Obecabtagene autoleucel, sold under the brand name Aucatzyl, is an anti-cancer medication used for the treatment of acute lymphoblastic leukemia.
It is a CD19-directed genetically modified autologous T-cell immunotherapy.
It is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.[
The most common side effects include cytokine release syndrome, infections-pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, immune effector cell-associated neurotoxicity syndrome, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.
It has a boxed warning for cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and T-cell malignancies.
Efficacy was evaluated in FELIX an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
Enrolled participants were required to have relapsed following a remission lasting twelve months or less, relapsed or refractory acute lymphoblastic leukemia following two or more prior lines of systemic therapy, or disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation.
The major efficacy outcome measures were rate and duration of complete remission achieved within three 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, at any time.
Of the 65 participants evaluable for efficacy, 27 participants (42%) achieved complete remission within three months.
The median duration of complete remission achieved within three months was 14.1 months (95% CI: 6.1, not reached).
Obe-cel CAR treatment resulted in a high incidence of durable response among patients with relapsed or refractory B-cell ALL with a low incidence of grade 3 or higher immune related toxic effects.