Gilead's Kite Reports Positive Trial Results Of T-cell Therapy Yescarta In R/R Large B-cell Lymphoma

Kite, the cell therapy unit of Gilead Co. (GILD), announced Monday positive results from the Phase 2 ALYCANTE study for use of its chimeric antigen receptor or CAR T-cell therapy Yescarta (axicabtagene ciloleucel) in patients with relapsed/refractory or R/R large B-cell lymphoma.

In the trial, led and sponsored by the French collaborative group LYSA/LYSARC, Yescarta demonstrated high response rate and durable remission as initial treatment for transplant ineligible patients with R/R Large B-cell Lymphoma.

The trail was for use of Yescarta in patients with R/R large B-cell lymphoma or LBCL after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).

The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT.

The study was funded by Kite, and carried out with axicabtagene ciloleucel CAR T-cell therapy manufactured by Kite.

The study met its primary endpoint, with a complete metabolic response or CMR of 71% at 3 months versus 12% expected with standard of care. At 6 months, 59.7% of patients remained in CMR, which is defined as negative findings on a PET study during or following antitumor therapy.

Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study, said, “Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis. ALYCANTE is the first study to assess axicabtagene ciloleucel as second-line therapy for transplant ineligible R/R LBCL and the results showed high response rates and durable remission in this hard-to-treat population.”

The full findings from the study were published in Nature Medicine.

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