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The regulatory approval corresponds with positive safety and efficacy data from the FELIX trial.
The FDA has granted regulatory approval to obecabtagene autoleucel (Aucatzyl; Autolus Inc), a CD19-directed genetically modified autologous T cell immunotherapy, to treat adults with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL), according to a news release from the agency.1
Acute lymphoblastic leukemia can be managed with forms of chimeric antigen receptor T-cell therapy. | Image Credit: © jarun011 | stock.adobe.com
Obecabtagene autoleucel was evaluated in the FELIX trial (NCT04404660), an open-label, multicenter, single-arm study that enrolled adult patients with R/R CD19-positive B-cell ALL. Patients enrolled were required to have relapsed following a remission lasting 12 months or less, R/R ALL following 2 or more lines of systemic therapy, or disease that was R/R 3 or more months following allogenic stem cell transplantation.1,2
Primarily, the investigators sought to evaluate the drug’s safety and efficacy by determining the rate and duration of complete remission (CR) achieved within 3 months following infusion, in addition to rate and duration of overall CR. Patients went through 5 stages in the trial: screening, leukapheresis, pre-conditioning, treatment, and follow-up.2
In total, 65 patients were evaluable for efficacy. Of these, 27 (42%; 95% CI, 29%-54%) achieved CR within 3 months, according to the study data. Furthermore, the median duration of CR achieved within 3 months was 14.1 months (95% CI, 6.1-not reached).1
Safety data were also deemed positive for the drug. A pre-specified interim analysis of the trial, presented at the 2023 American Society of Clinical Oncology Annual Meeting, was conducted based on a total of 92 participants. Of these patients, 63% developed any-grade cytokine release syndrome (CRS), at a median of 9 days post-infusion and a median duration of 5 days. Additionally, any grade immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in 23% of patients.3
Trial Name: A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
ClinicalTrials.gov ID: NCT04404660
Sponsor: Autolus Limited
Estimated Completion Date: May 2025
More detailed safety data were released by the FDA, with the agency noting that the prescribing information for obecabtagene autoleucel contains a boxed warning for CRS, ICANS, and T-cell malignancies. In the full study population, CRS occurred in 75% of participants, with neurological toxicities occurring in. 64%, including ICANS in 24%.1
Common non-laboratory adverse reactions—with an incidence of ≥ 20%--included CRS, pathogen-unspecified musculoskeletal pain, viral infections, nausea, fever, diarrhea, febrile neutropenia, ICANS, and headache, among others. In the interim analysis, febrile neutropenia was also observed, at a rate of 25%, in addition to anemia (20%).1,3
In their announcement, the FDA wrote that the recommended dose of obecabtagene autoleucel is 410 X 106 CD19 chimeric antigen receptor (CAR)-positive viable T cells to be administered as split dose infusion on Day 1 and Day 10. The dose should be based on bone marrow blast assessment and follow fludarabine and cyclophosphamide lymphodepleting chemotherapy.1
