NICE Recommends Obe-Cel for Adult R/R B-ALL

The National Institute for Care and Excellence (NICE) has recommended obecabtegene autoleucel (obe-cel; Aucatzyl) as a treatment option for adult patients at least 26 years of age with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL), according to an announcement from Autolus Therapeutics.1

Obe-cel is a CD19-targeted CAR T-cell therapy that received conditional marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025, based on data from the open-label, multicenter phase 1b/2 FELIX trial (NCT04404660). Findings from cohort 2A of the study published in the New England Journal of Medicine showed that at a median follow-up 20.3 months, evaluable patients (n = 94) achieved an overall remission rate of 77% (95% CI, 67%-85%), a complete remission (CR) rate of 55% (95% CI, 45%-66%), and CR with incomplete hematologic recovery rate of 21% (95% CI, 14%-31%).2

Additionally, at a median follow-up of 21.5 months, patients who received at least 1 infusion of obe-cel infusion (n = 127) experienced a median event-free survival of 11.9 months (95% CI, 8.0-22.1). The estimated 6- and 12-month EFS rates were 65.4% and 49.5%, respectively. Patients in this group also experienced a median overall survival (OS) of 15.6 months (95% CI, 12.9-not evaluable), with estimated 6- and 12-month OS rates of 80.3% and 61.1%, respectively.

“We believe obe-cel autoleucel represents an important new treatment option for eligible adult R/R B-ALL patients. NHS clinical centers and UK patients participated in the development of obe-cel, and we are looking forward to supporting patients and physicians in England and Wales now with the commercial product,” Christian Itin, PhD, chief executive officer of Autolus Therapeutics, stated in a news release.1

In November 2024, the FDA approved obe-cel for the treatment of adult patients with relapsed or refractory B-ALL, with this regulatory decision also supported by data from FELIX.3

How was the FELIX study of obe-cel in relapsed/refractory B-ALL designed?

FELIX enrolled patients at least 18 years of age with relapsed/refractory B-ALL who had documented CD19-positive disease within 1 month of screening.3 Patients also needed to have an ECOG performance status of 0 or 1 and adequate renal and cardiac function. Notably, patients with Philadelphia chromosome–positive ALL were allowed to enroll if they were intolerant to a TKI, experienced disease progression on 2 lines of any TKI, progressed on 1 line with a second-generation TKI, or were contraindicated for a TKI.

In phase 1b, patients needed to have a bone marrow blast level of at least 5% at screening (cohort 1A) or be minimal residual disease (MRD) positive with a bone marrow blast level of less than 5% at screening (cohort 1B). In phase 2, cohort 2A included patients with a bone marrow blast level of at least 5%, and cohort 2B featured patients in second or greater CR/CRi who had MRD-positive disease and a bone marrow blast level of less than 5%.

If patients had a diagnosis of Burkitt’s leukemia or lymphoma, a history of presence of clinically relevant central nervous system pathology, active or latent Hepatitis B or C, or prior CD19 targeted therapy other than blinatumomab (Blincyto), they were not included in the study.

Following lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine, obe-cel was given as a split-dose infusion, with the first administered on day 1 and the second given on day 10 (±2 days), for a target total dose of 4 x 106 CD19-positive CAR T cells.

The trial’s primary end points were to measure the frequency and severity of adverse effects (AEs), in addition to ORR. Secondary end points included MRD-negative CR rate, CR rate, duration of remission, progression-free survival, OS, and additional safety objectives.

“B-ALL is an aggressive disease with a poor prognosis, and there remains a need for additional treatment options. Today’s announcement marks an important step towards enabling more patients in England and Wales to access this CAR T[-cell] therapy. Anthony Nolan, together with our partners Leukaemia Care and Leukaemia UK, welcomes this progress and looks forward to working with the NHS to help make [obe-cel] available to adult [patients with] relapsed or refractory B-ALL in due course,” Henny Braund, MBE, chief executive officer of Anthony Noland, added in a news release.1

References

1. NICE recommends Aucatzyl (obecabtagene autoleucel) as a treatment option for adult patients (≥26 years) with relapsed or refractory B-Cell precursor acute lymphoblastic leukemia (R/R B-ALL). News Release. November 25, 2025. Accessed December 1, 2025. https://www.globenewswire.com/news-release/2025/11/25/3194072/0/en/NICE-Recommends-AUCATZYL-obecabtagene-autoleucel-as-a-Treatment-Option-for-Adult-Patients-26-years-with-Relapsed-or-Refractory-B-Cell-Precursor-Acute-Lymphoblastic-Leukemia-R-R-B-A.html
2. Roddie C, Sandhu K, Tholouli E, et al. Obecabtagene autoleucel in adults with B-Cell acute lymphoblastic leukemia. N Engl J Med. 2024;391:2219-2230. doi:10.1056/NEJMoa2406526
3. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. FDA. November 8, 2024. Accessed December 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute
4. A study of CD19 targeted CAR T cell therapy in adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia (ALL). Clinicaltrials.gov. Updated September 9, 2025. Accessed December 1, 2025. https://clinicaltrials.gov/study/NCT04404660