Autolus Therapeutics Announces Publication of Data from the FELIX study of obe-cel in r/r Adult B-ALL Patients in The New England Journal of Medicine
Rhea-AI Summary
Autolus Therapeutics published data from the FELIX study of obe-cel in The New England Journal of Medicine, showing promising results for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia treatment. The study demonstrated a 76.6% overall response rate in the pivotal cohort, with a median follow-up of 20.3 months. The treatment showed low immune-related toxicity, with Grade ≥3 CRS and ICANS observed in only 2.4% and 7.1% of patients respectively. The 12-month event-free survival rate was 49.5%. Obe-cel was recently approved by the FDA as AUCATZYL® and is under review by EU and UK regulators.
Positive
- High overall response rate of 76.6% in pivotal cohort
- Median response duration of 21.2 months across all infused patients
- Low toxicity profile with Grade ≥3 CRS at 2.4% and ICANS at 7.1%
- FDA approval achieved on November 8, 2024
- Median CAR T persistence of 17.8 months
Negative
- 12-month event-free survival rate to 49.5%
- Lower efficacy in high bone marrow burden patients (25% 12-month EFS)
- 15.7% of patients required ICU admission
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- High overall response rate:
76.6% of patients in the pivotal cohort achieved CR/Cri following treatment with obe-cel with a median follow-up of 20.3 months - Low incidence of immune-related toxicity: Grade ≥ 3 CRS and ICANS were observed in
2.4% and7.1% of infused patients respectively - High rates of durable response: 12-month event free survival of
49.5% in all patients who received at least one infusion
LONDON, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the New England Journal of Medicine has published data from the pivotal Phase 1b/2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The data demonstrate high rates of durable responses with low incidence of grade ≥3 immune-related toxicity.
“With its low rates of serious side effects coupled with compelling long-term survival data and durable responses, obe-cel offers real hope for adult lymphoblastic leukemia patients,” said Dr. Claire Roddie, MD, PhD, FRCPath, Lead investigator of the FELIX study and Associate Professor of Haematology at the University College London (UCL) Cancer Institute. “Obe-cel’s durable responses were particularly observed in patients with low-intermediate bone marrow burden, including patients who did not receive consolidative allo-Stem Cell Transplant and there could be an opportunity to use obe-cel as earlier-line consolidation.”
“Adult ALL is an extremely aggressive cancer and patients with this disease historically suffer from poor outcome,” said Elias Jabbour, MD, U.S. lead investigator of the FELIX study and professor of Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center, Houston, Texas. “The clinical benefit and improvements in survival demonstrated by obe-cel have the potential to redefine the standard of care in the adult relapsed/refractory B-ALL setting.”
Of the 153 r/r B-ALL patients enrolled patients in the FELIX study, 127 (
The primary end point was overall remission (CR/CRi). In the pivotal cohort of patients, (cohort IIA (n=94)), the CR/CRi for patients who received at least one infusion of obe-cel was
Median overall survival (OS) was 15.6 months and estimated 6- and 12-month overall survival rates were
Of the 127 patients infused (pooled across all study cohorts), 99 patients responded. Of the responders, 18 patients (
Median duration of CAR T persistence by droplet digital PCR (ddPCR) in peripheral blood was 17.8 months.
Obe-cel was associated with minimal immunotoxicity. CRS and Immune effector cell-associated neurotoxicity syndrome (ICANS) rates (Grade ≥3) were
Obe-cel was approved by the Food & Drug Administration (FDA) under the brand name AUCATZYL® (obecabtagene autoleucel) on November 8, 2024. Marketing authorization applications (MAAs) for obe-cel [in adult r/r ALL] are being reviewed by the regulators in both the EU and the UK, with a submission to the European Medicines Agency (EMA) accepted in March 2024, and a submission accepted by the UK MHRA in August 2024.
Roddie C, et al "Obecabtagene autoleucel in B-cell acute lymphoblastic leukemia" N Engl J Med 2024; DOI: 10.1056/NEJMoa2406526
About Autolus Therapeutics plc
Autolus is a biopharmaceutical company developing next-generation, programmed T cell therapies 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, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has an FDA approved product, 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
About obe-cel FELIX clinical trial
Autolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint was overall response rate, and the secondary endpoints included duration of response, MRD negative complete remission rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660]
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the market opportunity for AUCATZYL®, Autolus’ development and commercialization of its product candidates, and the timing of data announcements and regulatory submissions. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 21, 2024 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.
Contact:
Amanda Cray
+1 617-967-0207
a.cray@autolus.com
Olivia Manser
+44 (0) 7780 471 568
o.manser@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
