AUTL - Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023 | Benzinga
- Pooled analysis of the FELIX Phase Ib/II study demonstrated prolonged event free survival and low overall immunotoxicity across all cohorts in r/r B-ALL, and particularly in patients with low leukemic burden at lymphodepletion
- Longer-term data from a pooled analysis from the ALLCAR19 study and FELIX Phase Ib in r/r B-ALL showed durable remissions with obe-cel as a stand-alone therapy in a subset of patients after a median follow up of >3 years
- Additionally, ALLCAR19 extension cohorts demonstrated long-term responses with low immunotoxicity and prolonged persistence in patients with aggressive and indolent r/r NHL and r/r CLL
- Initial data from the MCARTY Phase I study in multiple myeloma showed AUTO8 was well tolerated, with responses observed in all patients
- Autolus will host an in-person and webcast Analyst/Investor event to discuss the data on Sunday, December 10, 2023 at 8:00 AM PT / 4.00 PM GMT
LONDON, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces two oral presentations and two poster presentations at the American Society of Hematology (ASH) Annual Meeting, December 9-12, 2023, including an oral presentation highlighting data from a pooled analysis of the FELIX Phase Ib/II study of obe-cel, an autologous fast off-rate CD19 CAR T therapy, in relapsed/refractory adult B-ALL; and as a poster presentation a long-term update on the pooled ALLCAR19 and FELIX phase 1b studies, evaluating obe-cel in adult patients with r/r B-ALL as well from the ALLCAR19 study patients with B-NHL and B-CLL. Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.
"The FELIX study, with 127 patients, is one of the largest CAR T cell studies in adults with r/r B-ALL. Obe-cel had a favorable safety profile with very low rates of severe CRS and ICANS, in a clinical setting where these toxicities tend to be frequent and severe. A high proportion of patients responded, with many responses sustained, particularly in patients with low or intermediate disease-burden at lymphodepletion. The FELIX study shows that obe-cel has the potential to become an important therapeutic option in adults with r/r B-ALL," said Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL).
"The data we are sharing at ASH from our prior studies indicate that a subset of relapsed and refractory adult ALL patients treated with obe-cel as a single agent continue in remission with a median follow-up of more than three years. It is gratifying to see the excellent safety profile, high response rate and event-free survival we observed in our prior studies, reproduced in the FELIX study," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We have recently submitted a Biologics License Application (BLA) for obe-cel to the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) and we look forward to working with the FDA through the regulatory approval process."
Abstract #222 - oral presentation:
Title: Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the Ongoing FELIX Phase Ib/II Study
Link to Presentation
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Expanding Disease Targets for CAR-T Cell Therapies
Session date and time: Saturday, December 9, 2023, 3:15 PM PT
Session room: San Diego Convention Center, Room 6B
Publication Number: 222
Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)
Summary:
Obe-cel is an autologous chimeric antigen receptor T cell product using a fast off-rate CD19 binding domain designed to reduce toxicity and increase long-term persistence. A pooled analysis of data from all patients across all cohorts in the FELIX Phase Ib/II study (morphologic disease, minimal residual disease (MRD), isolated extramedullary disease (EMD)) were presented (n=127, median follow-up time from first obe-cel infusion to data cut-off of 16.6 months). Median vein-to-release time was 22 days. Across all patients, treatment with obe-cel resulted in a high response rate with CR/CRi rate of 78% in evaluable patients. Additionally, obe-cel showed a favorable safety profile; grade ?3 CRS was 2% and grade ?3 ICANS was 7%, with most severe cases of immunotoxicity occurring in patients with high leukemic burden in the bone marrow (BM). The event free survival estimate (EFS) at 12-months was 50% across all patients, with only 17% of responders proceeding to stem cell transplant while in remission. For patients who had morphologic disease, defined as ?5% BM blasts or presence of EMD regardless of BM blast status, at lymphodepletion, 74% responded with CR or CRi, and 95% of evaluated responders were MRD-negative‡. For patients who did not have morphologic disease at lymphodepletion, 100% were MRD-negative§ after obe-cel infusion. Subgroup analysis demonstrated that EFS and safety, particularly rate of CRS and ICANS, were better in patients with lower disease burden at lymphodepletion (see table below). Cellular kinetic data shows high expansion and long-term persistence of CAR T cells in most responders.
Table: Summary EFS and safety by bone-marrow blasts prior to lymphodepletion