Dr Goy on Outcomes From An Expanded Access Study of Brexu-Cel in Relapsed/Refractory MCL

Andre Goy, MD, physician in chief, Hackensack Meridian Health Oncology Care Transformation Services, chairman, chief physician officer, chief, Lymphoma Division, John Theurer Cancer Center, Hackensack University Medical Center, discusses outcomes with brexucabtagene autoleucel (brexu-cel; Tecartus) in patients with relapsed/refractory mantle cell lymphoma (MCL) enrolled in the phase 2 ZUMA-2 trial (NCT02601313) and the expanded access ZUMA-18 (NCT04162756) study.

In July of 2020, the FDA granted approval to the CAR T-cell therapybrexu-cel for adult patients with relapsed/refractory MCL; this regulatory decision was based on findings from ZUMA-2.

After a median follow-up of 4 years, brexu-cel demonstrated sustained survival benefits in the ZUMA-2 study population. The agent produced a median overall survival (OS) of 58.7 months among patients who achieved a complete response (CR).

Brexu-cel continued to show encouraging activity in patients with relapsed/refractory MCL in the expanded access study, ZUMA-18. Between July 2019 and July 2020, responses in 23 patients with amedian age of 69 years (range, 43-79) were assessed. Notably, this is higher than the median age of 65 years in ZUMA-2, Goy began. ZUMA-18 also consisted of patients with a higher ECOG performance status who had received a greater median number of prior therapies, he explains. Overall, this cohort was characterized by advanced age, compromised health status, and increased pretreatment, Goy notes.

In ZUMA-18, brexu-cel elicited an objective response rate of 87%, including a CR rate of 57% (95% CI, 34.5-76.8). The median duration of response was 15.1 months in responders and 20.0 months in patients achieving a CR. After approximately 3 years of follow-up, the median OS had not been reached (95% CI, 10.4-not evaluable), Goy states, adding that no new safety concerns emerged.

Cytokine release syndrome (CRS) was proactively managed, resulting in 4% of patients experiencing grade 3 CRS events, he continues. Although some neurotoxicity was observed, none reached grade 5 severity. Among the 5 reported patient deaths, 1 involved multi-organ failure with candidemia occurring on day 4 post-treatment initiation, Goy says.

Collectively, these findings support the ongoing utilization of brexu-cel in relapsed/refractory MCL, Goy concludes.