The US Food and Drug Administration (FDA) has approved Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
MCL is a rare form of malignant non-Hodgkin lymphoma affecting B lymphocytes in the lymph nodes within a region called the “mantle zone”. Early symptoms include fever, involuntary weight loss, and night sweats.
Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell therapy. It was originally given accelerated approval in 2020 for R/R MCL. The full approval, given as a result of showing its clinical benefit, is based on data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve.
ZUMA-2 is a single-arm, open-label, multicenter study evaluating brexucabtagene autoleucel in adult patients with R/R MCL. Cohorts 1 and 2 evaluated patients who had previously received up to five lines of therapy including anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a BTKi. Cohort 3 evaluated patients who had received up to five prior lines of therapy and were BTKi-naïve. A total of 82 patients were treated in Cohorts 1 and 2, and 86 patients were treated in Cohort 3. The primary endpoint across the study was objective response rate (ORR) per the Lugano Classification (2014).
Safety data was pooled across Cohorts 1–3. Cytokine release syndrome occurred in 93% of patients, including Grade 3 or greater cytokine release syndrome in 12%. The median time to onset was 4 days and the median duration was 7 days. Neurologic events occurred in 80% of patients, including Grade 3 or greater neurologic events in 33%. The median time to onset was 6 days and the median duration was 19 days. Infections of any grade occurred in 63% of patients, including Grade 3 or greater infections in 33%.
In Cohort 3, serious adverse reactions occurred in 65% of patients. The most common serious adverse reactions were non-ventricular arrhythmias, tachycardias, pyrexia, cytokine release syndrome, unspecified pathogen infections, viral infections, bacterial infections, fungal infections, musculoskeletal pain, motor dysfunction, encephalopathy, aphasia, tremor, seizure, delirium, hypoxia, hypotension, hemorrhage, and thrombosis.
Brexucabtagene autoleucel contains a Boxed Warning for cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies.
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To learn more about MCL and other rare cancers, visit https://checkrare.com/diseases/cancers/