Lymphoma

Brexucabtagene autoleucel (brexu-cel; Tecartus), the first FDA-approved chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory mantle cell ...

This was very similar to the ZUMA-2 trial, in which 91% of patients had CRS, 15% of which was grade 3/4, and 63% of whom had neurologic events, 31% of which was grade 3/4. Lastly, these data were the first to show efficacy with brexu-cel in patients who were naive to BTK inhibitors. Median overall survival (OS) was not reached (95% CI, 18.7-NE), with 6-month OS rate of 86% (95% CI, 79%-90%) and 12-month OS rate of 75% (95% CI, 67%-81%). Patients who received BTK inhibitors also did not have a statistically significant difference in PFS from those who were naive to BTK inhibitors. No difference was seen in PFS based on worse performance status or being treatment-naive to bendamustine/anthracycline, but patients who would have been excluded from ZUMA-2 due to disease status or comorbidities did have a worse OS. Investigators observed that a 41% of patients who had received bendamustine within 6 months of leukapheresis did not receive brexu-cel, including 13% who had manufacturing failure. Patients with CNS involvement, who would have been excluded from ZUMA-2, did not appear to have worse PFS than the overall population. At a median follow-up of 14.3 months (95% CI, 12.7-15.9), the median DOR was 17.2 months (95% CI, 14.4-not estimable [NE]). In 95 who were assessed for a response, there was an ORR to bridging therapies of 33%, including 6% with a CR. Those with disease progression within 24 months of primary therapy also had a shorter PFS than overall, but it was not a statistically significant difference. Multiple high-risk disease features were associated with poor progression-free survival (PFS), as was prior exposure to bendamustine (Bendeka). Some of these were due to the ZUMA-2 trial requiring patients not receive prior therapies including anthracycline, bendamustine, or a Bruton tyrosine kinase inhibitor.