Aucatzyl (obecabtagene autoleucel) / Autolus - LARVOL DELTA

Durable responses and favourable toxicity after fast off-rate CD19 CAR T-cell therapy with obecabtagene autoleucel in adults with relapsed/refractory B-cell malignancies (ICML 2025) - No abstract available

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Lymphoma • Oncology

Autolus Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "Autolus Therapeutics plc...announces its operational and financial results for the first quarter ended March 31, 2025....'In the second quarter we are planning to share longer-term follow-up data from the FELIX study, and in the second half of the year we plan to announce data from the pediatric PY1 trial.'"

P1 data • P1/2 data • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

Efficacy and safety outcomes of obecabtagene autoleucel (obe-cel) stratified by age in patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04404660 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Key updates and anticipated milestones (GlobeNewswire) - "Obe-cel in lupus nephritis (LN): The Company has aligned with U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential registrational path to approval and anticipates dosing the first patient in a Phase 2 trial before the end of 2025; Full data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is targeted for presentation at a medical conference in the second half of 2025...Obe-cel in progressive MS: Autolus plans to advance obe-cel into clinical development in progressive MS. The Company expects to dose its first patient in a Phase 1 dose escalation study by year-end 2025."

New P1 trial • New P2 trial • P1 data • Lupus Nephritis • Multiple Sclerosis • Systemic Lupus Erythematosus

CARLYSE: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Autolus Limited | Trial completion date: Oct 2025 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Autolus Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "AUCATZYL Launch: Autolus reported Q1 2025 net product sales of $9.0 million; The Company has 39 centers fully activated in the U.S. as of May 7, 2025...Obe-cel is under regulatory review in the EU and the Company expects to receive notification of approval status from the European Medicines Agency (EMA) in the second half of 2025."

EMA approval • Launch US • Sales • B Acute Lymphoblastic Leukemia

Autolus Therapeutics Announces License of AUCATZYL (obecabtagene autoleucel) Issued by UK MHRA for Adult Patients (≥ 18 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) (GlobeNewswire) - "Autolus Therapeutics...announces today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)....The MHRA authorisation of AUCATZYL was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia....Autolus submitted obecabtagene autoleucel for appraisal by the National Institute for Health and Care Excellence (NICE) in Q4 2024 and is working with NICE and the NHS to potentially achieve access for eligible patients in England."

MHRA approval • NICE • B Acute Lymphoblastic Leukemia

Tumour Burden-Guided Dosing in the FELIX Study of Obecabtagene autoleucel in Adult R/R B-ALL (BSH 2025) - No abstract available

Clinical • Oncology

OUTCOMES OF PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL) TREATED WITH OBECABTAGENE AUTOLEUCEL (OBE-CEL) WITH OR WITHOUT CONSOLIDATIVE ALLOGENEIC STEM CELL TRANSPLANTATION (SCT) (EBMT 2025) - P1/2 | "Patients received bridging therapy as appropriate and underwent lymphodepletion (fludarabine, 4×30mg/m2; cyclophosphamide, 2×500mg/m2), followed by tumour burden (TB)-guided split dosing (Days 1 and 10) to a total target dose of 410×106 CAR T-cells...Median number of prior therapies in both groups was two, with a higher rate of blinatumomab exposure (67% vs 32%), and lower rate of prior SCT (33% vs 51%) in transplanted vs non-transplanted patients... Despite small samples, this analysis demonstrates SCT does not appear to improve EFS/OS. Further studies could clarify optimal post-CAR T-cell management. Lower TB at lymphodepletion was associated with improved EFS without SCT."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

OBECABTAGENE AUTOLEUCEL (OBE-CEL) VERSUS EXTERNAL CONTROL ARM (ECA) MATCHED COMPARISONS IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL) (EBMT 2025) - P1/2 | "Efficacy and safety were compared for patients treated with obe-cel (modified intent-to-treat [mITT]) and all enrolled patients (intent-to-treat [ITT]) versus matched ECA patients treated with SOC (≥1 dose of blinatumomab, inotuzumab ozogamicin or salvage chemotherapies)... Obe-cel demonstrated higher ORR, longer OS and EFS versus SOC in matched ECAs, alongside a manageable safety profile. These data support a positive benefit-risk profile with obe-cel for the treatment of adult R/R B-ALL. Clinical Trial Registry: NCT04404660; https://www.clinicaltrials.gov/study/NCT04404660"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology

