On December 9, 2024 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported an oral presentation and three poster presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held from December 7-10, 2024, in San Diego (Press release, Autolus, DEC 9, 2024, View Source [SID1234648932]).

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"Our oral presentation at ASH (Free ASH Whitepaper) this year with data from the FELIX trial demonstrates that obe-cel treatment produces a high incidence of deep molecular remission in r/r adult ALL patients, which correlates with better outcomes and is associated with longer event free survival (EFS) and overall survival (OS)," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We’re also presenting three posters that aim to further our understanding of the use of obe-cel in a real-world context, suggesting the positive clinical outcomes of obe-cel even after effective bridging therapy; the reduced healthcare resource utilization costs associated with lower severity of ICANS and CRS; and how hematotoxicity scores could help identify patients who are at higher risk for hematotoxicity from treatment with obe-cel."

Abstract 194508 – Oral presentation:
Title: Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes
Session Name: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Risk Stratification and CAR-T Therapies
Session date and time: Monday, December 9, 2024. 4:30 PM – 6:00 PM PT
Presentation Time: 5:00 PM
Session room: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 5-6
Publication Number: 963
Presenting Author: Dr. Elias Jabbour, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX

Summary: Obe-cel treatment produces a high incidence of deep remission, which is predictive of better clinical outcomes. The majority of responders to obe-cel achieved deep remission to MRD <10–6 level (84%, 57/68), measured by clonoSEQ NGS assay. Deep MRD remission correlates with better outcomes and is associated with longer event free survival (EFS) and overall survival (OS). The largest EFS and OS benefit was seen with lower tumor burden at lymphodepletion.

Abstract 201514 – Poster presentation:
Title: Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in the Open-Label, Multi-Center, Global, Single-Arm, Phase Ib/II FELIX study: The Impact of Bridging Therapies on CAR T-Cell Expansion and Persistence
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials & Toxicities: Poster II
Session date and time: Sunday December 8, 2024; 6:00 PM – 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 3458
Presenting Author: Dr. Jae H Park, Leukemia Specialist & Cellular Therapist, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Summary: Comparable expansion and long-term persistence of obe-cel was observed with all the bridging therapies evaluated, suggesting that long-term persistence of obe-cel is possible irrespective of the bridging therapy and independent of disease burden at lymphodepletion. Bridging therapy with inotuzumab ozogamicin was effective in reducing disease burden prior to lymphodepletion and obe-cel infusion. Reduction in disease burden at lymphodepletion through bridging therapy led to improved event-free survival and overall survival compared to bridging therapy without INO and maintained a tolerable safety profile.

Abstract 205694 – Poster presentation:
Title: Healthcare Resource Utilization and Costs Associated with Managing CRS and ICANS in Patients with Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia Receiving Obecabtagene autoleucel (obe-cel)
Session Title: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Session date and time: Monday December 9, 2024; 6:00 PM – 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 4837
Presenting Author: Dr. Bijal D Shah, Associate Member in the Department of Malignant Hematology Moffitt Cancer Center, Tampa, FL, USA

Summary: Grade ≥3 cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) are associated with increased healthcare resource utilization (HCRU) and costs, but these events were rare in the FELIX study. Costs for adverse events generally increase with event severity. Medication usage and intensive care unit costs were key drivers of CRS and/or ICANS management costs. Obe-cel has the potential to optimize utilization of resources and reduce costs associated with CAR T-cell therapy for patients with R/R B-ALL as a result of the low incidence of Grade ≥3 CRS and/or ICANS.

Abstract 208028 – Poster presentation:
Title: Risk Factors Associated with Sub-Optimal Outcomes Following Obecabtagene autoleucel (obe-cel) for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): What We Have Learned from the FELIX Trial
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials & Toxicities: Poster III
Session date and time: Monday, December 9, 2024; 6:00 PM – 8:00 PM PT
Session room: San Diego Convention Center, Halls G-H
Publication Number: 4845
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary: The CAR-HEMATOTOX risk score correlated with disease burden in this patient population – patients with high-risk CAR-HEMATOTOX scores had consistently worse outcomes than patients with low-risk CAR-HEMATOTOX scores. Risk-stratification, using pre-lymphodepletion clinical parameters together with disease burden, has the potential to be a useful tool for identifying patients at a high risk for hematotoxicity who may benefit from obe-cel treatment.