THE PRODUCT — Aucatzyl is an individualized cellular product prepared from the patient’s own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The T cells are sent to a commercial laboratory, which genetically modifies them using a lentiviral vector to encode an anti-CD19 CAR transgene. Aucatzyl is supplied in 3 to 5 patient-specific infusion bags.

CLINICAL STUDIES — In a single-arm trial (FELIX) that included 94 patients with relapsed or refractory B-cell ALL with morphologic disease, after a median follow-up of 20.3 months, overall remission was achieved in 77% of patients, complete remission in 55%, and complete remission with incomplete hematologic recovery in 21% who received obecabtagene autoleucel. The median duration of response was 14.1 months.3

No trials directly comparing Aucatzyl with Kymriah or Tecartus for treatment of relapsed or refractory B-cell precursor ALL are available.

ADVERSE EFFECTS — Aucatzyl can cause prolonged cytopenias, severe and fatal infections, hypogammaglobulinemia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. The label includes a boxed warning about the risks of immune effector cell-associated neurotoxicity syndrome (ICANS), T cell malignancies, and cytokine release syndrome (CRS), a common complication of CAR T-cell immunotherapy that can cause hypotension, pulmonary edema, coagulopathy, multiorgan failure and death, associated with its use. In the FELIX trial, CRS occurred in about 70% of patients and neurologic toxicity occurred in about 23%. Grade 3 or higher CRS occurred in about 2% of patients. Unlike Kymriah and Tecartus, which are available only through a Risk Evaluation Mitigation Strategy (REMS) program due to risks of CRS and neurologic toxicity, a REMS program is not required with Aucatzyl.

DOSAGE, ADMINISTRATION, AND COST — Cyclophosphamide and fludarabine lymphodepleting chemotherapy should be administered before infusion of 410 x 10⁶ CD19 CAR-positive viable T cells. The CAR T cells are given as a split dose infusion on days 1 and 10. Acetaminophen should be administered about 30 minutes before infusion of Aucatzyl. Patients should be monitored at the treatment facility for at least 2 weeks after the infusion and should stay near the treatment facility for at least 4 weeks.

The wholesale acquistion cost (WAC) of Aucatzyl is $525,000. Tecartus costs $462,000 and Kymriah costs $582,000.4