Phase 3 Trial to Test Yescarta as Second-line Therapy for DLBCL Patients

Phase 3 Trial to Test Yescarta as Second-line Therapy for DLBCL Patients

Kite Pharma has opened a new Phase 3 clinical trial to investigate the effectiveness of Yescarta (axicabtagene ciloleucel) as a second-line therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who failed prior chemotherapy.

Details about the trial, which is enrolling participants, were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5 in Chicago, Illinois. The poster was titled, “ZUMA-7: A phase 3 randomized trial of axicabtagene ciloleucel (Axi-Cel) versus standard-of-care (SOC) therapy in patients with relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL).”

The presentation was made June 4 in the session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.

Yescarta is a kind of cell therapy that harvests and genetically modifies a patient’s own T-cells to recognize and destroy cancer cells. Because cells produce an engineered chimeric antigen receptor (CAR), the approach in known as CAR T-cell therapy.

In October 2017, the U.S. Food and Drug Administration (FDA) approved Yescarta as a therapy for patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL) who had failed at least two prior therapeutic approaches.

Yescarta’s indications include diffuse DLBCL, the most common type of non-Hodgkin lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and transformed follicular lymphoma (TFL).

The approval was supported by results from ZUMA-1 (NCT02348216), a Phase 1/2 trial that assessed Yescarta in DLBCL, PMBCL, or TFL patients, most of whom had advanced-stage disease.

In the trial, 72 percent of patients who received a single injection of Yescarta responded to the treatment, and 51 percent had complete tumor elimination. After a median follow-up of 7.9 months, more than half of patients with complete responses were still disease-free.

Also, more than one year after Yescarta treatment, 42 percent of patients were still responding.

The new Phase 3 trial — ZUMA-7 (NCT03391466) — will determine if Yescarta is better than standard of care as a second-line treatment for DLBCL patients who relapsed or are refractory to first-line chemotherapy with Rituxan (rituximab) and anthracycline.

The open-label, multi-center study is looking to recruit 350 participants. Enrolment is now open in 13 centers across the U.S.

Participants will be assigned randomly either Yescarta or standard treatment, which consists of a platinum-based salvage chemotherapy regimen, followed by high-dose chemotherapy and a stem cell transplant for those eligible.

The trial’s primary objective is event-free survival, defined as the time from randomization to disease progression, start of a new lymphoma therapy, or death.

Additional (secondary) goals of the study include objective response rate, time to disease progression or death, duration of response, overall survival, safety, and patient-reported outcomes.

More information on how to enroll is available here.