OBECABTAGENE AUTOLEUCEL (OBE-CEL) FOR RELAPSED/REFRACTORY ADULT B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL): THE IMPACT OF INOTUZUMAB-CONTAINING BRIDGING THERAPY ON TREATMENT OUTCOMES (EBMT 2025) - P1/2 | "Patients received BT (chemotherapy with or without INO or tyrosine kinase inhibitors [TKI], single-agent INO, single-agent TKI, steroids, or rituximab) per investigator decision. Patients underwent lymphodepletion (fludarabine, 4×30mg/m2; cyclophosphamide, 2×500mg/m2), followed by obe-cel tumour burden-guided infusions (Days 1 and 10), to a total target dose of 410×106 CAR T-cells... INO-containing bridging therapies were utilised in patients with highest disease burden and were effective in reducing BM blast percentage and contributed to minimise the risk of immunotoxicity. Thus, choice of BT prior to obe-cel, though influenced by clinical care variables may impact outcomes. Further studies comparing bridging with INO-containing therapies/chemotherapy are warranted."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

SAFETY, EFFICACY AND CAR T-CELL PERSISTENCE OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN PATIENTS ≥55 YEARS OLD, WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL) (EBMT 2025) - P1/2 | "Background: Treatment of patients aged ≥55 years with R/R B-ALL is challenging; standard therapies, such as blinatumomab and inotuzumab ozogamicin, are associated with worse outcomes and/or undesirable toxicities...Recently, CD19 chimeric antigen receptor (CAR) T-cell therapies, such as brexucabtagene autoleucel and obe-cel, have been approved in the US for adult R/R B-ALL; however, limited data are available in patients ≥55 years... Treatment of patients aged ≥55 years with R/R B-ALL using obe-cel results in a high and durable remission rate with low incidence of severe CRS and ICANS. These data are consistent with those from the overall FELIX population and suggest that obe-cel has a positive benefit/risk profile and is effective in a broad patient population, including patients aged ≥55 years. Clinical Trial Registry: NCT04404660; https://www.clinicaltrials.gov/study/NCT04404660"

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Thrombocytopenia

SAFETY, EFFICACY AND CAR T-CELL PERSISTENCE OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN PATIENTS ≥55 YEARS OLD, WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL) (EBMT 2025) - P1/2 | "Background: Treatment of patients aged ≥55 years with R/R B-ALL is challenging; standard therapies, such as blinatumomab and inotuzumab ozogamicin, are associated with worse outcomes and/or undesirable toxicities...Recently, CD19 chimeric antigen receptor (CAR) T-cell therapies, such as brexucabtagene autoleucel and obe-cel, have been approved in the US for adult R/R B-ALL; however, limited data are available in patients ≥55 years... Treatment of patients aged ≥55 years with R/R B-ALL using obe-cel results in a high and durable remission rate with low incidence of severe CRS and ICANS. These data are consistent with those from the overall FELIX population and suggest that obe-cel has a positive benefit/risk profile and is effective in a broad patient population, including patients aged ≥55 years. Clinical Trial Registry: NCT04404660; https://www.clinicaltrials.gov/study/NCT04404660"

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Thrombocytopenia

Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates (GlobeNewswire) - "Obe-cel in B-cell mediated autoimmune diseases: The Phase 1 dose confirmation clinical trial (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients is ongoing, with all six patients dosed. Autolus will present the initial data from this trial and development plans at its R&D event being held on April 23, 2025, and is targeting H2 2025 for the presentation of full data with longer term patient follow-up."

P1 data • Systemic Lupus Erythematosus

Awakening from REMS: ASTCT 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells. (PubMed, Transplant Cell Ther) - "The seventh commercial CAR-T product (Aucatzyl® or obecabtagene autoleucel) was the first approved without a REMS program as of November 8th, 2024. Continued streamlining of already widespread CAR-T safety standards for existing and future approved CAR-T and other unique cell therapy products and ensuring their adoption at new and existing treatment centers will be required to maintain and increase access to the ever-growing number of effective adoptive cell therapies."

