CAR T-Cell Therapy Starts to Enter MCL Space
Relapsed/refractory mantle cell lymphoma (MCL) is an aggressive disease that could benefit from the addition of chimeric antigen receptor (CAR) T-cell therapy. The ongoing ZUMA-2 trial is investigating the use of the anti-CD19 CAR T-cell product axicabtagene ciloleucel (axi-cel; Yescarta) in patients with relapsed/refractory MCL (NCT02601313).
Relapsed/refractory mantle cell lymphoma (MCL) is an aggressive disease that could benefit from the addition of chimeric antigen receptor (CAR) T-cell therapy. The ongoing ZUMA-2 trial is investigating the use of the anti-CD19 CAR T-cell product axicabtagene ciloleucel (axi-cel; Yescarta) in patients with relapsed/refractory MCL (NCT02601313).
The primary endpoint of this study is to evaluate the safety and efficacy of axi-cel as measured by overall response rate (ORR), with secondary endpoints including duration of response, best objective response, and progression-free survival. Patients enrolled on this trial must have had prior therapy with an anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and either ibrutinib (Imbruvica) or acalabrutinib (Calquence). The trial is estimated to have a primary completion date of July 2018.
Axi-cel has been FDA approved for patients with non-Hodgkin lymphoma (NHL) based on the overall objective response rate from the phase II portion of the ZUMA-1 study. The approval was specifically for patients with large B-cell lymphoma following 2 prior therapies, including diffuse large B-cell lymphoma (DLBCL). In the ZUMA-1 trial, axi-cel demonstrated an ORR of 82% and a CR rate of 54%. After 8.7 months of follow-up, 39% of patients remained in CR. The median duration of response in those with a CR was not reached at the time of the assessment (95% CI, 8.1-not estimable).
In an interview with OncLive, Frederick L. Locke, MD, a medical oncologist at Moffitt Cancer Center, and an investigator on ZUMA-2 and the co-lead investigator on ZUMA-1, discussed the ongoing ZUMA-2 trial investigating axi-cel for patients with MCL.
Reference: https://www.onclive.com/web-exclusives/car-tcell-therapy-starts-to-enter-mcl-space
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