Approval of First CAR T-Cell Therapy for Relapsed/Refractory MCL to Change How Patients are Treated 'Forever and for the Better'

The Food and Drug Administration’s (FDA) recent approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) will forever change the way the disease is treated, according to Dr. Michael Wang.

“The FDA approval of (Tecartus) will change the way we treat patients with relapsed MCL forever and for the better,” Wang, a professor in the department of lymphoma and myeloma at The University of Texas MD Anderson Cancer Center, said in an interview with CURE®’s sister publication, OncLive®.

With this approval, Tecartus became the first and only approved chimeric antigen receptor (CAR) T-cell therapy in this patient population.

The agency based its decision on data from the single-arm, open-label ZUMA-2 trial, which showed that 87% of patients responded to a single infusion of the CAR T-cell therapy. Sixty-two percent of those patients achieved a complete response after the infusion.

“In this study, patients had received three prior therapies, so (Tecartus) was the fourth therapy patients received,” said Wang, who is also the lead investigator for the ZUMA-2 trial. “In the fourth-line setting, generally the response rate is about 20% to 25%. With the CD19-directed CAR T-cell therapy, the response rate is 87%, and the (complete response) rate is 62%.”

Side Effect Profile

Among patients evaluable for safety, 18% experienced a serious or severe side effect of cytokine release syndrome (CRS) and 37% experienced serious or severe neurologic toxicities.

CRS and neurotoxicity were very well managed among the patient population in the ZUMA-2 trial, according to Wang, however, he did note that one patient died from CRS.

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