Journal • Review • Developmental Disorders • Inflammation • Transplantation

Intermediate-affinity CD19-directed CAR T cell product obecabtagene autoleucel demonstrates favourable safety and efficacy in R/R B-ALL. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal

ObeCel (TCT-ASTCT-CIBMTR 2025) - No abstract available

An Economic Model Comparing the Costs Associated with Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Among Patients Treated with Chimeric Antigen Receptor (CAR) T-Cell Therapies for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) (TCT-ASTCT-CIBMTR 2025) - P1/2 | "Objectives: To estimate the cost of CRS and ICANS in pts with R/R B‑ALL treated with obe-cel or brexucabtagene autoleucel (brexu-cel)... Obe-cel was associated with lower CRS- and ICANS-related healthcare costs versus brexu-cel, primarily due to lower rates of Gr 3/4 AEs and faster resolution of these events. These results suggest that obe-cel improves resource utilization and reduces healthcare costs versus other CAR T-cell therapies for R/R B-ALL."

Clinical • Cytokine release syndrome • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Comparison of Obecabtagene Autoleucel (obe-cel) Versus an External Control Arm (ECA) in Adult Patients (pts) with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) (TCT-ASTCT-CIBMTR 2025) - P1/2 | "Efficacy and safety outcomes were compared in pts treated with obe-cel (modified intent-to-treat [mITT]) and all enrolled pts (ITT) vs matched ECA pts treated with SOC (≥1 dose of blinatumomab, inotuzumab ozogamicin, or salvage chemotherapies)... Obe-cel demonstrated higher ORR and longer OS and EFS vs SOC in matched ECAs. Safety was comparable between treatment groups, demonstrating a positive benefit-risk profile of obe-cel for treatment of adult R/R B-ALL."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Oncology

Always more immunotherapy in the management of B-lineage acute lymphoblastic leukemia. (PubMed, Med) - "The high responses associated with the low incidence of grade ≥3 side effects make obe-cel an attractive candidate for a broader use of CAR-T cells in B-ALL. Its impact will have to be weighed with the monoclonal antibody blinatumomab in the frontline treatment of B-ALL."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Obe-Cel Is Associated With Improved Outcomes in R/R B-ALL With Low-Risk CAR-HT Scores (OncLive) - P1/2 | N=153 | NCT04404660 | Sponsor: Autolus Limited | "Treatment with obecabtagene autoleucel (obe-cel; Aucatzyl) was associated with improved outcomes in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) with low-risk CAR-HEMATOTOX (CAR-HT) scores vs those with high-risk scores, according to data from analysis of the phase 1/2 FELIX trial (NCT04404660) presented at the 2025 Transplantation and Cellular Therapy Meetings....At a median follow-up of 21.5 months (range, 8.6-41.4), patients in the low-risk group experienced an overall response rate (ORR) of 96.0% (95% CI, 79.6%-99.9%) compared with 73.5% (95% CI, 63.9%-81.8%) for those in the high-risk group. Additionally, 20.8% of patients in the low-risk group proceeded to allogeneic stem cell transplant (allo-SCT) vs 17.3% of patients in the high-risk group."

P1/2 data • B Acute Lymphoblastic Leukemia

Obecabtagene Autoleucel for B-Cell Acute Lymphoblastic Leukemia. (PubMed, JAMA) - No abstract available

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Obecabtagene Autoleucel: First Approval. (PubMed, Mol Diagn Ther) - "Obecabtagene autoleucel received approval following positive results from the FELIX phase I/II trial in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and it is the first CAR T therapy that does not have mandatory Risk Evaluation Mitigation Strategy monitoring requirements. This article summarizes the milestones in the development of obecabtagene autoleucel leading to this first approval for the treatment of adults with relapsed or refractory B-cell precursor ALL."

Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Leukemia • Lupus • Oncology • Systemic Lupus Erythematosus

ASH 2024: Breakthrough Insights on CAR T-Cell Therapy for Relapsed/Refractory ALL : Episode 1: Introduction to CAR T-Cell Therapies in R/R ALL (OncLive) - "Panelists discuss how the recent FDA approval of obecabtagene autoleucel (obe-cel) for relapsed/refractory acute lymphoblastic leukemia (R/R ALL) adds to the existing chimeric antigen receptor (CAR) T-cell therapies, with a focus on the differences in their mechanisms, structures, and FDA indications."

Video

Expanded Access Program for OOS Obe-cel (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Autolus Limited

New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology