Scanning electron micrograph of a human T lymphocyte (additionally known as a T cell) from the immune system of a wholesome donor. Credit score: NIAID
Sufferers with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL) who had been handled with the novel anti-CD19 chimeric antigen receptor (CAR) T cell remedy, obecabtagene autoleucel (obe-cel), skilled excessive response charges and most didn’t want a subsequent stem cell transplant (SCT), in line with outcomes from the Section Ib/II FELIX trial co-led by researchers at The College of Texas MD Anderson Most cancers Heart.
The findings, revealed immediately within the New England Journal of Medication, confirmed a 76.6% response charge and 55.3% full remission charge in 127 evaluable sufferers. The median event-free survival (EFS) was 11.9 months, and the EFS charges at six and 12 months had been 65.4% and 49.5%, respectively. The median total survival (OS) for infused sufferers was 15.6 months. At six and 12 months, the estimated OS charges had been 80.3% and 61.1%, respectively.
Based mostly on these knowledge, the Meals and Drug Administration accepted obe-cel for the therapy of relapsed or refractory B-cell ALL in grownup sufferers in Nov. 2024. Extra findings from the research might be offered Dec. 9 on the 2024 American Society of Hematology (ASH) Annual Assembly by Elias Jabbour, M.D., professor of Leukemia and the research’s U.S. lead investigator.
“Patients with B-cell ALL need effective standalone treatment options, and obe-cel demonstrated strong long-term efficacy and response rates in patients treated on the FELIX study,” Jabbour mentioned. “Until now, these patients had limited treatment options. We observed minimal immunotoxicity and a strong persistence of CAR T cells, which support obe-cel being the standard of care for this population.”
The worldwide, multi-center FELIX trial handled 127 adults with relapsed or refractory B-cell ALL. Previous to receiving obe-cel, trial individuals had lymphodepletion—an essential step to eradicate current T cells and create a clean slate for CAR T cell remedy—adopted by obe-cel infusion in cut up doses on days one and 10. The median age of trial individuals was 47 years and 52% had been male. Sufferers had been 74% white, 12.6% Asian, 1.6% Black and 11.8% unknown.
Toxicities had been largely restricted to sufferers with excessive bone marrow burden. Sufferers skilled a low grade of cytokine launch syndrome (CRS) and neurotoxicity, that are related to CAR T cell therapies. Three sufferers skilled CRS signs of grade 3 or greater, and 9 sufferers skilled immune effector cell-associated neurotoxicity syndrome of grade 3 or greater. Noticed uncomfortable side effects had been in line with earlier research, and no new antagonistic results had been recognized.
Among the many 99 sufferers who responded to obe-cel, solely 18 went on to obtain a SCT whereas in remission at a median of 101 days after their infusion. Researchers noticed no distinction in EFS and OS between sufferers who acquired a SCT and those that didn’t, suggesting a sturdy response from obe-cel remedy.
The trial additionally demonstrated vital clearance of minimal residual illness (MRD) following obe-cel therapy. In sufferers with blood cancers, MRD refers to a small variety of most cancers cells remaining after therapy which have the potential to trigger relapse.
On the research, 68 high-risk sufferers—outlined as these with bone marrow blasts larger than 5% previous to lymphodepletion—achieved a whole remission. On this group, 62 sufferers had MRD knowledge out there, and 58 sufferers had been MRD-negative after obe-cel infusion.
Within the upcoming ASH presentation, Jabbour will spotlight the correlation between depth of MRD-negative remission and scientific outcomes in sufferers handled with obe-cel. Previous to lymphodepletion, researchers evaluated affected person bone marrow samples by subsequent era sequencing (NGS). The findings point out decrease ranges of MRD had been related to a stronger response, together with greater EFS and OS charges, Jabbour defined.
Extra data:
Claire Roddie et al, Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia, New England Journal of Medication (2024). DOI: 10.1056/NEJMoa2406526
Offered by
College of Texas M. D. Anderson Most cancers Heart
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Novel CAR T cell remedy obe-cel demonstrates excessive response charges in grownup sufferers with superior B-cell ALL (2024, November 28)
retrieved 28 November 2024
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