Press Releases May 21, 2026 05:10 PM

Autolus Therapeutics to Present Clinical Data Update at the American Society of Clinical Oncology Annual Meeting 2026

Autolus Therapeutics to present promising clinical data on obe-cel therapy for relapsed/refractory B-ALL at ASCO 2026

By Avery Klein AUTL

Autolus Therapeutics announced publication and upcoming presentation of clinical data from the FELIX Phase Ib/II trial on their T cell therapy candidate obe-cel at the ASCO 2026 meeting. The data shows a 59% overall response rate and median duration of response of 42.6 months in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) with extramedullary disease (EMD), a difficult to treat population. This supports the positive benefit-risk profile of obe-cel and suggests it as a potential treatment option for these patients.

Autolus Therapeutics to Present Clinical Data Update at the American Society of Clinical Oncology Annual Meeting 2026
AUTL

Key Points

  • Obe-cel demonstrated a 59% overall response rate in r/r B-ALL patients with extramedullary disease, with a median duration of response of 42.6 months.
  • Data comes from post-hoc analysis of the Phase Ib/II FELIX study using tumor burden-guided dosing to minimize toxicity.
  • Positive benefit-risk profile observed even in adverse risk patients, supporting clinical potential of obe-cel.

LONDON and GAITHERSBURG, Md., May 21, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, announces the online publication of an abstract submitted to the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois.

“Data to be presented at the upcoming ASCO Annual Meeting provides insight into the use of obe-cel in patients with B-ALL and extramedullary disease (EMD), which is typically associated with shorter median and long-term survival compared to marrow-only relapse. With an overall response rate of 59% and a median duration of response (mDOR) of 42.6 months for patients with EMD, obe-cel may be considered as a potential treatment option for this difficult to treat population of patients,” said Matthias Will, MD, Autolus Chief Development Officer.

Abstract 6517
Title: The effect of obecabtagene autoleucel (obe-cel) on adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and extramedullary disease (EMD).
Session Type and Track: Rapid Oral Abstract: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.
Session Date and Time: May 30, 2026; 1:15 – 2:45PM CDT
Session Room: E450a
Abstract Number: 6517
Presentation time: 2:27 – 2:33pm CDT
Presenting Author: Jae Park, MD, Director, Adult ALL Program | Acting Chief, Cellular Therapeutics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Summary: A post-hoc analysis of the Phase Ib/II FELIX study (NCT04404660) was conducted, evaluating the efficacy and safety of obe-cel in patients with relapsed or refractory (r/r) B-ALL, by EMD status at lymphodepletion (LD). Following LD, adults with r/r B-ALL received obe-cel using a tumor burden-guided dosing strategy to minimize toxicity. Obe-cel treatment demonstrated favorable response and safety outcomes in patients with and without EMD in the FELIX trial. Of 127 obe-cel infused patients, 27 (21%) had EMD at LD. Among responders, duration of response in patients with EMD was 42.6 months, and the overall remission rate was 59%. Overall, these findings suggest a positive benefit–risk profile for obe-cel, including for patients with adverse risk features, specifically EMD at LD.

About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL®, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.

Contact:

Amanda Cray
+1 617-967-0207
[email protected]


Risks

  • Results are from a post-hoc analysis and Phase Ib/II trial data, indicating that larger confirmatory studies are still needed to establish definitive efficacy and safety.
  • Relapsed/refractory B-ALL with extramedullary disease remains a difficult to treat subgroup, so response may vary in broader patient populations.
  • Potential safety and toxicity concerns remain inherent to T cell therapies and require ongoing monitoring during clinical development.

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