Gilead subsidiary Kite has announced positive long-term data from the ZUMA-1 study of Yescarta (axicabtagene ciloleucel) in adults suffering from refractory large B-cell lymphoma.
The long-term results include new overall survival data from the Phase II trial at three years after a single infusion of Yescarta.
In addition, the company reported data from a safety management cohort, where patients were given early steroid intervention for cytokine release syndrome (CRS) and neurologic events.
A minimum follow-up of three years showed that 47% of participants with refractory large B-cell lymphoma in the Phase II cohorts survived with a median overall survival (OS) of 25.8 months.
During the safety management analysis, relapsed or refractory large B-cell lymphoma patients who received Yescarta were given earlier steroid intervention upon Grade 1 CRS or Grade 1 neurologic event without any improvement following three days of supportive care.
According to Kite, 41 patients in this cohort were administered with Yescarta and had a median follow-up of 8.7 months. Of the participants, 73% received corticosteroids and 76% were given tocilizumab.
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Earlier steroid use was observed to reduce the percentage of patients with Grade ≥3 CRS and neurologic events. The company added that the rates were numerically lower than those found in the trial’s registrational cohorts.
Kite CEO Christi Shaw said: “With approximately half of patients with refractory large B-cell lymphoma in our registrational trial alive three years following treatment with Yescarta, we are delivering towards our goal of potentially life-saving therapy for many patients who previously faced limited treatment options and a poor prognosis prior to the introduction of CAR T therapy.
“These results, coupled with an analysis that suggests a reduced risk of severe CRS and neurological events with earlier use of steroids, further support our ongoing leadership in cell therapy and commitment to patient care.”
Yescarta is a CAR T cell therapy indicated to treat relapsed or refractory large B-cell lymphoma in adults in the US. The drug can be taken following two or more lines of systemic therapy.