Aloof CAR T-Cell Remedy Accredited for Leukemia

— Obecabtagene autoleucel has no requirement for a REMS program

by Ian Ingram, Managing Editor, MedPage Today time November 8, 2024

The FDA authorized obecabtagene autoleucel (obe-cel; Aucatzyl) for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults, the agency offered on Friday.

Of point to, now not like other CAR T-cell therapies, the CD19-directed genetically modified autologous T-cell immunotherapy can occupy no requirement for a Threat Overview and Mitigation Technique (REMS) program.

Approval used to be supported by the sole-arm, multicenter FELIX trialwhich enrolled patients with relapsed or refractory CD19-certain B-cell ALL.

Amongst the 65 patients evaluable for efficacy, a single infusion of obe-cel yielded a total remission (CR) rate of 42% (95% CI 29-54) at 3 months. Of these responders, the median length of CR reached 14.1 months. Overall, 63% of contributors finished a CR for the length of the gaze, including 12% with CR and incomplete hematologic recovery.

“Aucatzyl is extremely active and would possibly per chance per chance additionally also be well managed, offering a beautiful likelihood-profit profile for B-ALL patients,” investigator Claire Roddie, MD, PhD, of the College College London Most cancers Institute, said in a assertion from drugmaker Autolus Therapeutics. “Within the FELIX trial, Aucatzyl has shown prolonged-duration of time persistence and deep responses, which we mediate are severe for prolonged-duration of time remissions in B-ALL.”

Patients enrolled in the half Ib/II trial had to occupy relapsed following a outdated remission of a year or less, occupy relapsed or refractory ALL after as a minimal two outdated traces of therapy, or occupy disease that relapsed or used to be refractory 3 or extra months after allogeneic stem-cell transplantation.

“Adult ALL is an awfully aggressive cancer, and there would possibly per chance be a excessive unmet scientific need that exists in the therapy of patients with this disease when they relapse, where historically they undergo from miserable outcomes,” investigator Elias Jabbour, MD, of the College of Texas MD Anderson Most cancers Center in Houston, said in an announcement.

Love other CAR T-cell therapies, the drug’s labeling has a boxed warning over dangers of cytokine free up syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and secondary T-cell malignancies. Within the FELIX trial, CRS came about in 75% of patients (with 3% grade 3 in severity), whereas ICANS came about in 24% (with 7% grade ≥3). Overall, neurologic toxicities came about in 64% (12% grade ≥3).

Other authorized non-laboratory hostile occasions, going on in 20% or extra of contributors, included infections and bacterial infectious complications, musculoskeletal pain, fever, nausea, diarrhea, febrile neutropenia, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.