OR) was 16.2 (95% CI: 5.6-46.9).Compared with the current therapy received by the control cohort, Yescarta reduced the risk of death by 58%.（HR=0.42；95%CI:0.21-0.83，p=0.01），Reduced the risk of disease progression, relapse, or death by 70% (HR = 0.30; 95% CI: 0.18–0.49, p < 0.001). The median PFS and OS for the ZUMA-5 cohort were not reached, whereas those for the control cohort were 12.7 months and 59.8 months, respectively.

In the ZUMA-5 safety analysis dataset (n=146), the incidence of Grade ≥3 cytokine release syndrome (CRS) and neurologic toxicity was 8% and 21%, respectively.

Medicine, Barts Cancer Research Centre, UKTumorProfessor John Gribben commented: “Follicular lymphoma (FL) is one of the most common non-Hodgkin lymphomas, and patients experience frequent relapses, which quickly leaves clinicians with limited treatment options. The new analysis data from the ZUMA-5 study are highly encouraging, demonstrating that Yescarta provides a significant and durable survival benefit, even in patients who have undergone multiple prior lines of therapy.”

Caron A. Jacobson, Medical Director of the Immune Effector Cell Therapy Program at Dana-Farber Cancer Institute and Assistant Professor at Harvard Medical School, stated: “For indolent diseases such as follicular lymphoma (FL), long-term data demonstrating durable remission are critical. Following relapse in FL patients, each subsequent line of therapy is associated with progressively shorter remission durations. The nearly two-year durable benefit demonstrated with Yescarta is exciting, and the substantial survival benefit observed relative to current therapies in the SCHOLAR-5 analysis is encouraging. These follow-up data reinforce Yescarta as a significant advance for a patient population that previously had very few treatment options.” (Bioon.com)

Original Source:Longer-term Data for Kite’s Yescarta? in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis