Posted: Friday, March 17, 2023
New real-world outcomes data about patients with relapsed or refractory mantle cell lymphoma indicate that both the efficacy and toxicity of brexucabtagene autoleucel are consistent with those of ZUMA-2, the single-arm phase II trial upon which the agent’s U.S. Food and Drug Administration approval was based. Brexucabtagene autoleucel, an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy, was infused into 168 of 189 patients who underwent leukapheresis in 2020 and 2021 in 1 of the 16 U.S. Lymphoma CAR T Consortium centers, wrote Michael D. Jain, MD, PhD, of Moffitt Cancer Center, Tampa, Florida, and colleagues in the Journal of Clinical Oncology.
“The best overall and complete response rates were 90% and 82%, respectively,” the team stated, compared with 91% and 68% in the ZUMA-2 population. Of note, of the 168 patients. who underwent leukapheresis, 65% would have been ineligible for ZUMA-2 because of disease status or comorbidities, and another 14% would have been ineligible solely because they had never received a Bruton’s tyrosine kinase (BTK) inhibitor and/or anthracycline/bendamustine. “Our study provides a critical first set of data of [brexucabtagene autoleucel] efficacy in BTK inhibitor–naive patients,” they pointed out, with high overall response (96%), complete response (88%), 12-month progression-free survival (69%), and 12-month overall survival (87%) rates.
The study’s overall response rate was comparable with that of ZUMA-2—90% versus 91%—but the complete response rate appeared to be higher, possibly because of bridging therapy and better disease control before brexucabtagene autoleucel infusion. However, patients who had been exposed to bendamustine within 24 months of leukapheresis had relatively shorter progression-free and overall survival after leukapheresis, explained Dr. Jain and co-investigators. Tumor-intrinsic features of mantle cell lymphoma may be associated with inferior efficacy outcomes, they added.
“Prospective trials are needed, particularly in high-risk groups, to determine the optimal sequencing of therapy options,” the team concluded.
Disclosure: The study authors’ disclosure information can be found at ascopubs.org.