Currently Enrolling Trials
Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy.
Tecartus is specifically indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Tecartus is supplied as a suspension for intravenous administration, for autologous use only. Do NOT use a leukodepleting filter. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of Tecartus. Verify the patient’s identity prior to infusion. Premedicate with acetaminophen and diphenhydramine. Confirm availability of tocilizumab prior to infusion. Dosing of Tecartus is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The Tecartus dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.
The FDA approval of Tecartus for mantle cell lymphoma was granted under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Accelerated approval was based on results of ZUMA-2, a single-arm, open-label study which enrolled 74 adult patients with relapsed or refractory MCL. All patients had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The primary endpoint was objective response rate (ORR) per the Lugano Classification (2014), defined as the combined rate of CR and partial responses as assessed by an Independent Radiologic Review Committee (IRRC). In the study, 87% of patients (n=60 evaluable for efficacy analysis) responded to a single infusion of Tecartus, including 62% of patients who achieved a CR. Among all patients, follow-up was at least six months after their first objective disease response. Median duration of response has not yet been reached.
Adverse effects associated with the use of Tecartus may include, but are not limited to, the following:
- infection – pathogen unspecified
- musculoskeletal pain
- motor dysfunction
- decreased appetite
- pleural effusion
The Tecartus drug label comes with the following Black Box Warning:
Cytokine Release Syndrome (CRS), including life threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids, as needed. Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.
Mechanism of Action
Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. Tecartus binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19- expressing cells.
For additional information regarding Tecartus or mantle cell lymphoma, please visit the Tecartus website.