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Caron Jacobson, MD, discusses the design of the phase 2 ZUMA-5 trial in patients with relapsed/refractory indolent non-Hodgkin lymphoma.
Caron Jacobson, MD, medical director of the Immune Effector Cell Therapy Program; a physician at Dana-Farber Cancer Institute; and an assistant professor of medicine at Harvard Medical School, discusses the design of the phase 2 ZUMA-5 trial in patients with relapsed/refractory indolent non-Hodgkin lymphoma.
The ZUMA-5 trial is an open-label, clinical trial that treated every patient with the same therapy, which was axicabtagene ciloleucel (axi-cel; Yescarta), says Jacobson. This study included 2 subtypes of patients with relapsed/refractory indolent B-cell NHL: follicular lymphoma and marginal zone lymphoma (MZL). The planned accrual for the trial was 125 patients with follicular lymphoma and 35 patients with MZL.
The data presented during the 2020 ASCO Virtual Scientific Program was on all patients with follicular lymphoma, as well as 16 patients with MZL. All of these patients were in the third-line treatment setting or beyond. Prior treatments included chemoimmunotherapy with a CD20 antibody and an alkylating agent. Patients had a median of 3 prior lines of therapy; most patients received the study treatment as their fourth line of treatment, says Jacobson. Approximately 70% of the patient population had 3 or more prior lines of therapy. Thus, ZUMA-5 included a heavily pretreated, high-risk patient population. Most patients had a high tumor bulk per GELF criteria and a high-risk FLIPI score. Additionally, half of all patients enrolled had progressed after first-line therapy within the first 2 years, concludes Jacobson.