Dr Goy on Updated Data From ZUMA-2 With Brexu-Cel in MCL


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Andre Goy, MD, discusses updated data from the phase 2 ZUMA-2 trial, highlighting the expanded-access ZUMA-18 study in MCL.

Andre Goy, MD, vice president, physician in chief, Oncology, Hackensack Meridian Health Oncology Care Transformation Services, chairman, chief physician officer, Lydia Pfund Chair for Lymphoma, Lymphoma Division, John Theurer Cancer Center, Hackensack University Medical Center, academic chairman, Oncology, Hackensack Meridian School of Medicine; professor, medicine, Georgetown University, discusses updated data from the phase 2 ZUMA-2 trial (NCT02601313), highlighting the expanded-access ZUMA-18 study (NCT04162756) evaluating brexucabtagene autoleucel (brexu-cel; Tecartus) in patients with relapsed/refractory mantle cell lymphoma (MCL).

Notably, in July 2020, the FDA granted approval to brexu-cel for adult patients with relapsed/refractory MCL based on findings from ZUMA-2. During the 2023 ASH Annual Meeting, updated long-term follow-up data from the ZUMA-2 trial were discussed, Goy begins. At the 4-year mark, the median overall survival (OS) for patients achieving a complete response (CR) stood at 58.7 months, he reports. This achievement is notable, particularly considering that the ZUMA-2 trial enrolled patients who had previously progressed on chemotherapy, an anti-CD20 agent, and a BTK inhibitor, treatments for which the median OS was traditionally measured in months rather than years, Goy explains.

Moreover, the implications of the outcomes observed in the ZUMA-2 and ZUMA-18 trials could significantly influence the clinical treatment of patients with relapsed/refractory MCL, Goy expands. Conducting expanded-access trials holds significance as these trials often cater to patients who have exhausted all other treatment options, he emphasizes. Despite the ZUMA-18 trial population being characterized by greater illness severity, advanced age, and more extensive prior treatments compared with the ZUMA-2 population, notable response rates were still observed. Although the reported CR rate with brexu-cel in ZUMA-18 stood at 57%, it's worth noting that the criteria for enrollment in expanded-access trials are less stringent compared with those of standard trials, Goy reports.

Consequently, several patients did not undergo repeat bone marrow biopsies, potentially leading to an underestimation of CR rates, he states. Moreover, although brexu-cel may exhibit less durability in the expanded-access population than in the ZUMA-2 population, the impressive median OS achieved with brexu-cel in ZUMA-18 compared favorably with alternative treatment options available in similar settings. To maximize the benefits of CAR T-cell therapy, early referral of patients is recommended, Goy concludes.

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