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Brexucabtagene Autoleucel ZUMA-2 and ZUMA-18, Expanded Access Study [ASH 2023]

In the realm of advancements in CAR T-cell therapy for relapsed/refractory mantle cell lymphoma (MCL), Dr. Brian Hill, MD, PhD, stands at the forefront to discuss the findings of the ZUMA-2 and ZUMA-18 studies.

The ZUMA-2 study reported a median overall survival (OS) of 46.4 months with brexu-cel, showcasing its efficacy in patients with relapsed/refractory MCL and a complete response (CR). Dr. Hill will explore the implications of these findings, contributing to the evolving landscape of CAR T-cell therapy for MCL. Moreover, he will discuss considerations surrounding the durability of response observed in these patients, adding a dimension to the understanding of long-term treatment outcomes.

Moving to the ZUMA-18 study, Dr. Hill will discuss the efficacy results for brexu-cel, including an 87% objective response rate (ORR) and a median OS not yet reached at 33.5 months of follow-up. He will talk about the significance of these results, particularly in the context of providing brexu-cel access to patients before commercial availability and for those whose manufactured product does not meet commercial release specifications. This aspect holds importance in ensuring timely and effective treatment options for a broader patient population.

Safety considerations in CAR T-cell therapy are paramount, and Dr. Hill will discuss the combined analysis of ZUMA-2 and ZUMA-18, which reported Grade 5 adverse events, some unrelated to brexu-cel therapy. He will provide insight into interpreting these safety findings, emphasizing their implications for long-term outcomes and the potential broader application of brexu-cel in relapsed/refractory MCL.

The discussion will extend to the study reporting subsequent malignancies in a subset of patients treated with axi-cel. Dr. Hill will address the diverse types of subsequent malignancies observed and elucidate how these findings should influence the long-term monitoring and management of patients who have undergone axi-cel therapy, bringing a comprehensive perspective to the broader implications of CAR T-cell therapies in the oncology landscape.

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