Aucatzyl (obecabtagene autoleucel) / Autolus - LARVOL DELTA

Efficacy and Safety Outcomes of Obecabtagene Autoleucel (obe-cel) Stratified by Age in Patients with r/r B-ALL (The Manila Times) - P1/2 | N=153 | FELIX (NCT04404660) | Sponsor: Autolus Limited | "Obe-cel treatment was associated with deep and durable remissions resulting in favorable overall remission rate, event free survival, and overall survival with low incidence of Grade ≥3 CRS and ICANS in both age groups (<55 years and ≥55 years). These findings indicate that obe-cel is effective and has a positive benefit and risk profile regardless of patient age, including in older adults with R/R B-ALL."

P1/2 data • B Acute Lymphoblastic Leukemia

Predicting Hematotoxicity Risk and Outcomes in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-All): Should Hematotox Models be CAR Specific Rather than Disease Specific (The Manila Times) - P1/2 | N=153 | FELIX (NCT04404660) | Sponsor: Autolus Limited | "Although both the CAR-Hematotox (CAR-HT) model, and the ALL-Hematotox (ALL-HT) model show potential, ALL-HT appears to improve risk stratification and may be a better predictor of response, survival and safety outcomes in adult patients with r/r B-ALL treated with obe-cel, than CAR-HT."

P1/2 data • B Acute Lymphoblastic Leukemia

Autolus Therapeutics Presents Long-Term Follow Up from the FELIX Study Demonstrating Obe-Cel's Potential for Long-Term Remission in R/R B-ALL at the 2025 European Hematology Association (EHA) Congress (The Manila Times) - P1/2 | N=153 | FELIX (NCT04404660) | Sponsor: Autolus Limited | "At the updated median follow up of 32.8 months, 38.4% of responders were in ongoing remission without consolidative SCT or other therapies (versus the previously reported 40% at a median follow up of 21.5 months). The 24-month probability of Event Free Survival was 43%, and for Overall Survival was 46%, with an emerging long-term plateau observed. A substantial subset of patients benefit from standalone treatment with obe-cel, achieving long-term remission. No new safety signals or Grade ≥3 secondary malignancies were observed at the extended follow-up. These results suggest that obe-cel may be a definitive treatment for some patients with r/r B-ALL - specific analysis will be needed to determine which patients may need additional treatments."

P1/2 data • B Acute Lymphoblastic Leukemia

CARLYSLE: a Phase I trial in progress evaluating the safety and efficacy of obecabtagene autoleucel in severe, refractory systemic lupus erythematosus (SLE) (UKKW 2025) - P1 | "Patients must be refractory to previous standard of care medications, including hydroxychloroquine in combination with corticosteroids and to ≥2 treatment groups of immunosuppressive drugs, B-cell targeting agents or cytokine inhibitors. Eligible patients may receive bridging therapy before lymphodepletion with fludarabine (3×25 mg/m²) and cyclophosphamide (1,000 mg/m²) prior to obe- cel infusion...All four infused patients have significant biopsy-proven renal disease. Discussion CARLYSLE is an ongoing trial currently enrolling patients with severe, refractory SLE in centres in UK and Spain."

Clinical • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Leukemia • Lupus • Nephrology • Oncology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

CD-19 CAR-T cell therapy in adult B-cell ALL patients: A systematic review of clinical trials. (ASCO 2025) - "CD19 CAR-T cell therapies, including Obe-cel, KTE-X19, UCART19, and GC007g, have demonstrated efficacy and safety in the treatment of relapsed/refractory (RR) adult B-cell ALL patients. Among these, Obe-cel stands out with a lower incidence of severe cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), making it a promising therapy for outpatient administration. However, large-scale, randomized, multi-center clinical trials are essential to validate these findings and further refine the role of CD19 CAR-T therapies in this high-risk population."

