FDA

CAR-T cell therapy approved for B-cell ALL

November 12, 2024

Brand name: Aucatzyl

Generic name: obecabtagene autoleucel (obe-cel)

Manufacturer: Autolus Therapeutics

Approval date: November 8, 2024

Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T cell immunotherapy, is indicated for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

Efficacy

Efficacy was evaluated in the open-label, multicenter, single-arm FELIX trial (NCT04404660) that enrolled adults with CD19-positive r/r B-ALL. Participants were required to have relapsed following a remission lasting ≤12 months, relapsed or refractory ALL following ≥2 prior lines of systemic therapy, or disease that was relapsed or refractory ≥3 months after allogeneic stem cell transplantation.

The major efficacy outcome measures were rate and duration of complete remission (CR) achieved within 3 months after infusion. Additional outcome measures were rate and duration of overall complete remission which includes complete remission and complete remission with incomplete hematologic recovery (CRi), at any time. Of 65 patients evaluable for efficacy, 27 patients (42%) achieved CR within 3 months. Median duration of CR achieved within 3 months was 14.1 months.

Safety

The prescribing information has a boxed warning for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and T cell malignancies. CRS occurred in 75% (Grade 3, 3%) and neurologic toxicities occurred in 64% (Grade ≥3, 12%), including ICANS in 24% (Grade ≥3, 7%).

The most common non-lab adverse reactions (incidence ≥ 20%) included CRS, infections-pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.

Recommended dose

The total recommended dose of obe-cel is 410 X 10^6 CD19 chimeric antigen receptor (CAR)-positive viable T cells to be given as split dose infusion on day 1 and day 10 (±2 days) based on bone marrow blast assessment and preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy.

Source:

FDA. (2024, November 8). FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. [Press release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute

Autolus Therapeutics. (2024, November 8). Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). [Press release]. https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-announces-fda-approval-aucatzylr