Lori Leslie, MD, describes the cohorts of the phase 2 ZUMA-2 study and discusses the potential impact of brexucabtagene autoleucel in the mantle cell lymphoma landscape.
Lori Leslie, MD, assistant professor, Hackensack Meridian School of Medicine, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, describes the cohorts of the phase 2 ZUMA-2 study and discusses the potential impact of brexucabtagene autoleucel (Brexu-cel;Tecartus) in the mantle cell lymphoma (MCL) landscape.
ZUMA-2 is a multicenter study (NCT02601313) evaluating the safety and efficacy of brexu-cel in patients with relapsed or refractory MCL. The FDA granted accelerated approval for of brexu-cel based on early ZUMA-2 results. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial.
Leslie explains that results from the Bruton’s tyrosine kinase inhibitor-naïve population will provide more evidence to support the use of brexu-cel in patient with relapsed or refractory MCL. Moreover, there are other clinical trials looking at the real-world MCL population.
Research also hints that there is potential to move chimeric antigen receptor (CAR) T-cell therapy into earlier lines in patients with B-cell lymphomas, explains Leslie.
0:08 | There are a few different cohorts ongoing in ZUMA-2 looking at brexucabtagene. We've got a cohort looking at BTK-naive patients, we have a cohort that's expanded access that allows bridging therapies and more of our real-world population, and then there's a cohort where you can get access to cells if they're out of specification.
0:28 | I think these data along with data that's emerging from real world experience with brexucabtagene in mantle cell lymphoma, show us that what we see in clinical trials is translating to our real-world population. I'm hoping these data will help convert the accelerated approval into a full, long term FDA approval for this CAR T-cell product in patients with relapsed mantle cells. I think moving forward too, it will be investigated in earlier lines of therapy as we're doing with other CD19 CAR T-cell products across B-cell lymphomas.
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