CAR T-Cell Therapy • Clinical • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

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 | "A higher proportion of pts aged <55 yrs were Hispanic/Latino (36.7% vs 18.8%), had extramedullary disease at lymphodepletion (LD; 29.1% vs 8.3%), received prior blinatumomab (53.2% vs 22.9%), and prior inotuzumab ozogamicin (35.4% vs 25.0%) than those ≥55 yrs, while a higher proportion of pts aged ≥55 yrs had Philadelphia chromosome-positive disease (47.9% vs 16.5%)... Obe-cel treatment resulted in favorable ORR and EFS with low Grade ≥3 CRS/ICANS incidence in both age groups. These findings indicate that obe-cel is effective and has a positive benefit/risk profile regardless of age, including in older adults with R/R B-ALL despite few receiving consolidative SCT."

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

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025 (European Medicines Agency) - "On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Aucatzyl, intended for the treatment of adults from 26 years of age with relapsed or refractory B cell precursor acute lymphoblastic leukaemia....Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL)."

CHMP • B Acute Lymphoblastic Leukemia

EFFICACY AND SAFETY OUTCOMES OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) STRATIFIED BY AGE IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) (EHA 2025) - P1/2 | "A higher proportion of pts aged <55 years were Hispanic/Latino (36.7% vs 18.8%), had extramedullary disease at lymphodepletion (29.1% vs 8.3%), and had received prior blinatumomab (53.2% vs 22.9%), and/or prior inotuzumab ozogamicin (35.4% vs 25.0%) vs those aged ≥55 years... Obe-cel treatment was associated with deep and durable remissions resulting in favorable ORR, EFS, and OS with low incidence of Grade ≥3 CRS and ICANS in both age groups. These findings indicate that obe-cel is effective and has a positive benefit and risk profile regardless of pt age, including in older adults with R/R B-ALL, despite few pts receiving consolidative SCT"

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

CAN CAR T-CELL THERAPY BE A DEFINITIVE TREATMENT FOR ADULT R/R B-ALL WITHOUT TRANSPLANT? LONG-TERM FINDINGS AND PREDICTORS OF SUSTAINED REMISSION FOR OBECABTAGENE AUTOLEUCEL (EHA 2025) - P1/2 | "Stepwise variable selection was performed to identify the list of important factors in the final model.Important factors identified from the UVA included: age (3), response status to first and last line of therapy, previous allogeneic SCT and previous inotuzumab ozogamicin prior to leukapheresis... Obe-cel persistence, low disease burden at LD and obe-cel use in earlier lines were independent factors associated with better outcomes and longer survival in adult pts with R/R B-ALL. These data re-enforce that obe-cel persistence is important in achieving long-term survival without additional treatments, suggesting the potential of obe-cel as a definitive treatment."

CAR T-Cell Therapy • Clinical • Hematological Disorders • Transplantation

PREDICTING HEMATOTOXICITY RISK AND OUTCOMES IN RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL): SHOULD HEMATOTOX MODELS BE CAR SPECIFIC RATHER THAN DISEASE SPECIFIC (EHA 2025) - P1/2 | "A higher proportion of CAR-HT low-risk (80.0%) vs high-risk pts (51.0%) received prior blinatumomab or inotuzumab ozogamicin... Although both models show potential, ALL-HT appears to improve risk stratification and may be a better predictor of response, survival and safety outcomes in adult pts with R/R B-ALL treated with obe-cel, than CAR-HT. Taken together with other published reports, our data suggest that the strength of HT-model predictions may be CAR specific. Further analyses are needed."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP

Autolus Therapeutics Presents Clinical Data Updates at the 2025 European Hematology Association (EHA) Congress (GlobeNewswire) - "Autolus Therapeutics plc...announces the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 12-15, 2025, Milan, Italy. Autolus will have two oral and one poster presentation, which includes updated follow up from the FELIX study of obecabtagene autoleucel (obe-cel) in adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL)."

Clinical data • Acute Lymphocytic Leukemia

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

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