The Food and Drug Administration (FDA) approved the CAR-T cell therapy Aucatzyl (obecabtagene autoleucel) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-cell ALL), according to an alert from the agency.
The approval was based on findings from the FELIX trial, which assessed Aucatzyl in patients with relapsed or refractory CD19-positive B-cell ALL. In particular, patients in the trial relapsed after a remission lasting no longer than 12 months, disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation, or relapsed or refractory ALL after two or more lines of systemic therapy.
The main focus of the trial was the rate and duration of complete remission achieved within three months after the infusion, according to the release. Other areas of interest included the rate and duration of overall complete remission, which included complete remission with or without incomplete hematologic recovery at any time.
Glossary
Complete remission: the disappearance of all signs of cancer as a result of treatment.
Hematologic recovery: restoration of normal blood counts after treatment, particularly white blood cells, red blood cells and platelets.
Immune effector cell-associated neurotoxicity syndrome: a neurological condition that may occur from CAR-T cell therapy caused by an immune response from the treatment. Symptoms include difficulty concentrating, confusion, headache, mood changes, seizures, muscle weakness/numbness and vision problems.
Cytokine release syndrome: a condition sometimes seen after CAR-T cell therapy when there is a large release of cytokines into the blood from immune cells, which may lead to symptoms including nausea, fever, rash, headache, low blood pressure, rapid heartbeat and trouble breathing.
Febrile neutropenia: fever and low counts of neutrophils, a type of white blood cell that helps fight infection.
Encephalopathy: a disorder that affects the brain’s function.
Of the 65 patients with evaluable information in the FELIX trial, 27 patients — or 42% — achieved complete remission within three months, with a median duration of complete remission within three months of 14.1 months.
According to the FDA, the prescribing information for Aucatzyl has a boxed warning for immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and T-cell malignancies. Of note, CRS occurred in 75% of patients in the FELIX trial, of which 3% were considered grade 3 (severe). Neurologic side effects also occurred in 64% of patients in the trial, of which 12% were considered grade 3 or worse. These neurologic side effects included ICANS, which was observed in 24% of patients, of which 7% were considered grade 3 or worse.
The most common side effects with Aucatzyl occurring in at least 20% of patients included infections with an unspecified pathogen, CRS, viral infections, musculoskeletal pain, bacterial infectious disorders, nausea, fever, febrile neutropenia, diarrhea, low blood pressure, ICANS, fatigue, pain, encephalopathy, headache and bleeding.
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