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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Kite’s Yescarta continues to show clinical benefit 2 years post-treatment

Kite, a Gilead company, has provided 2-year follow-up data on Yescarta, the first CAR-T cell therapy approved by the US Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Findings from the study were presented at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Yescarta® (axicabtagene ciloleucel) is a CAR-T cell therapy designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. It was tested in adult patients with relapsed or refractory large B-cell lymphoma in the ZUMO-1 trial.

The latest analysis included results from:
a) a two-year sub-population analysis of efficacy and safety in ZUMA-1 patients by age;
b) preliminary data from a separate safety management study of patients who received early steroid intervention for cytokine release syndrome (CRS) and neurologic events.

Dr John McHutchison, CSO and Head of Research and Development at Gilead Sciences commented: “Longer-term data from ZUMA-1 have shown more than half of patients were still alive two years after treatment with Yescarta. We are committed to further defining the clinical profile of Yescarta, including evaluation of new safety management protocols to further enhance patient care and help move the cell therapy field forward.”

Patients treated with Yescarta were categorized into two groups: those 65 years or older (≥65) (n=24) and those younger than 65 years (<65) (n=77). With a median follow-up of 27.1 months, in the ≥65 group, the objective response rate (ORR) and complete response were 92% and 75% respectively. In the <65 group, they were 81% and 53% respectively.

Among all patients in the safety analysis (27 patients ≥65 and 81 patients <65), most (98%) experienced Grade ≥3 adverse events. Grade ≥3 neurologic events occurred in 12 patients ≥65 (44%) and in 23 patients <65 (28%). Grade ≥3 CRS occurred in 2 patients ≥65 (7%) and in 10 patients <65 (12%).

Additional studies are also being conducted by Kite to further evaluate the efficacy and safety profile of Yescarta. This includes clinical trials to evaluate the use of bridging chemotherapy and other combination approaches.

In a ZUMA-1 safety management study, patients treated with Yescarta is receiving steroid intervention at grade 1 stage of CRS/neurotoxicity to see if administering steroids earlier could reduce the severity of CRS and neurotoxicities associated with the therapy.

21 patients received Yescarta thus far in the study and data showed that 76 percent of patients received corticosteroids and 86 percent received tocilizumab. At a median follow-up of 7.7 months, 33% of patients experienced Grade ≥3 decreased neutrophil 24% showed anemia. Grade 1 or 2 neurologic events and CRS occurred in 48 percent and 100 percent of patients, respectively. No patients experienced Grade ≥3 CRS, and Grade ≥3 neurologic events occurred in only 10 percent of patients. This was lower than in the registrational cohorts of ZUMA-1, implying that earlier intervention to manage side effects could be a possibility to reduce their severity.

Dr Max S. Topp, Lead investigator and Professor and Head of Hematology, University Hospital of Wuerzburg, Germany commented: “Preliminary results of the ZUMA-1 expansion cohort suggest early steroid interventions may reduce the incidence of severe CRS and neurologic events associated with Yescarta without impacting the high response rates to Yescarta therapy in relapsed or refractory large B-cell lymphoma. While longer follow-up in a greater number of patients is required, response rates thus far have been comparable to the pivotal ZUMA-1 study cohorts and rates of Grade 3 or higher CRS and neurologic events have been lower in this preliminary analysis, suggesting that early adverse event management with steroids may further improve the benefit/risk profile of CAR T therapy.”

Source: Kite Announces New Yescarta® Data From ZUMA-1; Press Release

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